anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects receiving SP-304 0.3 mg for 14 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
Subject has a body mass index (BMI) between 18 and 35 kg/m2.
Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
Subjects who meet the Rome III criteria for IBS.
Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects receiving SP-304 1.0 mg for 14 consecutive days
Eligibility criteria:
Inclusion Criteria:

Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
Subject has a body mass index (BMI) between 18 and 35 kg/m2.
Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
Subjects who meet the Rome III criteria for IBS.
Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects receiving SP-304 3.0 mg for 14 consecutive days
Eligibility criteria:
Inclusion Criteria:

Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
Subject has a body mass index (BMI) between 18 and 35 kg/m2.
Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
Subjects who meet the Rome III criteria for IBS.
Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects receiving SP-304 9.0 mg for 14 consecutive days
Eligibility criteria:
Inclusion Criteria:

Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
Subject has a body mass index (BMI) between 18 and 35 kg/m2.
Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
Subjects who meet the Rome III criteria for IBS.
Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Intervention: Alvelestat
Trial phase: Phase 2
SMILES: Cc1c(-c2ccnn2C)cc(C(=O)NCc2ccc(S(C)(=O)=O)cn2)c(=O)n1-c1cccc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: AZD9668 2x30mg bid
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COPD with symptoms over 1 year
FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
Ex-smokers for at least 12 months

Exclusion Criteria:

Past history or current evidence of clinically significant heart disease
Current diagnosis of asthma
Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Furosemide : Furosemide 0.3 mg/kg
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria include:

ASA PS I-III
Age 18 or older
Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)

Exclusion Criteria:

• ASA PS IV or V

Age less than 18
Emergency surgery due to severely elevated ICP/impending brainstem herniation
Concurrent use of diuretics for any indication
Infratentorial/posterior fossa/cerebellar tumor resection
Moderate/severe cardiac disease with limitation in contractility as measured by preoperative echocardiogram (EF < 30%)
Severe pulmonary hypertension as measured and/or observed by preoperative studies
Preoperative use of steroids (within 6 months, including those on standing doses)
Pregnancy
Intervention: Lusutrombopag
Trial phase: Phase 2
ATC code: B02BX07
SMILES: CCCCCCO[C@@H](C)c1cccc(-c2csc(NC(=O)c3cc(Cl)c(/C=C(\C)C(=O)O)c(Cl)c3)n2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
Eligibility criteria:
Inclusion Criteria:

A signed and dated written informed consent
Males and females ≥ 18 years of age
All subjects must agree to use barrier contraception
Diagnosis of ITP
Subjects > 60 years must have had a diagnostic bone marrow aspiration
Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs
Subjects receiving steroid therapy must be on a stable dose
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN)
Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1)

Exclusion Criteria:

History of clinically important hemorrhagic clotting disorder
Females who are pregnant, lactating, or taking oral contraceptives
History of alcohol/drug abuse or dependence within 1 year

Use of the following drugs or treatment prior to Visit 1 (Day 1):

Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
Within 8 weeks - rituximab
Within 2 weeks - platelet transfusions or plasmapheresis treatment
Within 4 weeks - use of anti-platelet or anti-coagulant drugs
Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin
History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Screening
Splenectomy within 4 weeks prior to Screening

Clinically significant laboratory abnormalities

Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP
Absolute neutrophil count < 1000/mm^3
Abnormal peripheral blood smear
Total bilirubin > 1.5 x upper limit of normal
Alanine aminotransferase (ALT) > 1.5 x upper limit of normal
Aspartate aminotransferase (AST) > 1.5 x upper limit of normal
Creatinine > 1.5 x upper limit of normal
Human immunodeficiency virus (HIV) positive
Hepatitis A immunoglobulin M antibody (IgM HAV) positive, hepatitis B surface antigen (HbsAg) or hepatitis C antibody (HCV) positive
Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal
Free thyroxine (T4) > 1.5 x upper limit of normal
Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Screening
Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
Exposure to an investigative medication within the past 30 days
Intervention: Lusutrombopag
Trial phase: Phase 2
ATC code: B02BX07
SMILES: CCCCCCO[C@@H](C)c1cccc(-c2csc(NC(=O)c3cc(Cl)c(/C=C(\C)C(=O)O)c(Cl)c3)n2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
Eligibility criteria:
Inclusion Criteria:

A signed and dated written informed consent
Males and females ≥ 18 years of age
All subjects must agree to use barrier contraception
Diagnosis of ITP
Subjects > 60 years must have had a diagnostic bone marrow aspiration
Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs
Subjects receiving steroid therapy must be on a stable dose
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN)
Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1)

Exclusion Criteria:

History of clinically important hemorrhagic clotting disorder
Females who are pregnant, lactating, or taking oral contraceptives
History of alcohol/drug abuse or dependence within 1 year

Use of the following drugs or treatment prior to Visit 1 (Day 1):

Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
Within 8 weeks - rituximab
Within 2 weeks - platelet transfusions or plasmapheresis treatment
Within 4 weeks - use of anti-platelet or anti-coagulant drugs
Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin
History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Screening
Splenectomy within 4 weeks prior to Screening

Clinically significant laboratory abnormalities

Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP
Absolute neutrophil count < 1000/mm^3
Abnormal peripheral blood smear
Total bilirubin > 1.5 x upper limit of normal
Alanine aminotransferase (ALT) > 1.5 x upper limit of normal
Aspartate aminotransferase (AST) > 1.5 x upper limit of normal
Creatinine > 1.5 x upper limit of normal
Human immunodeficiency virus (HIV) positive
Hepatitis A immunoglobulin M antibody (IgM HAV) positive, hepatitis B surface antigen (HbsAg) or hepatitis C antibody (HCV) positive
Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal
Free thyroxine (T4) > 1.5 x upper limit of normal
Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Screening
Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
Exposure to an investigative medication within the past 30 days
Intervention: Memantine
Trial phase: Not Applicable
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.

Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Normal IQ as estimated by the Wechsler Test of Adult Reading (WTAR)
Able to give consent
Able to live independently and complete activities of daily living
Stable frequency of seizures. There is no minimum/maximum criteria for the frequency of partial seizures. Those with infrequent secondary generalized seizures may participate, with infrequent seizures defined as two or fewer per year.
The subject's treating physician does not believe a change in anticonvulsant regimen to be warranted. The anticonvulsant drugs must remain unchanged during the 26 week trial.
Partial-onset seizures. Seizure type will be determined by clinical history, MRI, SPECT and/or PET imaging, and interictal and/or ictal EEG.
Either symptomatic or idiopathic seizures.

Exclusion Criteria:

Non-epileptic seizures
Prior surgical resection for treatment of seizures
Progressive neurologic illness (i.e. tumor evident on MRI)
Current alcohol or drug abuse, as this may affect memory by other mechanisms. This information may be obtained by self-report, from the referring physician or by medical record.
Diagnosis of Alzheimer's disease, nutritional deficiency, infection or metabolic/electrolyte disorder causing memory loss.
Non-native English speaking and/or multilingual.
Seizure(s) must not have occurred within 3 days of testing.
Subjects who are pregnant will not be eligible to take part in the study, as memantine is classified as a Pregnancy Category B drug and may pose risk to the fetus.
Women who are breastfeeding may not participate in this study.
Those with renal tubular acidosis or infections of the urinary tract will not be eligible for participation, as memantine is renally cleared and conditions that alkalinize the urine may reduce clearance of the drug.
Subjects with severe renal impairment, defined as a creatinine clearance of ≤29 mL/min, will be excluded as such patients may not tolerate the proposed dosing schedule.
Intervention: Malathion
Trial phase: Phase 2
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.

alpha-lipoic acid and acetyl-L-carnitine: none to report
Eligibility criteria:
Inclusion Criteria:

Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype
Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.

Exclusion Criteria:

More than 3 packed red blood transfusions in the past 12 months
Coexisting illness that could contribute to inflammation. These include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions.
Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks
Women who are pregnant, attempting to get pregnant, or breast feeding
Active participation in other investigational drug or device studies
Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.
Intervention: Sunitinib
Trial phase: Not Applicable
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.

Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.

Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
Eligibility criteria:
Inclusion Criteria:

Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
Patients must have adequate laboratory parameters:

Hematologic: Hb >9.0; WBC >3200 and platelets >100,000/mm3; Hepatic: Bilirubin <2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min

Men and women who are of childbearing potential must practice strict birth control for the duration of the study.
Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration.
The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration.

Exclusion Criteria:

Known brain metastases or significant pleural effusion or ascites.
Uncontrolled hypertension, diabetes, or other medical condition.
Major surgery within 21 days of registration.
Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
Prior therapy for GIST.
A history of HIV or hepatitis virus infection.
Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
Patients with impaired kidney function.
Intervention: Propranolol
Trial phase: Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Patients will receive Propranolol in this condition.

Propranolol: 40 mg; Single Administration.
Eligibility criteria:
Inclusion Criteria:

Participants must meet DSM-IV criteria for current alcohol dependence
Participants must have experienced criminal victimization
Use of birth control by female participants
Live within a 50-mile radius of research site
Consent to remain abstinent of all drugs and alcohol for 24 hours prior to patient admission and follow-up
Consent to random assignment to propanol or placebo
Individuals must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.

Exclusion Criteria:

Women who are pregnant, nursing or are of childbearing potential and not using birth control.
Evidence or history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurological disease
Significant liver impairment
Currently taking anti-arrhythmic agents, psychostimulants or other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to propanol
Individuals taking medication that could adversely interact with the study medication, including the following: albuterol, insulin or significant inhibitors of CYP2D6
Individuals with bronchial asthma or chronic obstructive pulmonary disease
Prospective participants will be excluded if they are currently receiving exposure-based therapy for PTSD.
Individuals with a history of or current psychotic disorder.
Individuals with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect cortisol levels.
Individuals receiving synthetic glucocorticoid therapy, any exogenous therapy, or treatment with other agents that interfere with HPA axis function within one month of the time of testing.
Individuals with resting heart rates less than 55 bpm.