anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Adapalene
Trial phase: Phase 1
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 years and older
Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study.
Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%).
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Intervention: Adapalene
Trial phase: Phase 1
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 years and older
Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study.
Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%).
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Intervention: Adapalene
Trial phase: Phase 1
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 75
Group description: Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 years and older
Subjects with healthy skin as determined by the clinical grader.

Exclusion Criteria:

Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study
Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%)
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
Intervention: Salsalate
Trial phase: Phase 2
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
HIV-infected
Evidence of durable virologic suppression, i.e., must have HIV-1 RNA < 400 copies/ml at study entry and for at least 12 weeks prior to entry
On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks prior to study entry
No intention to stop or modify ARV regimen during the study period

Exclusion Criteria:

Current pregnancy or breast feeding, or women of child bearing age who refuse or are unable to use appropriate methods for contraception during the study period
Any of the following conditions: diabetes (2 fasting glucose levels > 126 mg/dL or confirmed random glucose level > 200), creatinine clearance < 50, aspirin-sensitive asthma, COPD, history of bleeding gastric or duodenal ulcer, hepatic dysfunction, active hepatitis B or C, and any active infectious or inflammatory condition
Need for regular use of any of the following medications: salsalate, aspirin, non-steroidal antiinflammatories (NSAIDS), corticosteroids, warfarin or other anticoagulation therapy, phenytoin, valproic acid, carbonic anhydrase inhibitors, lithium, probenecid or sulfinpyrazone
Consumption of alcohol on a daily basis
Active use of illicit drugs
Unable to attend follow-up appointments
Allergy to any salicylic acid-containing medication or salsalate
AST or ALT > 2 upper limit of normal (ULN) within 6 months prior to study entry
Intervention: Velac
Trial phase: Phase 4
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O.CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(OP(=O)(O)O)C(O)C2O)N(C)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
Subjects must sign written informed consent and agree to come for all study visits.

Exclusion Criteria:

Use of experimental drugs within 1 month prior to initiation of study therapy.
Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
History of hypersensitivity to any of the formulation components;
Facial skin cancer or facial actinic keratosis;
Use of any photosensitizing agents.
Use of isotretinoin within the last 6 months.
Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
Intervention: Quinine
Trial phase: Phase 2
ATC code: C01BA01 | C01BA51 | C01BA71 | M09AA72 | P01BC01
SMILES: C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
Eligibility criteria:
Inclusion Criteria:

The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
The patient is a child that weighs between 5 and 15 kg (kilogram)

The patient has falciparum malaria as evidenced by

Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided >500 P Falciparum /mcl) and /or
Positive RDT (rapid diagnostic test)for malaria

The patient has either

severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial.
Ability to tolerate oral therapy
Patient has received any treatment with an artemisinin or quinine in the last 24 hours
Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
Patient is allergic or intolerant to artemisinins.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 180
Group description: 8 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day
Eligibility criteria:
Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely (e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written informed consent for study procedures; and 5) residing in the geographic area for at least 12 months.

Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable to communicate in English; 2) Have a current diagnosis of psychosis and/or manic depression; 3) have a current medical condition that would make using transdermal nicotine patch unsafe (e.g., allergy to latex, serious, abnormal ECG reading)- participants with asthma, diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal heart rhythm, an arrhythmia) will be permitted to enroll in the study with medical clearance from the participant's physician or the study physician; 4) have had a heart attack within the past 6 months, 5) are pregnant or planning to become pregnant or lactating, or 6) are currently enrolled or plan to enroll in another research or smoking cessation program within the next 12 months.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 173
Group description: 24 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day
Eligibility criteria:
Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely (e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written informed consent for study procedures; and 5) residing in the geographic area for at least 12 months.

Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable to communicate in English; 2) Have a current diagnosis of psychosis and/or manic depression; 3) have a current medical condition that would make using transdermal nicotine patch unsafe (e.g., allergy to latex, serious, abnormal ECG reading)- participants with asthma, diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal heart rhythm, an arrhythmia) will be permitted to enroll in the study with medical clearance from the participant's physician or the study physician; 4) have had a heart attack within the past 6 months, 5) are pregnant or planning to become pregnant or lactating, or 6) are currently enrolled or plan to enroll in another research or smoking cessation program within the next 12 months.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 172
Group description: 52 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day
Eligibility criteria:
Inclusion Criteria: Participants will be: 1) males and females over age 18 who smoke at least 10 cigarettes/day; 2) able to communicate in English; 3) able to use NRT safely (e.g., no allergy to latex, no serious abnormal ECG reading); 4) able to provide written informed consent for study procedures; and 5) residing in the geographic area for at least 12 months.

Exclusion Criteria: Participants will be ineligible for the trial if they: 1) are unable to communicate in English; 2) Have a current diagnosis of psychosis and/or manic depression; 3) have a current medical condition that would make using transdermal nicotine patch unsafe (e.g., allergy to latex, serious, abnormal ECG reading)- participants with asthma, diabetes, hypertension, or heart disease (e.g., coronary artery disease, abnormal heart rhythm, an arrhythmia) will be permitted to enroll in the study with medical clearance from the participant's physician or the study physician; 4) have had a heart attack within the past 6 months, 5) are pregnant or planning to become pregnant or lactating, or 6) are currently enrolled or plan to enroll in another research or smoking cessation program within the next 12 months.
Intervention: Pritelivir
Trial phase: Phase 2
SMILES: Cc1nc(N(C)C(=O)Cc2ccc(-c3ccccn3)cc2)sc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
Eligibility criteria:
Inclusion Criteria:

Adult, Immunocompetent men and women in good health of any ethnic group
History of recurrent episodes of genital herpes for at least 12 months
Seropositive for Herpes Simplex Virus HSV Type 2
Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

Present episode of genital herpes
Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Intervention: Pritelivir
Trial phase: Phase 2
SMILES: Cc1nc(N(C)C(=O)Cc2ccc(-c3ccccn3)cc2)sc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
Eligibility criteria:
Inclusion Criteria:

Adult, Immunocompetent men and women in good health of any ethnic group
History of recurrent episodes of genital herpes for at least 12 months
Seropositive for Herpes Simplex Virus HSV Type 2
Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

Present episode of genital herpes
Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Intervention: Pritelivir
Trial phase: Phase 2
SMILES: Cc1nc(N(C)C(=O)Cc2ccc(-c3ccccn3)cc2)sc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
Eligibility criteria:
Inclusion Criteria:

Adult, Immunocompetent men and women in good health of any ethnic group
History of recurrent episodes of genital herpes for at least 12 months
Seropositive for Herpes Simplex Virus HSV Type 2
Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

Present episode of genital herpes
Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Intervention: Pritelivir
Trial phase: Phase 2
SMILES: Cc1nc(N(C)C(=O)Cc2ccc(-c3ccccn3)cc2)sc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: AIC316: 400 mg QWK, Oral administration
Eligibility criteria:
Inclusion Criteria:

Adult, Immunocompetent men and women in good health of any ethnic group
History of recurrent episodes of genital herpes for at least 12 months
Seropositive for Herpes Simplex Virus HSV Type 2
Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

Present episode of genital herpes
Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Intervention: Ramelteon
Trial phase: Phase 3
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Ramelteon 8 mg oral before bedtime
Eligibility criteria:
Inclusion Criteria:

Obstructive sleep apnea
Insomnia
Age>60

Exclusion Criteria:

Cognitive impairment
Active alcohol or substance abuse
Active use of other sedative-hypnotic agents
Active use of fluvoxamine (drug interaction with Ramelteon
Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
Severe Chronic Obstructive Pulmonary Disease
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 684ug dose group
Eligibility criteria:
Inclusion Criteria:

Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
Patients with any signs of intraocular inflammation in either eye at screening.
Patients who have received any prior intravitreal injections in the study eye.
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.

Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
Eligibility criteria:
Inclusion Criteria:

Voluntarily requesting pregnancy termination
Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated by fetal biparietal diameter on clinic ultrasound.
Be able and willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

Known severe maternal respiratory disease or upper respiratory infection or sinus blockage
Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must have a documented normal international normalized ratio (INR) prior to procedure if on anticoagulation)
Multiple pregnancy
Fetal demise, if more than 2 weeks difference exists between known gestational age (by previous US dating) and gestational size on current ultrasound.
Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 38
Group description: 21mg, 14mg, 7mg

Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
Eligibility criteria:
Inclusion Criteria:Inclusion Criteria:

Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence
Smokes at least 10 cigarettes per day for the three months prior to enrollment
Currently seeking treatment for nicotine dependence
Medically healthy on the basis of physical examination and medical history, vital signs,
Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
Currently seeking treatment for nicotine disorders
History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
History of significant recent violent behavior
Blood pressure greater than 150/90
History of eating disorders
History of allergic reaction to any of the study medications
Pregnant