anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Buprenorphine
Trial phase: Phase 1
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
Eligibility criteria:
Inclusion Criteria Include:

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).
A history of substance or alcohol abuse within the past 5 years.
Females who are nursing.
Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.
Intervention: Buprenorphine
Trial phase: Phase 1
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
Eligibility criteria:
Inclusion Criteria Include:

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).
A history of substance or alcohol abuse within the past 5 years.
Females who are nursing.
Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.
Intervention: Buprenorphine
Trial phase: Phase 1
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
Eligibility criteria:
Inclusion Criteria Include:

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).
A history of substance or alcohol abuse within the past 5 years.
Females who are nursing.
Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Eligibility criteria:
Inclusion Criteria:

Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department

Exclusion Criteria:

Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score >2
Intervention: Estrone
Trial phase: Phase 2
ATC code: G03CA07 | G03CC04
SMILES: [H][C@@]12CCC(=O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days

Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Eligibility criteria:
Inclusion Criteria:

painful peripheral neuropathy resulting from chemotherapy
pain must be present for minimum of 6 months
must be able to read/understand English
stable analgesics regimens allowed (no change for past 7 days)

Exclusion Criteria:

painful peripheral neuropathy that is not the result of chemotherapy
pregnant women
patients unable to wean off anti-epileptics
patients currently receiving chemotherapy known to cause peripheral neuropathy
patients with pacemakers or implanted defibrillators
patients with vena cava or aneurysm clips
patients with a history of epilepsy
Intervention: Yttrium
Trial phase: Phase 3
SMILES: [Y]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 264
Group description: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Eligibility criteria:
Inclusion Criteria:

Positive antinuclear antibodies (ANA) at Screening (Visit 1)
Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

Subjects who are breastfeeding, pregnant, or plan to become pregnant
Subjects with active, severe SLE disease activity which involves the renal system
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
Subjects with the evidence of an immunosuppressive state
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
Subjects with substance abuse or dependence or other relevant concurrent medical condition
Subjects with history of thromboembolic events within 1 year of screening Visit.
Subjects with significant hematologic abnormalities
Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
Subject has previously participated in this study or has previously received epratuzumab treatment.
Intervention: Buprenorphine
Trial phase: Phase 2
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
Eligibility criteria:
Inclusion Criteria:

Availability to attend clinic 6 days a week for approximately 30-60 minutes.
Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.

Exclusion Criteria:

Unstable medical condition or stable medical condition that would interact with study medications or participation.
History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).
Intervention: Buprenorphine
Trial phase: Phase 2
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
Eligibility criteria:
Inclusion Criteria:

Availability to attend clinic 6 days a week for approximately 30-60 minutes.
Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.

Exclusion Criteria:

Unstable medical condition or stable medical condition that would interact with study medications or participation.
History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).
Intervention: Casein Kinase inhibitor A51
Trial phase: Phase 2 | Phase 3
SMILES: Cn1ncc(-c2nc(NC3CCC(N)CC3)ncc2Cl)c1CC1CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

BTX-A: 100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand
Eligibility criteria:
Inclusion Criteria:

Healthy male or non-pregnant female
Age 16 and older
If <18, parent/legal guardian willing to sign consent and accompany to visits
Diagnosis of hyperhidrosis disease with a severity score (HDSS) of 3 or 4
Treatment types of topical antiperspirants, iontophoresis, or systemic anticholinergics have failed to treat
Able to come to 5 clinical visits during the study period

Exclusion Criteria:

Diagnosis of neuromuscular disease such as peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, or motor neuropathy)
Diagnosis of neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome)
Diagnosis of dysphagia
Individuals with surgical implants such as pacemakers, orthopedic hardware, etc.
Individuals who are Immunocompromised
Systemic infectious illness or infection at the injection site(s)
Known hypersensitivity to any ingredient in the formulation of the drug
Organic cause of hyperhidrosis
Known allergy to the ingredients in the general anesthesia
Diagnosis of cardiac/pulmonary issues or disease
Women who are pregnant or suspected to be pregnant
Intervention: Yttrium
Trial phase: Phase 3
SMILES: [Y]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 264
Group description: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Eligibility criteria:
Inclusion Criteria:

Positive antinuclear antibodies (ANA) at Screening (Visit 1)
Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
Active moderate to severe SLE disease as demonstrated by SLEDAI total score.
On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

Subjects who are breastfeeding, pregnant, or plan to become pregnant
Subjects with active, severe SLE disease activity which involves the renal system
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
Subjects with the evidence of an immunosuppressive state
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
Subjects with substance abuse or dependence or other relevant concurrent medical condition
Subjects with history of thromboembolic events within 1 year of screening Visit.
Subjects with significant hematologic abnormalities
Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
Subject has previously participated in this study or has previously received epratuzumab treatment.
Intervention: Nabiximols
Trial phase: Phase 3
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Eligibility criteria:
Inclusion Criteria (abbreviated):

The participant had advanced cancer for which there was no known curative therapy
The participant had a clinical diagnosis of cancer related pain, which was not wholly alleviated with their current optimized opioid treatment
The participant received an optimized maintenance dose of Step 3 opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
The participant received a daily maintenance dose Step 3 opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
The participant was using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

The participant had any planned clinical interventions that would have affected their pain (for example, chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
The participant was using or had used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
The participant had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator, would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
The participant had significantly impaired renal function
The participant had significantly impaired hepatic function
Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom was not to be used in conjunction with a female condom as this may not have proven effective)