anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Eslicarbazepine acetate 800 mg twice daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: ESL 800 mg once-daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial
Intervention: Iron sucrose
Trial phase: Phase 3
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1285
Group description: Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Eligibility criteria:
Inclusion Criteria:

Male or female subjects > or = to 18 years of age.
Chronically impaired renal function.
Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: ESL 1200 mg once daily

Eslicarbazepine acetate : Scored tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: ESL 400 mg twice-daily

Eslicarbazepine acetate : Scored tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: ESL 600 mg twice daily

Eslicarbazepine acetate : Scored tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: ESL 800 mg once-daily

Eslicarbazepine acetate : Scored tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: ESL 800 mg twice daily

Eslicarbazepine acetate : Scored tablets
Eligibility criteria:
Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
Intervention: Diphenhydramine
Trial phase: Not Applicable
ATC code: D04AA32 | D04AA33 | R06AA02 | R06AA52
SMILES: CN(C)CCOC(c1ccccc1)c1ccccc1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM
Eligibility criteria:
Inclusion Criteria:

Age 18-55
No active medical conditions
BMI between 20-30
Able and willing to perform/tolerate pain procedures
Able to communicate in English

Exclusion Criteria:

Lifetime substance use disorder, except for alcohol abuse/dependence in remission
Use of opiates in last 3 months
Ongoing marijuana use
Acute or chronic pain
Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
Current use of prescribed or over the counter pain medications
Previous adverse reaction to opiate medications or diphenhydramine
Use of tobacco or caffeine on study days
Intervention: Ergocalciferol
Trial phase: Not Applicable
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Males/females between the ages 10 through 18 years,
Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
All subjects will be able to take the prescribed vitamin D by mouth,
All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
All subjects must reside in an in-patient psychiatric facility.

Exclusion Criteria:

Pregnant or lactating women,
Patients with mental retardation (intelligence quotient < 50),
Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
Subjects with known history of parathyroid disorder,
Subjects with acquired or congenital disorders of vitamin D metabolism,
Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
Subjects taking any weight loss medications, such as orlistat, and sibutramine,
Subjects on medications that might affect glucose levels, such as insulin or metformin.
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Monthly zoledronic acid in addition to chemotherapy
Eligibility criteria:
Inclusion Criteria:

Histologically documented non-small cell lung cancer, Stages 3B, 4 or recurrent
Pleural effusion cytologically proven to be malignant
0 or 1 prior chemotherapy regimens for non-small cell lung cancer (adjuvant chemotherapy post resection, or concurrent chemo-radiation therapy counts as one regimen regardless of number of agents used.)
Planning to start chemotherapy for non-small cell lung cancer (treatment regimen at discretion of treating physician but must include one or more of the following agents:cisplatin,carboplatin,docetaxel,paclitaxel, pemetrexed,gemcitabine,vinorelbine) Patients may receive anti-angiogenesis agents (bevacizumab) in addition to chemotherapy, but patients treated solely with tyrosine kinase inhibitors or growth-factor receptor blockers are not eligible.
Prior radiation therapy is permitted.
Performance status 0,1,2
Serum creatinine less than 2.0 or estimated creatinine clearance over 30cc/min by Calcroft/Gault equation
Estimated life expectancy over 3 months
Signed informed consent
Age greater than 18 years
Patients who have clinical indication for Zometa treatment such as lytic bone metastases or hypercalcemia can be included

Exclusion Criteria:

Pregnant or lactating
Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
Patients who undergo any procedure other than thoracentesis for drainage of effusion.Patients may have had more than one thoracentesis prior to study. Patients who have large bore chest tube placement, permanent transthoracic catheter (Pleurex), medical pleurodesis or thoracoscopy are excluded.
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular);dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks)or planned dental or jaw surgery (e.g.extraction, implants).