anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Neratinib
Trial phase: Phase 1
ATC code: L01EH02
SMILES: CCOc1cc2ncc(C#N)c(Nc3ccc(OCc4ccccn4)c(Cl)c3)c2cc1NC(=O)/C=C/CN(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Neratinib 160 mg qd
Eligibility criteria:
Inclusion criteria

Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
Life expectancy of at least 12 weeks and adequate performance status
Adequate bone marrow, kidney and liver function
Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control

Exclusion Criteria

Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
Inadequate cardiac function
Surgery within 2 weeks of first dose of HKI-272
Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
Significant gastrointestinal disorder with diarrhea as a major symptom
Pregnant or breast feeding women
Intervention: Melatonin
Trial phase: Phase 3
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 394
Group description: Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
Eligibility criteria:
Inclusion Criteria:

Male or female and aged 18-80 years.
Are willing to take a 6-SMT level evaluation test.
Suffering from primary insomnia according to DSM-IV. criteria (307.42 primary insomnia, Appendix 24.3) .
Sleep latency of at least 20 minutes.
Have not been using benzodiazepines (BZD) and non-BZD hypnotics for the past 2 weeks or more.
Have not been using psychotropic treatments for the past 3 months or more.
Are stabilized on non-psychotropic treatments for more than 1 month.
Are willing to sign a written informed consent to participate in the study.

Exclusion Criteria:

Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
Pharmacological immunosuppression.
Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition).
Severe neurological, psychiatric disorders (especially psychosis, anxiety and depression) and alcoholism.
Other serious diseases that could interfere with patient assessment.
Pregnant or breast feeding women.
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Eligibility criteria:
Inclusion Criteria::

age 18 - 65 inclusive
able to read and understand informed consent
informed consent given
currently being treated with an SSRI for depression or dysthymia
currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI
have normal safety lab values at screen
if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study
female subjects of child bearing age need to use an acceptable form of birth control throughout the study Exclusion Criteria:- being pregnant, breastfeeding, or planning to become pregnant within 4 months
suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD, panic disorder, or personality disorder severe enough to interfere with study participation
suffer from an unstable or serious medical disorder
having a medical disorder that could be the cause of the sexual dysfunction
taking a medication that is metabolized by hepatic enzyme CYP2D6
having used a MAOI within 15 days of proposed start of duloxetine treatment
having a known hypersensitivity to duloxetine or any of its ingredients
having taken viagra or related drug within 3 months prior to starting SSRI treatment
requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic medication
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 384
Group description: Subjects who received active drug
Eligibility criteria:
Inclusion Criteria:

18 years of age and older
Stable fiber therapy
Normal colonoscopy/sigmoidoscopy
Able to refrain from use of medications known to treat or associated with constipation symptoms
Experiences abdominal discomfort/pain associated with bowel movements
Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria:

Diarrhea-predominant or alternating (diarrhea & constipation cycling) IBS, or constipation other than that associated with IBS
Open gastrointestinal or abdominal surgery prior to IBS onset
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Intervention: Atomoxetine
Trial phase: Not Applicable
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
Eligibility criteria:
Inclusion Criteria:

Age 12-19
Provided assent/consent
attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist <=22
At least one non-nicotine substance use disorder (SUD) by KSADS
Plans to live locally for 4 months
Willing to participate in cognitive behavioral therapy (CBT)

Exclusion Criteria:

No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
No allergy to atomoxetine
No narrow angle glaucoma
No serious medical illness
Not pregnant
Not unwilling to use an effective form of contraception during the trial
No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
Intervention: Mycapssa
Trial phase: Not Applicable
ATC code: H01CB02
SMILES: CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Octreotide :

Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of PWS confirmed by chromosome analysis
Ages 5 years to 21 years
BMI for age ≥ (greater-than or equal to)85th percentile
Written informed consent and assent obtained and willingness to comply with the study schedule and procedures
Free T4, Thyroid stimulating hormone (TSH) values in the normal range (either endogenous or with thyroxine replacement)

Exclusion Criteria:

Patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
Concomitant use of an investigational drug or Octreotide in the past year
Use of steroids for longer than 7 days within the past 30 days
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 3
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 288
Group description: In initial open-label phase, participants were applied Clobetasol Propionate 0.05% (W/W) shampoo topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams [50 Milliliter]).
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18 years or older.
Subjects with moderate to severe scalp psoriasis

Exclusion Criteria:

Subjects who needed systemic treatment for their body psoriasis

Subjects with a washout period for topical treatment(s) on the scalp less than:

Corticosteroids 2 weeks
All other anti-psoriasis medications 2 weeks

Subjects with a washout period for systemic treatment(s) less than:

PUVA therapy 4 weeks
Biological therapies 12 weeks
Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
Treatment known to worsen psoriasis 2 weeks
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 3
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: In maintenance double-blind phase, participants presented with a good efficacy (GSS <= 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse [i.e., GSS > 2] participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week).
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18 years or older.
Subjects with moderate to severe scalp psoriasis

Exclusion Criteria:

Subjects who needed systemic treatment for their body psoriasis

Subjects with a washout period for topical treatment(s) on the scalp less than:

Corticosteroids 2 weeks
All other anti-psoriasis medications 2 weeks

Subjects with a washout period for systemic treatment(s) less than:

PUVA therapy 4 weeks
Biological therapies 12 weeks
Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
Treatment known to worsen psoriasis 2 weeks
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Subjects must have been diagnosed with irritable bowel syndrome by a physician
Subjects must have had gastrointestinal symptoms for 2 or more days per week for > 6 months

Exclusion Criteria:

Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive disorder
Current (within past 6 months) diagnosis of major depressive disorder or substance abuse disorder
Active suicidal/homicidal ideation
Pregnant women or women of child-bearing potential not using an approved methods of contraception
Individuals with an unstable medical condition that in the opinion of the investigator would interfere with the interpretation of symptoms
Intervention: Methylnaltrexone
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Eligibility criteria:
Inclusion Criteria:

Male and female participants at least 18 years of age.
All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
Participants must sign an informed consent form (ICF).
Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion Criteria:

Participants who received any investigational new drug in the 30 days prior to screening visit.
Females who are pregnant or lactating.
Intervention: Methylnaltrexone
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant).
Eligibility criteria:
Inclusion Criteria:

Male and female participants at least 18 years of age.
All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
Participants must sign an informed consent form (ICF).
Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion Criteria:

Participants who received any investigational new drug in the 30 days prior to screening visit.
Females who are pregnant or lactating.
Intervention: Lacosamide
Trial phase: Phase 2
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Lacosamide Tablet 400mg daily (administered twice daily)
Eligibility criteria:
Inclusion Criteria:

Males or females, 18 to 65 years old
Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

Symptomatic regional or structural rheumatic disease
Diagnosed neuropathic pain syndrome
Receiving treatment with neurostimulating devices
Significant psychopathology
History of chronic alcohol or drug abuse within 6 months prior to Screening
Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
Other medical conditions that could compromise the subject's ability to participate in the study
Intervention: MIDOMAFETAMINE
Trial phase: Phase 2
SMILES: CNC(C)Cc1ccc2c(c1)OCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.

3,4-methylenedioxymethemphetmaine (MDMA_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Posttraumatic stress disorder arising from war or terrorism-related events.
PTSD still remains after at last one treatment, with treatment including psychotherapy or pharmacotherapy.
May meet criteria for a mood disorder.
Must be at least 18 years old.
Must be able to stop taking psychiatric medication from the start of the study until the two-month follow-up.
May continue seeing an outside therapist during the study, but cannot increase the length or frequency of treatments.
Must be able to follow all the rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption
Must be willing to stay overnight in the clinic after each experimental session until the non-drug session occurring the next morning.
Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.
If a woman of childbearing potential, must have a negative pregnancy test and must agree to use an effective form of birth control.
Must be able to speak and read Hebrew.

Exclusion Criteria:

Cannot have a non-war or non-terrorism event as significant contributor to PTSD symptoms.
Cannot have history of or be diagnosed with psychotic disorder or bipolar affective disorder - 1.
Cannot be diagnosed with dissociative identity disorder, an eating disorder with active purging or borderline personality disorder.
Cannot have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.
Cannot weigh less than 50 or more than 105 kg.
Cannot have used "Ecstasy" more than five times during lifetime or in the past six months.
Cannot present a serious suicide risk or be likely to require hospitalization during the course of the study.
Cannot require ongoing concomitant therapy with a psychotropic drug.
Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.
Unable to give adequate consent.
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: 3
Group description: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Eligibility criteria:
Inclusion Criteria:

Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.

Exclusion Criteria:

Subjects who have pain or disability in a site other than the operative joint.
Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
Subjects whose body mass index (BMI) is 40 or more.
Intervention: Artecom
Trial phase: Phase 3
SMILES: CC1CCC2C(C)C(OC(=O)CCC(=O)O)OC3OC4(C)CCC1C32OO4.COc1ccc2nc3cc(Cl)ccc3c(Nc3cc(CN4CCCC4)c(O)c(CN4CCCC4)c3)c2n1.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 848
Group description: Pyronaridine artesunate (180:60mg)

Pyronaridine artesunate: once a day for 3 days
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the ages of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or documented history of fever in the previous 24 hours and,
Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/µl of blood
Written informed consent provided by patient and/or parent/guardian/spouse.
Ability to swallow oral medication.

Exclusion Criteria:

Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
Mixed Plasmodium infection.
Severe vomiting or severe diarrhoea.
Known history or evidence of clinically significant disorders.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Presence of febrile conditions caused by diseases other than malaria.
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, mefloquine or artesunate or other artemisinins.
Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by positive urine test.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Presence of significant renal or hepatic impairment.
Receipt of an investigational drug within the past 4 weeks.
Known active Hepatitis A IgM, Hepatitis B surface antigen or Hepatitis C antibody.
Known seropositive HIV antibody.
Previous participation in any clinical study with PA.