anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 2
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Eligibility criteria:
Key Inclusion Criteria:

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

Key Exclusion Criteria:

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
Other criteria apply
Intervention: Bravelle
Trial phase: Phase 4
SMILES: CCC(C)C1NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CC(C)C)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(C(C)O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 232
Group description: Bravelle

Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
Eligibility criteria:
Inclusion Criteria:

patients undergoing in vitro fertilization

Exclusion Criteria:

risk of ovarian hyperstimulation syndrome
Intervention: Minocycline
Trial phase: Phase 1 | Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Minocycline 100 mg orally every 12 hours
Eligibility criteria:
Inclusion Criteria:

HIV infection prior to study entry
Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by cluster of differentiation 4 (CD4) criteria in Uganda
Negative serum or urine pregnancy test for women of childbearing potential
Willingness to use birth control
Age 18-65 years
AIDS Dementia Scale Stage 0.5 OR 1
Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
Ability and willingness of subject or legal guardian/ representative to give written informed consent
Resident within a 20km radius of Kampala city

Exclusion Criteria:

Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
Confounding neurological disorders as defined in the protocol
Central nervous system infections or cancers as defined in the protocol
Systemic lupus
Thyroid disease diagnosed within 24 weeks prior to entry
Breastfeeding
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
Any esophageal or other condition that would interfere with the swallowing of the study medication
Use of excluded drugs as defined by the protocol
Intervention: Letrozole
Trial phase: Phase 2
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective
Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range
Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue
Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment
18 years of age or older
Life expectancy of 3 months or more
ECOG Performance Status 0, 1, or 2
No limit to number of prior chemotherapies or biologics
Normal organ function as outlined in the protocol
Resolution of clinically significant toxicities related to prior therapies

Exclusion Criteria:

Pre-menopausal women
Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
Palliative radiotherapy within 2 weeks of study entry
Major surgery within 2 weeks of study entry
Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)
Participants may not be receiving any other concomitant investigational agents
Uncontrolled brain or central nervous system metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
Eligibility criteria:
Inclusion Criteria:

Male or female aged greater than 40 years with COPD Current or ex-smokers

Exclusion Criteria:

Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Tenofovir
Trial phase: Phase 2
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).

CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites.
Eligibility criteria:
Inclusion Criteria:

Individual must identify as a male who has sex with other men (MSM);
At least 18 years of age;
HIV negative serostatus on baseline rapid oral HIV antibody test;
Self-reported methamphetamine use within the previous 72 hours and test positive for methamphetamine metabolites at baseline;
Self-reported unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months;
Self-reports no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
Willing to comply with study requirements (i.e., monitored urine testing three times per week, meet with physician within first week of enrollment, begin medication immediately following an unexpected high-risk sexual exposure, and contact the clinic and meet with physician within 92 hours of unexpected high-risk sexual exposure).

Exclusion Criteria:

Does not identify as a male who has sex with other men;
Under 18 years of age;
HIV positive, by self-report or as indicated by the results on the baseline rapid oral HIV antibody test;
Self-reports any previous hypersensitivity to any of the components of Truvada;
Has not used methamphetamine in the previous 72 hours and does not test positive for methamphetamine metabolites;
Has not had unprotected anal intercourse with an HIV-positive or status unknown partner within the previous 3 months;
Unwilling to comply with study requirements.
Intervention: [19-[2-[[2-[2-[3-[2-[2-[[2-[[10,19-Diethyl-14,18-dioxo-7-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-19-yl]oxy]-2-oxoethyl]amino]-2-oxoethoxy]ethoxy]-2,2-bis[2-[2-[[2-[[10,19-diethyl-14,18-dioxo-7-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-19-yl]oxy]-2-oxoethyl]amino]-2-oxoethoxy]ethoxymethyl]propoxy]ethoxy]acetyl]amino]acetyl]oxy-10,19-diethyl-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate
Trial phase: Phase 2
ATC code: L01CE03
SMILES: CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(CC)OC(=O)CNC(=O)COCCOCC(COCCOCC(=O)NCC(=O)OC1(CC)C(=O)OCc2c1cc1n(c2=O)Cc2c-1nc1ccc(OC(=O)N3CCC(N4CCCCC4)CC3)cc1c2CC)(COCCOCC(=O)NCC(=O)OC1(CC)C(=O)OCc2c1cc1n(c2=O)Cc2c-1nc1ccc(OC(=O)N3CCC(N4CCCCC4)CC3)cc1c2CC)COCCOCC(=O)NCC(=O)OC1(CC)C(=O)OCc2c1cc1n(c2=O)Cc2c-1nc1ccc(OC(=O)N3CCC(N4CCCCC4)CC3)cc1c2CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: NKTR-102 IV every 3 weeks
Eligibility criteria:
Inclusion Criteria:

metastatic colorectal cancer
tumor with k-ras mutation

Exclusion Criteria:

More than 1 prior regimen for treatment of metastatic disease
Intervention: Sertindole
Trial phase: Phase 3
ATC code: N05AE03
SMILES: O=C1NCCN1CCN1CCC(c2cn(-c3ccc(F)cc3)c3ccc(Cl)cc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4905
Group description: Normally in the range of 4 to 20 mg/day
Eligibility criteria:
Inclusion Criteria:

The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
The patient has been diagnosed with schizophrenia
Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
The patient is at least 18 years of age
The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

The last treatment taken by the patient was sertindole or risperidone
The patient has never previously received any antipsychotic drug therapy
The patient has contraindications to treatment with either sertindole or risperidone
In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
The patient is homeless
The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4904
Group description: Normally in the range of 2 to 8 mg/day
Eligibility criteria:
Inclusion Criteria:

The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
The patient has been diagnosed with schizophrenia
Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
The patient is at least 18 years of age
The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

The last treatment taken by the patient was sertindole or risperidone
The patient has never previously received any antipsychotic drug therapy
The patient has contraindications to treatment with either sertindole or risperidone
In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
The patient is homeless
The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
Intervention: CID 3081884
Trial phase: Phase 3
ATC code: L03AX13
SMILES: CC(=O)O.CC(N)C(=O)O.NC(CCC(=O)O)C(=O)O.NC(Cc1ccc(O)cc1)C(=O)O.NCCCCC(N)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Age: 18 - 45 years
Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.
Able to provide written informed consent prior to enrollment
Willing and able to comply with the protocol requirements for the duration of the study

For women of child bearing potential:

A negative urine pregnancy test o
Willing to practice an acceptable method of birth control •
Willing to receive a steroidal regimen

Exclusion Criteria:

A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
Current use of any approved disease modifying agents for treatment of MS
Prior clinical episode of optic neuritis in either eye
Bilateral AON
Inability to undergo study evaluations in both eyes
Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
Retrogeniculate visual loss
Refractive error of greater than +6 or -6 diopters
Neuromyelitis Optica (Devic's disease)
Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
Known ocular conditions that preclude dilation
Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
Diabetes Mellitus Types I or II
Gastric bypass surgery
Current use of chemotherapy or radiotherapy
Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
Use of an investigational drug within 30 days prior to randomization
Intervention: FLORBETAPIR
Trial phase: Phase 3
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 152
Group description: End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
Eligibility criteria:
Inclusion Criteria (autopsy cohort):

Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
Can tolerate a 10 minute PET scan; and
Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Inclusion Criteria (specificity cohort):

Cognitively and neurologically healthy males and females 18 to 40 years of age;
Who had no known risk factors for AD, including:
Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotype was determined after enrollment and was not disclosed to healthy control subjects). Scans from subjects carrying an ApoE ε4 allele were not included in the primary specificity analysis, but were included in an exploratory analysis;
First degree relative with a known progressive dementing disorder;
History of cognitive decline;
History of neurologic, neurodegenerative, or psychiatric disease;
History of head trauma; or
Evidence of brain abnormality on a MRI scan;
Who performed in an age-appropriate normal range on the Wechsler Logical Memory I & II, story A;
Who could tolerate a 10-minute PET scan; and
Who provided informed consent before any study procedures were performed.

Exclusion Criteria:

Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
Have any major, focal structural loss of brain matter;
Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
Are females of childbearing potential who are pregnant or not using adequate contraception.
Intervention: FLORBETAPIR
Trial phase: Phase 3
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 74
Group description: Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
Eligibility criteria:
Inclusion Criteria (autopsy cohort):

Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
Can tolerate a 10 minute PET scan; and
Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Inclusion Criteria (specificity cohort):

Cognitively and neurologically healthy males and females 18 to 40 years of age;
Who had no known risk factors for AD, including:
Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotype was determined after enrollment and was not disclosed to healthy control subjects). Scans from subjects carrying an ApoE ε4 allele were not included in the primary specificity analysis, but were included in an exploratory analysis;
First degree relative with a known progressive dementing disorder;
History of cognitive decline;
History of neurologic, neurodegenerative, or psychiatric disease;
History of head trauma; or
Evidence of brain abnormality on a MRI scan;
Who performed in an age-appropriate normal range on the Wechsler Logical Memory I & II, story A;
Who could tolerate a 10-minute PET scan; and
Who provided informed consent before any study procedures were performed.

Exclusion Criteria:

Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
Have any major, focal structural loss of brain matter;
Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
Are females of childbearing potential who are pregnant or not using adequate contraception.