anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Selegiline
Trial phase: Phase 4
ATC code: N04BD01
SMILES: C#CCN(C)[C@H](C)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Patients who preferred oral selegiline
Eligibility criteria:
Inclusion Criteria:

Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity
Male or female outpatients
Age 30-90 years
Current use of levodopa and oral selegiline (5-10 mg /day), stable for at least 1 month and well tolerated
Positive treatment response to current anti-parkinsonian medications in the opinion of the investigator
Acceptable contraception for females of child bearing potential
Willing and able to comply with study procedures.
Willing and able to give written informed consent prior to beginning any study procedures.

Exclusion Criteria:

Atypical parkinsonism due to drugs, metabolic disorders, encephalitis, trauma, or other neurodegenerative diseases.
Significant cognitive or psychiatric impairment which, in the opinion of the investigator, would interfere with the ability to complete all the tests required in the protocol.
Participation in another clinical drug trial within the previous four weeks.
Patients on any medications contraindicated with Zelapar (including meperidine/Demerol, tramadol, methadone, propoxyphene, dextromethorphan, other selegiline products)
Patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar, or previous exposure to orally disintegrating selegiline
History of melanoma
Unstable/uncontrolled medical problems
History of drug/alcohol abuse
Patients currently taking rasagiline
Intervention: Rosiglitazone
Trial phase: Phase 4
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone

rosiglitazone: 4 mg daily for 6 months
Eligibility criteria:
Inclusion Criteria:

Age 10 - 20 years
Pubertal level of Tanner stage III-V and menarchal
BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
Established diagnosis of diabetes
Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
Vitamin D deficiency (<10ng/mL)
Hyperkalemia (K>5.0 meq/L)
Positive pregnancy test (serum)
Intervention: Gianvi
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C.CC12CCC(=O)C=C1C1CC1C1C2CCC2(C)C1C1CC1C21CCC(=O)O1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol

drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months
Eligibility criteria:
Inclusion Criteria:

Age 10 - 20 years
Pubertal level of Tanner stage III-V and menarchal
BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
Established diagnosis of diabetes
Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
Vitamin D deficiency (<10ng/mL)
Hyperkalemia (K>5.0 meq/L)
Positive pregnancy test (serum)
Intervention: Riociguat
Trial phase: Phase 1
ATC code: C02KX05
SMILES: COC(=O)N(C)c1c(N)nc(-c2nn(Cc3ccccc3F)c3ncccc23)nc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
Eligibility criteria:
Inclusion Criteria:

Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure], PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood pressure]) must be in place independent of the trial.

Exclusion Criteria:

Acute exacerbation of COPD,
Pre-existing lung disease other than COPD,
Acute or severe chronic left heart failure,
Severe coronary artery disease,
Uncontrolled arterial hypertension;
Severe left ventricular hypertrophy,
Congenital or acquired valvular or myocardial disease,
Systolic blood pressure < 100 mmHg,
Heart rate < 55 bpm or >105 bpm,
PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg,
PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg,
Severe hepatic insufficiency,
Severe renal insufficiency.
Intervention: Riociguat
Trial phase: Phase 1
ATC code: C02KX05
SMILES: COC(=O)N(C)c1c(N)nc(-c2nn(Cc3ccccc3F)c3ncccc23)nc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
Eligibility criteria:
Inclusion Criteria:

Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure], PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood pressure]) must be in place independent of the trial.

Exclusion Criteria:

Acute exacerbation of COPD,
Pre-existing lung disease other than COPD,
Acute or severe chronic left heart failure,
Severe coronary artery disease,
Uncontrolled arterial hypertension;
Severe left ventricular hypertrophy,
Congenital or acquired valvular or myocardial disease,
Systolic blood pressure < 100 mmHg,
Heart rate < 55 bpm or >105 bpm,
PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg,
PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg,
Severe hepatic insufficiency,
Severe renal insufficiency.
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: 107
Group description: Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent
Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2

Exclusion Criteria:

Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Intervention: Calcipotriol plus hydrocortisone
Trial phase: Phase 3
SMILES: C=C1C(=CC=C2CCCC3(C)C2CCC3C(C)C=CC(O)C2CC2)CC(O)CC1O.CC12CCC(=O)C=C1CCC1C2C(O)CC2(C)C1CCC2(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 321
Group description: Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
Systemic treatment with vitamin D preparations above 500 IU per day
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcemia
Intervention: Tacalcitol
Trial phase: Phase 3
ATC code: D05AX04
SMILES: C=C1/C(=C\C=C2/CCC[C@]3(C)[C@@H]([C@H](C)CC[C@@H](O)C(C)C)CC[C@@H]23)C[C@@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 316
Group description: Tacalcitol once daily for up to 8 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
Systemic treatment with vitamin D preparations above 500 IU per day
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcemia
Intervention: Curcumin
Trial phase: Phase 2
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Patients receive curcumin PO BID for 12 months.

Curcumin: Given PO
Eligibility criteria:
Inclusion Criteria:

Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

Exclusion Criteria:

Female patients of childbearing age not on effective birth control
Pregnant women
White blood cell count (WBC) < 3500/ml
Platelet count < 100,000/ml
Blood urea nitrogen (BUN) > 25mg%
Creatinine > 1.5mg%
Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
Malignancy other than nonmelanoma skin cancer
Active bacterial infection
Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
Patients with a history of peptic ulcer disease
Patients on warfarin or plavix
Intervention: Cladribine
Trial phase: Phase 3
ATC code: L01BB04 | L04AA40
SMILES: Nc1nc(Cl)nc2c1ncn2[C@H]1C[C@H](O)[C@@H](CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 186
Group description: Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Eligibility criteria:
Inclusion Criteria:

Randomized in Trial 25643 and satisfied one of the following:

Completed randomized treatment course and scheduled visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray

All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:

Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
Leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
Absolute lymphocyte count (ALC) = 1.02 to 3.36*10^3 per microliter
Absolute neutrophil count (ANC) = 2.03 to 8.36*10^3 per microliter
Platelet count = 140 to 450*10^3 per microliter
Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

Participants who were not enrolled in Trial 25643
Participant has moderate to severe renal impairment
Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Intervention: Cladribine
Trial phase: Phase 3
ATC code: L01BB04 | L04AA40
SMILES: Nc1nc(Cl)nc2c1ncn2[C@H]1C[C@H](O)[C@@H](CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 186
Group description: Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Eligibility criteria:
Inclusion Criteria:

Randomized in Trial 25643 and satisfied one of the following:

Completed randomized treatment course and scheduled visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray

All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:

Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
Leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
Absolute lymphocyte count (ALC) = 1.02 to 3.36*10^3 per microliter
Absolute neutrophil count (ANC) = 2.03 to 8.36*10^3 per microliter
Platelet count = 140 to 450*10^3 per microliter
Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

Participants who were not enrolled in Trial 25643
Participant has moderate to severe renal impairment
Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Intervention: Cladribine
Trial phase: Phase 3
ATC code: L01BB04 | L04AA40
SMILES: Nc1nc(Cl)nc2c1ncn2[C@H]1C[C@H](O)[C@@H](CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 244
Group description: Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Eligibility criteria:
Inclusion Criteria:

Randomized in Trial 25643 and satisfied one of the following:

Completed randomized treatment course and scheduled visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray

All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:

Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
Leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
Absolute lymphocyte count (ALC) = 1.02 to 3.36*10^3 per microliter
Absolute neutrophil count (ANC) = 2.03 to 8.36*10^3 per microliter
Platelet count = 140 to 450*10^3 per microliter
Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

Participants who were not enrolled in Trial 25643
Participant has moderate to severe renal impairment
Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1