anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Amantadine
Trial phase: Phase 3
ATC code: N04BB01
SMILES: NC12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants during Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week.
Eligibility criteria:
Inclusion Criteria:

Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
H&Y stage 2.5-3
Presence of freezing of gait (FOG) as determined by UPDRS Part I score > 2
Ability to walk for 2 minutes in the ON and OFF state
Stable regimen of PD medications for 30 days prior to screening
Ability to comply with the study procedures
If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
Willing and able to provide informed consent.

Exclusion Criteria:

Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
Presence of freezing of gait (FOG) ONLY in medications ON state
Presence of freezing of gait (FOG) ONLY in medications OFF state
Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) <20
Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15>5
Presence of clinically significant hallucinations
Inability to sign informed consent
Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr > 2)
If female, be pregnant or lactating
Intervention: Fortical
Trial phase: Not Applicable
ATC code: H05BA01
SMILES: CC(C)CC(NC(=O)C(CCCCN)NC(=O)CNC(=O)C(CC(C)C)NC(=O)C(NC(=O)C1CSSCC(N)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C(C)O)C(=O)N1)C(C)C)C(=O)NC(CO)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CCCNC(=N)N)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(C(=O)NCC(=O)NC(CO)C(=O)NCC(=O)NC(C(=O)N1CCCC1C(N)=O)C(C)O)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects will received nasal calcitonin once daily

nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)
Eligibility criteria:
Inclusion Criteria:

age ≥18 or greater
an established diagnosis of XLH
fasting serum calcium ≤10.5 mg/dl
fasting PTH at time of screen </= 1.7 times the upper limit of normal

Exclusion Criteria:

estimated creatinine clearance < 60 cc/min and/or serum creatinine > 1.5 mg/dl;
serum 25(OH)vitamin D < 30 ng/ml. Potential study subjects who have a serum 25(OH)vitamin D < 30 ng/ml will be supplemented with 25(OH)vitamin D to achieve a serum value > 30 ng/ml and then re- screened
inability to comply with instructions and appropriate follow up visits
treatment with agents that may skeletal metabolism such as glucocorticoids, bisphosphonates, denosumab, teriparatide, estrogen and anticonvulsants.
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.

Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.

At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject with well-characterized Epilepsy according to the 1989 International League Against Epilepsy (ILAE) classification
Subject with Epilepsy who the investigator expects will benefit from Levetiracetam (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of LEV
Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day)
Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs) including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

Subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
Subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Subject has history or presence of known psychogenic nonepileptic seizures
Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
Subject is pregnant or lactating
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Not Applicable
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: This group will receive a standard dose Tacrolimus and MMF. This will follow standard of care protocol at Northwestern Memorial Hospital's Comprehensive Transplant Center.

Tacrolimus with MMF: Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
Eligibility criteria:
Inclusion Criteria:

Subjects should be adults between 18 and 70 years of age
Subjects can be either gender or of any ethnic background
Subjects should be single organ recipients (kidney only)
Subjects must be able to understand the protocol and provide informed consent.
Recipient of living donor kidney transplants
Panel reactive antibody (PRA) < 20%

Exclusion Criteria:

Subjects with End Stage Renal Disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
Inability to fully understand the purpose of the study and the inability to sign the informed consent
Subjects with a significant or active infection
Subjects who are pregnant or nursing females
Subjects with a history of severe hyperlipidemia not controlled with statins, patients with Cholesterol > 400mg/dl
Subjects with a platelet count < 100,000mm3, WBC < 2,000mm3 (or clinical practice)
Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
Intervention: Everolimus
Trial phase: Not Applicable
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: This group will receive a low dose Tacrolimus with concentration controlled Everolimus

Group 2: Tacrolimus with Everolimus.: From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
Eligibility criteria:
Inclusion Criteria:

Subjects should be adults between 18 and 70 years of age
Subjects can be either gender or of any ethnic background
Subjects should be single organ recipients (kidney only)
Subjects must be able to understand the protocol and provide informed consent.
Recipient of living donor kidney transplants
Panel reactive antibody (PRA) < 20%

Exclusion Criteria:

Subjects with End Stage Renal Disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
Inability to fully understand the purpose of the study and the inability to sign the informed consent
Subjects with a significant or active infection
Subjects who are pregnant or nursing females
Subjects with a history of severe hyperlipidemia not controlled with statins, patients with Cholesterol > 400mg/dl
Subjects with a platelet count < 100,000mm3, WBC < 2,000mm3 (or clinical practice)
Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
Intervention: Febuxostat
Trial phase: Phase 4
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.

Febuxostat: One 40 mg tablet once a day for 6 months
Eligibility criteria:
Inclusion Criteria:

Age > 21 years
Gout
Hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women).

Exclusion Criteria:

Current treatment with insulin, azathioprine, mercaptopurine, or theophylline.
Treatment with febuxostat, allopurinol or other uricosuric agents (including losartan, probenecid) within the past year
Uncontrolled hypertension (clinic systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg within the past 6 months)
Uncontrolled diabetes mellitus (HbA1c > 7%)
estimated GFR < 60 ml/min by MDRD
Elevated liver function tests (AST or ALT greater than 3 times the upper limit of normal)
Pregnancy
Intervention: Simvastatin
Trial phase: Phase 1 | Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: placebo: placebo
Eligibility criteria:
Inclusion Criteria:

Men and women, age 40 years and above
Meet American College of Rheumatology criteria for knee OA
Knee pain most days of the week for the past month
Knee pain > 5/10 after exercise intervention
Capable of undertaking exercise intervention
Stable cardiovascular function
Able to return for all clinic visits
Able to read and understand the informed consent document

Exclusion Criteria:

Use of a walker to ambulate or inability to ambulate
Other forms of arthritis
Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
History of myocardial infarction
Blood Pressure > 140 systolic/100 diastolic
Scheduled for and likely to need joint replacement surgery in the next 3 months
Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
Intervention: Tetrodotoxin
Trial phase: Phase 2
SMILES: NC1=NC(O)C2C3OC4(O)OC(C(O)C2(N1)C4O)C3(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
Eligibility criteria:
Inclusion Criteria:

If female, not of childbearing potential.
Patients with documented neuropathic pain
Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
Patients with stable moderate to severe neuropathic pain
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria:

History of peripheral neuropathy attributed to any cause other than chemotherapy.
Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
Patients with abnormal kidney function.
Patients with bone metastases.
Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
Patients with current uncontrolled asthma or lung disease.
Patients with significant heart disease.
Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
Females who are pregnant or nursing
Intervention: Tetrodotoxin
Trial phase: Phase 2
SMILES: NC1=NC(O)C2C3OC4(O)OC(C(O)C2(N1)C4O)C3(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
Eligibility criteria:
Inclusion Criteria:

If female, not of childbearing potential.
Patients with documented neuropathic pain
Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
Patients with stable moderate to severe neuropathic pain
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria:

History of peripheral neuropathy attributed to any cause other than chemotherapy.
Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
Patients with abnormal kidney function.
Patients with bone metastases.
Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
Patients with current uncontrolled asthma or lung disease.
Patients with significant heart disease.
Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
Females who are pregnant or nursing
Intervention: Tetrodotoxin
Trial phase: Phase 2
SMILES: NC1=NC(O)C2C3OC4(O)OC(C(O)C2(N1)C4O)C3(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Tetrodotoxin: Comparison of different dosages of Tetrodotoxin
Eligibility criteria:
Inclusion Criteria:

If female, not of childbearing potential.
Patients with documented neuropathic pain
Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
Patients with stable moderate to severe neuropathic pain
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria:

History of peripheral neuropathy attributed to any cause other than chemotherapy.
Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
Patients with abnormal kidney function.
Patients with bone metastases.
Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
Patients with current uncontrolled asthma or lung disease.
Patients with significant heart disease.
Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
Females who are pregnant or nursing
Intervention: Ethyl 2-(4-fluoro-7-methylsulfonyloxy-6,7,8,9-tetrahydropyrido[1,2-a]indol-10-yl)acetate
Trial phase: Phase 2
SMILES: CCOC(=O)Cc1c2n(c3c(F)cccc13)CC(OS(C)(=O)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

not pregnant or breastfeeding, and not planning to become pregnant during the study
history of symptoms of persistent asthma for at least one year

current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments:

use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of asthma controller medications; OR
use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation
no history of smoking OR no smoking within <1 year with a smoking history of ≤10 pack-years
ability to maintain a constant day/night, awake/sleep cycle
agreement to not change habitual consumption of beverages or food containing caffeine throughout the study
Body Mass Index (BMI) of 15 to 40 kg/m^2

Exclusion Criteria:

myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months
hospitalization within past ≤4 weeks
major surgical procedure within past ≤4 weeks
participation in a clinical study involving an investigational drug within past ≤4 weeks
current regular use or recent (within past ≤5 years) past abuse of alcohol (>14 drinks/week) or illicit drugs
donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study
evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD)
emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks
respiratory tract infection requiring antibiotic treatment within past ≤8 weeks
evidence of active, clinically significant sinus disease within past ≤1 week
history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks
history of HIV
hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose
clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems
current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years, study participation may be allowed
evidence of uncontrolled hypertension