anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 14
Group description: (20-160mg/d, bid) for 12 weeks

Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)

4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes

there were no serious adverse events in this group
Eligibility criteria:
Inclusion Criteria:

age 13-18 years
English-speaking
DSM diagnoses that have an FDA indication for SGA use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of early-onset schizophrenia spectrum disorders; bipolar I disorder mania (and BP-NOS); irritability associated with autism spectrum disorder, as well as severe mood dysregulation (SMD) according to Leibenluft et al. (2011) with an ABC-irritability score of >/=18 Sexually active girls must agree to use two effective forms of birth control or be abstinent
Participant has a primary caretaker who has known the child well for at least 6 months before study entry Primary caretaker is able to participate in study appointments
Ability of child to participate in all aspects of the protocol per investigator clinical judgment.

Exclusion Criteria:

Major neurological or medical illnesses that affect weight (e.g., unstable thyroid disease), require a prohibited systemic medication (e.g., diabetes mellitus [insulin], chronic renal failure [steroids); Fasting glucose > 125 mg/dL on 2 occasions during screening
Any medication (other than currently prescribed psychotropic medications) that would significantly alter weight
Antidepressants not allowed for at least 2 weeks in BP-I or BP-NOS patients
DSM-IV diagnosis of anorexia or bulimia nervosa
DSM-IV diagnosis of Substance Dependence disorder (other than tobacco dependence) within the past month
Initial urine toxicology screen and follow-up screen indicate ongoing use of illicit substance
Hypersensitivity to ZIP or UC antipsychotics
Pregnant, breast feeding or unwilling to comply with contraceptive requirements
Screening or baseline QTc > 450 msec
IQ < 55
Significant risk for dangerousness to self or to others
Ongoing or previously undisclosed child abuse requiring new department of social service intervention.
Intervention: Rapastinel
Trial phase: Phase 2
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Single IV infusion of GLYX-13, 5mg/kg,

GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
Eligibility criteria:
Inclusion Criteria:

For all Individuals

Male and female subjects
Ages 18 - 40 years
General intellectual abilities falling broadly within the average range (estimated intelligence quotient (IQ) between 80 - 119)
Sufficient ability to understand study requirements and provide written informed consent

For Patients

-Diagnosis of Schizophrenia or Schizoaffective Disorder

Exclusion Criteria:

For all individuals:

History of neurologic disorder or systemic medical condition that may interfere with central nervous system function
History of seizures
History of heard injury with loss of consciousness or concussion
Positive screen for drugs of abuse: cocaine, marijuana, phencyclidine, ketamine, opioid, or other agent that is being abused in the opinion of the investigator
Females who are currently pregnant or plan to become pregnant during the study period
History of allergy, sensitivity, or intolerance to N-methyl-D-Aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
History of any ferromagnetic object in the body
Presence of any medical device or implant for which MRI is contraindicated including cardiac pacemaker, aneurysm clip, cochlear implant, copper intrauterine device (IUD), neurostimulator, or any other device deemed unsafe
Bullet or shrapnel in body
Metallic braces or permanent retainer
Significant claustrophobia

For Healthy Individuals

Personal history of any Axis I disorder according to the Structured Clinical Interview for the DSM-5 (SCID-5) criteria
History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder)

For Patients

Treatment with Clozaril
Change in medication within 1 month
Hospitalization within 1 month
Intervention: Nilotinib
Trial phase: Phase 2
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Patients resistant or intolerant to either imatinib or dasatinib
Eligibility criteria:
Key Inclusion Criteria:

Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
Karnofsky ≥ 50% for patients > 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age
Adequate renal, hepatic and pancreatic function
Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
Written informed consent

Key Exclusion Criteria:

Treatment with strong CYP3A4 inhibitors or inducers
Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
Acute or chronic liver, pancreatic or severe renal disease
History of pancreatitis or chronic pancreatitis.
Impaired cardiac function
No evidence of active graft vs host and <3mo since Stem Cell Transplant
Total body irradiation (TBI) or craniospinal radiation therapy <6months
Hypersensitivity to the active ingredient or any of the excipients including lactose.
the criteria regarding pregnancy and contraception
Active or systemic bacterial, fungal, or viral infection
known Hepatitis B, Hepatitis C, or HIV infection
Intervention: Promega
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Single Omegaven® Intervention Arm

Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Eligibility criteria:
Inclusion Criteria:

Children 0-18 years of age
Patients will be PN-dependent and expected to continue PN for at least 30 days
Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
Direct bilirubin > 2.0 mg/dl
Signed patient informed consent
Signed patient assent where applicable.

Exclusion Criteria:

Pregnancy
Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
The patient is allergic to eggs/shellfish
The patient has a severe hemorrhagic disorder
The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
The parent or guardian or child unwilling to provide consent or assent.
Intervention: Clonidine
Trial phase: Phase 4
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
Eligibility criteria:
Inclusion Criteria:

women in labor at term pregnancy
healthy
epidural analgesia in place
breakthrough pain in advanced labor

Exclusion Criteria:

chronic pain syndrome
receiving systemic opioids within 4 hours
receiving chronic antidepressants, clonidine, opioids
Intervention: Prasterone
Trial phase: Phase 3
ATC code: A14AA07 | G03EA03 | G03XX01
SMILES: [H][C@]1(O)CC[C@@]2(C)C(=CC[C@]3([H])[C@]2([H])CC[C@]2(C)C(=O)CC[C@@]32[H])C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (non hysterectomized or hysterectomized)
Women between 40 and 75 years of age
Willing to participate in the study and sign an informed consent
Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
Women having a vaginal pH above 5
Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion Criteria:

Undiagnosed abnormal genital bleeding
Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
The administration of any investigational drug within 30 days of screening visit
Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Intervention: Leuprolide Acetate
Trial phase: Not Applicable
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones

Estrogen suppression: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function
Eligibility criteria:
Inclusion Criteria:

Body mass index < 30 kg/m2
Normal menstrual cycles
Premenopausal

Exclusion Criteria:

irregular menstrual cycles defined as 2 or more missed cycles in the previous year
on hormonal contraceptive or menopausal therapy
positive pregnancy test
intention to become pregnant or start hormonal contraceptive therapy during the period of study
lactation
severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores < -2.0)
abnormal vaginal bleeding
thyroid dysfunction
uncontrolled hypertension
exercising at least 30 minutes per day at a moderate to vigorous intensity >1 d/wk) over the past 6 months
Intervention: Amphetamine
Trial phase: Phase 2
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.
Eligibility criteria:
Inclusion Criteria:

Healthy men and women
Age 50 to 70 years old
Ability to walk on a treadmill for 15 minutes.

Exclusion Criteria:

Age less than 50 or greater than 70 years of age.
A history of difficult veins/difficulty obtaining blood samples
Unwilling to follow the procedures of the trial
Participated in more than 2 sessions per week of strenuous exercise in the last month
Unable to tolerate the ingredients in NutraStem® or placebo, or have food allergies
Intentionally lost or gained 10 or more pounds of body weight in the last 3 months
Acute illness
Severe co-morbid disease
Use of any prescription or non-prescription products for antioxidant regimen or stem cell supplement within the past 4 weeks
Diabetic
Uncontrolled hypertension
Recent cardiovascular event (past 36 months), or a family history of sudden death or heart attacks before the age of 55
Body Mass Index (BMI) of less than 20 or greater than 35 m/kg2;
Participated in a clinical trial in the past 4 weeks
Take methadone, insulin, anticoagulants (blood thinners), MAO's or similar medications
Anticipate the need for surgery of any type during the entire study;
Plan to donate blood or blood products during the study or for thirty (30) days following the study
Active peptic ulcer disease or reliable history of gastrointestinal bleeding within the past five (5) years
Recurrent or a history of intestinal disorders that may interfere with the absorption of the product
Any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks

AZD1722
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 to 80 years, inclusive.
Body mass index between 18 and 45 kg/m2, inclusive.
Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
Stage 3 CKD
MSSBP ≥130 mmHg
Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria:

Urinary albumin: UACR > 3500 mg/g
History of a renal transplant
MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Liraglutide 0.6 mg daily administration for 6 months
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT)
Male or female aged above 30 years
Have a negative pregnancy test at screening (women of child bearing potential only)
Body mass index (BMI) of 25kg/m2 or greater
On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study
Established microalbuminuria
Estimated glomerular filtration rate (eGFR) 30ml/min/1.73m2 or above by Modification of Diet in Renal Disease (MDRD) formula

Exclusion Criteria:

Patients with any cognitive impediment that preclude the patient from giving free and informed consent
Patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment
Patients with stage 4-5 renal disease, defined as an eGFR of 30ml/min/1.73m2 or less
Patients who have used a GLP-1 agent in the last 6 months
Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study
Previous pancreatitis
Hypersensitivity to GLP-1 analogues
Proliferative diabetic retinopathy
Any other contraindications, as per the SmPC for liraglutide
Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements
Concurrent treatment with an investigational drug or participation in another clinical trial
Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
Intervention: Nicotine
Trial phase: Phase 1
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: A single dose of Nicotine Mint Gum (2 mg) to be chewed.
Eligibility criteria:
Inclusion Criteria:

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents
Intervention: Nicotine
Trial phase: Phase 1
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 77
Group description: A single dose of Reference Nicotine Gum (2 mg) to be chewed.
Eligibility criteria:
Inclusion Criteria:

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents
Intervention: Nicotine
Trial phase: Phase 1
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 79
Group description: A single dose of Nicotine Mint Gum (4 mg) to be chewed.
Eligibility criteria:
Inclusion Criteria:

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents
Intervention: Nicotine
Trial phase: Phase 1
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 81
Group description: A single dose of Reference Nicotine Gum (4 mg) to be chewed.
Eligibility criteria:
Inclusion Criteria:

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents
Intervention: Ezetimibe
Trial phase: Phase 3
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Men aged between 18-60 years
Waist circumference > 102 cm
HDL-cholesterol < 1.1 mmol/L
Triglycerides > 1.7 mmol/L
Fasting blood glucose > 6.1 mmol/L
Normal blood pressure (<130/85)

Exclusion Criteria:

Women
Men < 18 or > 60 years
Smokers (> 1 cigarette/day)
Body weight variation > 10% during the last 6 months prior to the study baseline
Subjects with a previous history of cardiovascular disease
Subjects with type 2 diabetes
Subjects with a monogenic dyslipidemia
Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
Subjects with endocrine or gastrointestinal disorders
History of alcohol or drug abuse within the past 2 years
Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Intervention: 6-Acryloyloxyhexyl phosphate
Trial phase: Phase 3
SMILES: C=CC(=O)OCCCCCCO.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: PA21
Eligibility criteria:
Inclusion Criteria:

Patients age 20 or older, regardless of gender.
Receiving stable maintenance hemodialysis 3 times a week.
Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

Patients having history of a pronounced brain / cardiovascular disorder.
Patients having severe gastrointestinal disorders.
Patients having severe hepatic disorders.
Intervention: 2-(Chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride
Trial phase: Phase 3
SMILES: C=CCN.Cl.ClCC1CO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Sevelamer hydrochloride
Eligibility criteria:
Inclusion Criteria:

Patients age 20 or older, regardless of gender.
Receiving stable maintenance hemodialysis 3 times a week.
Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

Patients having history of a pronounced brain / cardiovascular disorder.
Patients having severe gastrointestinal disorders.
Patients having severe hepatic disorders.
Intervention: 6-Acryloyloxyhexyl phosphate
Trial phase: Phase 3
SMILES: C=CC(=O)OCCCCCCO.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: PA21
Eligibility criteria:
Inclusion Criteria:

Receiving stable maintenance hemodialysis 3 times a week
Dialysis patients with hyperphosphatemia

Exclusion Criteria:

Patients having history of a pronounced brain / cardiovascular disorder
Patients having severe gastrointestinal disorders
Patients having severe hepatic disorders