anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Roflumilast
Trial phase: Phase 4
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Active arm including patients who receive the study drug (500µg Roflumilast once daily)

Roflumilast: Roflumilast coated tablet, 500µg oral application, once daily in the morning
Eligibility criteria:
Inclusion Criteria:

Over 40 years of age
Smoking history of at least 10 pack years
Chronic obstructive pulmonary disease at Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II - IV diagnosed according to standard criteria.
History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year

Exclusion Criteria:

Insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period
History of acute exacerbation 4 weeks prior to run-in period
Diagnosis of alpha-1-antitrypsin deficiency
Diagnosis of asthma
Acute respiratory infections (e.g. pneumonia)
Severe acute infectious diseases (e.g. active hepatitis, HIV)
Lung cancer
Bronchiectasis
Interstitial lung disease
Any other relevant lung disease
Acute myocardial infarction
Systolic left ventricular dysfunction
Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade IV
Haemodynamically significant cardiac arrhythmias or heart valve deformations
Peripheral arterial occlusive disease
Acute or chronic renal/hepatic failure
Active malignancy
Autoimmune disease
Pregnant or breastfeeding women
Women no using or not willing to use adequate contraceptive measures for the duration of the trial
Hypersensitivity to study medication or placebo
Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour
Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption
Intervention: Odanacatib
Trial phase: Phase 1
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
Eligibility criteria:
Inclusion Criteria:

Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
X-ray evidence of closed epiphyses (growth plate) at the hand
Nonsmoker

Exclusion Criteria:

Pregnant or unwilling to undergo pregnancy test
History of stroke, chronic seizures, or major neurological disorder
History of malignant neoplastic disease (cancer)
Breastfeeding
Primary growth disorder
Any disease affecting the stomach or proximal small intestine resulting in malabsorption
Received treatment which might have influenced bone turnover, including anabolic steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or excess vitamin D, or cyclosporine or initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing medications, or thyroid hormone unless on a stable dose for at least 1 month and has a normally functioning thyroid gland
Previous treatment with any marketed or experimental bisphosphonate within 12 months
History of, or evidence for, any clinically relevant metabolic bone disease (other than glucocorticoid-induced bone loss) including but not limited to primary hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and osteogenesis imperfecta within previous 3 years
History of hypothyroidism
Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse
Unable to swallow tablets
Intervention: Odanacatib
Trial phase: Phase 1
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
Eligibility criteria:
Inclusion Criteria:

Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
X-ray evidence of closed epiphyses (growth plate) at the hand
Nonsmoker

Exclusion Criteria:

Pregnant or unwilling to undergo pregnancy test
History of stroke, chronic seizures, or major neurological disorder
History of malignant neoplastic disease (cancer)
Breastfeeding
Primary growth disorder
Any disease affecting the stomach or proximal small intestine resulting in malabsorption
Received treatment which might have influenced bone turnover, including anabolic steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or excess vitamin D, or cyclosporine or initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing medications, or thyroid hormone unless on a stable dose for at least 1 month and has a normally functioning thyroid gland
Previous treatment with any marketed or experimental bisphosphonate within 12 months
History of, or evidence for, any clinically relevant metabolic bone disease (other than glucocorticoid-induced bone loss) including but not limited to primary hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and osteogenesis imperfecta within previous 3 years
History of hypothyroidism
Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse
Unable to swallow tablets
Intervention: Odanacatib
Trial phase: Phase 1
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
Eligibility criteria:
Inclusion Criteria:

Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
X-ray evidence of closed epiphyses (growth plate) at the hand
Nonsmoker

Exclusion Criteria:

Pregnant or unwilling to undergo pregnancy test
History of stroke, chronic seizures, or major neurological disorder
History of malignant neoplastic disease (cancer)
Breastfeeding
Primary growth disorder
Any disease affecting the stomach or proximal small intestine resulting in malabsorption
Received treatment which might have influenced bone turnover, including anabolic steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or excess vitamin D, or cyclosporine or initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing medications, or thyroid hormone unless on a stable dose for at least 1 month and has a normally functioning thyroid gland
Previous treatment with any marketed or experimental bisphosphonate within 12 months
History of, or evidence for, any clinically relevant metabolic bone disease (other than glucocorticoid-induced bone loss) including but not limited to primary hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and osteogenesis imperfecta within previous 3 years
History of hypothyroidism
Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse
Unable to swallow tablets
Intervention: Dextromethorphan hydrobromide and quinidine sulfate
Trial phase: Phase 2
SMILES: Br.C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12.C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12.COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3.O=S(=O)(O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Nuedexta: Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
Eligibility criteria:
Inclusion Criteria:

18 to 60 years of age
Have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior
Diagnosis of autistic spectrum disorder based on the Diagnostic and Statistical Manual, 4th edition, Text Revised (DSM-IV-TR) criteria, developmental history, and Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during childhood through similar methods
Capable of giving informed consent, or have a legal guardian capable of giving consent on the subject's behalf; patient able to assent to participate
Mood issues and frontal lobe type perseveration issues
No medication changes within 30 days and no use of new medications during the course of the study except for non-related conditions approved by the investigators

Exclusion Criteria:

Clinically uncontrolled epilepsy
Cardiovascular conditions including cardiac or structural malformation heart failure, prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block
Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor
Known allergy to either dextromethorphan or quinidine
Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt Nuedexta
Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA) agonists or antagonists
Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome
Pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception
Other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject
Intervention: Clascoterone
Trial phase: Phase 2
ATC code: D10AX06
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CC)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: low dose of CB-03-01, 0.1% applied twice a day

CB-03-01: Topical cream, applied twice a day
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial

Subject has used any of the following topical anti-acne preparations or procedures on the face:

Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.

Subject has used the following systemic anti-acne medications:

Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
Retinoid therapy within six months of the initiation of treatment.
Intervention: Clascoterone
Trial phase: Phase 2
ATC code: D10AX06
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CC)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: medium dose of CB-03-01, 0.5% applied twice a day

CB-03-01: Topical cream, applied twice a day
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial

Subject has used any of the following topical anti-acne preparations or procedures on the face:

Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.

Subject has used the following systemic anti-acne medications:

Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
Retinoid therapy within six months of the initiation of treatment.
Intervention: Clascoterone
Trial phase: Phase 2
ATC code: D10AX06
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CC)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: high dose of CB-03-01, 1% applied once a day

CB-03-01: Topical cream, applied once a day
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial

Subject has used any of the following topical anti-acne preparations or procedures on the face:

Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.

Subject has used the following systemic anti-acne medications:

Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
Retinoid therapy within six months of the initiation of treatment.