anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Isoniazid
Trial phase: Not Applicable
ATC code: J04AC01 | J04AC51 | J04AM01 | J04AM02 | J04AM03 | J04AM04 | J04AM05 | J04AM06 | J04AM07 | J04AM08
SMILES: NNC(=O)c1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.

Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months.
Eligibility criteria:
Inclusion Criteria:

All subjects will be enrolled in the Longitudinal Study of the Porphyrias.

In patients with EPP the inclusion criteria are based on

clinical features
biochemical findings, as documented by laboratory reports of porphyria-specific testing performed after 1980
molecular findings documenting the identification of a mutation in FECH or ALAS2 genes (molecular evidence of EPP is required for inclusion in the study).

These data will be obtained from the Porphyria Rare Disease Clinical Research Consortium Longitudinal Study (RDCRN Protocol 7201). An individual must be willing to give written informed consent and be 18 years of age or greater.

Autosomal EPP (EPP) and X-linked protoporphyria (XLEPP)

Clinical features - a or b required

A history of non-blistering cutaneous photosensitivity, usually with early age of onset.
A diagnosis of EPP or XLEPP in a relative.

Biochemical findings

A marked increase in erythrocyte protoporphyrin [total erythrocyte protoporphyrin >200 ug/dL, or more than 1.5-fold increase relative to upper limit of normal of 80 ug/dL, with a predominance of free protoporphyrin (85-100% in EPP and 50-85% in XLEPP). Note: Methods in some laboratories for measuring free erythrocyte protoporphyrin (FEP) actually measure zinc protoporphyrin, so these results cannot be relied upon for diagnosis or characterizing the phenotype in EPP and XLEPP.
Increased plasma porphyrins with a fluorescence emission peak at ~634 nm.
Normal urinary porphyrins (except in patients with hepatobiliary impairment), and normal ALA and porphobilinogen (PBG).

Molecular findings - one of the following:

A disease causing FECH mutation trans to the IVS3-48C>T low expression FECH allele (aEPP)
Two disease-causing FECH mutations (EPP, recessive variant)
A gain-of-function ALAS2 C-terminal deletion/exon 11 mutation (XLEPP)

Exclusion Criteria:

Patients with a diagnosis of EPP that cannot be documented by DNA testing.
Patients with evidence of active liver injury as defined by serum transaminase concentrations greater than three times the upper limit of normal, those with a history of recent (within 3 months of enrollment) or ongoing alcohol abuse, those with diabetes mellitus requiring therapy, renal insufficiency (serum creatinine >2.0 mg/ml) or evidence of malnutrition (based on subnormal plasma concentration of transthyretin) will be ineligible for participation in the study.
Pregnant and/or lactating women will be excluded from the study.
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
Eligibility criteria:
Inclusion Criteria:

positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Eligibility criteria:
Inclusion Criteria:

positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
Intervention: Fluvastatin Sodium
Trial phase: Phase 4
SMILES: CC(C)n1c(C=CC(O)CC(O)CC(=O)[O-])c(-c2ccc(F)cc2)c2ccccc21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 218
Group description: Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).

Exclusion Criteria:

Patients with known hypersensitivity to fluvastatin or any of the excipients.
Dyslipidemia secondary to other causes.
Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Fluvastatin Sodium
Trial phase: Phase 4
SMILES: CC(C)n1c(C=CC(O)CC(O)CC(=O)[O-])c(-c2ccc(F)cc2)c2ccccc21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 218
Group description: Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).

Exclusion Criteria:

Patients with known hypersensitivity to fluvastatin or any of the excipients.
Dyslipidemia secondary to other causes.
Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Liquid intranasal oxytocin administered in a nasal spray.

Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Eligibility criteria:
Inclusion Criteria:

No current Axis I according to Diagnostic & Statistical Manual for Psychiatry-IV excluded diagnoses as determined by MINI or Structured Clinical Interview for Diagnosis psychiatric diagnostic interview completed within the past 6 months
Age 18 to 65
Subjects must be able to give informed consent and be willing and able to comply with study procedures.

Exclusion Criteria:

Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
Pregnant or lactating women.
Subjects currently taking hormones, such as estrogen.
Known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray.
Known hyponatremia or concurrent use of diuretics.
Subjects with a history of seizure disorder.
Intervention: Ketotifen
Trial phase: Phase 3
ATC code: R06AX17 | S01GX08
SMILES: CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Received ketotifen the active drug
Eligibility criteria:
Inclusion Criteria:

In order to qualify the subject:

must have been diagnosed with fibromyalgia by a medical doctor
must be between the ages of 18 to 65 years of age
must have a weekly overall body pain average score ≥ 4
must pass a screening questionnaire that calculates a physical impairment of ≥ 10
must be on stable doses of his/her current medication for at least past four weeks
must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary
must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team
must be willing to maintain a medication diary provided to him/her during the 10-week study period
must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
must agree to use a proven method of contraception to prevent pregnancy throughout this study

Exclusion Criteria:

The subject will not be allowed to participate if:

he/she has a history of seizures
he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
he/she has chronic thrombocytopenia (a low blood platelet count)
she is currently pregnant, are planning to become pregnant, or is breastfeeding
he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases)
he/she plans to undergo an elective surgery within the study timeline
he/she is in the process of filing, or plan to file for disability benefits within the study timeline
his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count)
he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone
Intervention: Eluxadoline
Trial phase: Phase 3
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 428
Group description: Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Eligibility criteria:
Inclusion Criteria:

Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

Participant has had a colonoscopy performed:

Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)

Since the onset (if applicable) of any of the following alarm features for participants of any age:

Participant has documented weight loss within the past 6 months
Participant has nocturnal symptoms
Participant has a familial history of first-degree relatives with colon cancer or
Participant has blood mixed with their stool (excluding blood from hemorrhoids).

Female participants must be:

Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
Abstinent, or
If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Participant has a history of diverticulitis within 3 months prior to Prescreening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

Participant has any of the following surgical history:

Cholecystectomy with any history of post cholecystectomy biliary tract pain
Any abdominal surgery within the 3 months prior to Prescreening
Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 3
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 479
Group description: Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Eligibility criteria:
Inclusion Criteria:

Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

Participant has had a colonoscopy performed:

Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)

Since the onset (if applicable) of any of the following alarm features for participants of any age:

Participant has documented weight loss within the past 6 months
Participant has nocturnal symptoms
Participant has a familial history of first-degree relatives with colon cancer or
Participant has blood mixed with their stool (excluding blood from hemorrhoids).

Female participants must be:

Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
Abstinent, or
If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Participant has a history of diverticulitis within 3 months prior to Prescreening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

Participant has any of the following surgical history:

Cholecystectomy with any history of post cholecystectomy biliary tract pain
Any abdominal surgery within the 3 months prior to Prescreening
Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 3
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 379
Group description: Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
Eligibility criteria:
Inclusion Criteria:

Participant is 18 to 80 years old
Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

2. Participant has had a colonoscopy performed:

Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)

Since the onset (if applicable) of any of the following alarm features for participants of any age

Participant has documented weight loss within the past 6 months
Participant has nocturnal symptoms
Participant has a familial history of first-degree relatives with colon cancer

Participant has blood mixed with their stool (excluding blood from hemorrhoids).

3. Female participants must be:

Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
Abstinent, or
If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Participant has a history of diverticulitis within 3 months prior to Prescreening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

Participant has any of the following surgical history:

Cholecystectomy with any history of post cholecystectomy biliary tract pain
Any abdominal surgery within the 3 months prior to Prescreening
Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 3
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 380
Group description: Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
Eligibility criteria:
Inclusion Criteria:

Participant is 18 to 80 years old
Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

2. Participant has had a colonoscopy performed:

Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)

Since the onset (if applicable) of any of the following alarm features for participants of any age

Participant has documented weight loss within the past 6 months
Participant has nocturnal symptoms
Participant has a familial history of first-degree relatives with colon cancer

Participant has blood mixed with their stool (excluding blood from hemorrhoids).

3. Female participants must be:

Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
Abstinent, or
If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Participant has a history of diverticulitis within 3 months prior to Prescreening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

Participant has any of the following surgical history:

Cholecystectomy with any history of post cholecystectomy biliary tract pain
Any abdominal surgery within the 3 months prior to Prescreening
Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.