anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sodium phenylacetate and sodium benzoate
Trial phase: Phase 2
ATC code: A16AX30
SMILES: O=C([O-])Cc1ccccc1.O=C([O-])c1ccccc1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
Eligibility criteria:
Inclusion Criteria:

Male or female between the ages of 18 and 75 years
Signed written informed consent by subject's representative
Current diagnosis of chronic liver disease with cirrhosis
West Haven score of Grade 3 or 4 Hepatic Encephalopathy
Weight between 45 and 150 kg
Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory
Estimated creatinine clearance of > 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine < 2.5 mg/dL [Cockcroft-Gault formula: creatinine clearance = (140 - age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females]
Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is < 50 mL/min/1.73 m²
Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal

Exclusion Criteria:

Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours
Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed)
Current diagnosis of acute hepatic failure
Alcohol ingestion during last 24 hours
Post liver transplant
Serum sodium < 120 mEq/L
Serum potassium ≤ 3.5 mEq/L
Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours
Use of any sedatives, benzodiazepines, or any neuro- or psycho-active drugs in the last 6 hours and a positive urinary drug screen
Subjects who received any mind-altering agents (such as barbiturates, propofol, opioids, or benzodiazepines) to assist with intubation are not eligible while the effects of the drug are still apparent
Congestive heart failure (New York Heart Association Class III or IV)
Seizures, dementia, or any neurologic or psychiatric condition within the last 72 hours that may interfere with the assessment of the mental state
Current diagnosis of major aspiration pneumonia or pulmonary edema accompanied by an oxygen saturation of ≤ 90% while breathing supplemental oxygen
Laboratory test abnormalities determined to be clinically significant by the investigator
Enrollment in another experimental (interventional) protocol within the last 30 days or 5 half-lives of the experimental drug, whichever s longer
Any medical condition, which in the opinion of the investigator would constitute a contraindication to enrollment in the study
Intervention: Sodium phenylacetate and sodium benzoate
Trial phase: Phase 2
ATC code: A16AX30
SMILES: O=C([O-])Cc1ccccc1.O=C([O-])c1ccccc1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
Eligibility criteria:
Inclusion Criteria:

Male or female between the ages of 18 and 75 years
Signed written informed consent by subject's representative
Current diagnosis of chronic liver disease with cirrhosis
West Haven score of Grade 3 or 4 Hepatic Encephalopathy
Weight between 45 and 150 kg
Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory
Estimated creatinine clearance of > 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine < 2.5 mg/dL [Cockcroft-Gault formula: creatinine clearance = (140 - age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females]
Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is < 50 mL/min/1.73 m²
Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal

Exclusion Criteria:

Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours
Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed)
Current diagnosis of acute hepatic failure
Alcohol ingestion during last 24 hours
Post liver transplant
Serum sodium < 120 mEq/L
Serum potassium ≤ 3.5 mEq/L
Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours
Use of any sedatives, benzodiazepines, or any neuro- or psycho-active drugs in the last 6 hours and a positive urinary drug screen
Subjects who received any mind-altering agents (such as barbiturates, propofol, opioids, or benzodiazepines) to assist with intubation are not eligible while the effects of the drug are still apparent
Congestive heart failure (New York Heart Association Class III or IV)
Seizures, dementia, or any neurologic or psychiatric condition within the last 72 hours that may interfere with the assessment of the mental state
Current diagnosis of major aspiration pneumonia or pulmonary edema accompanied by an oxygen saturation of ≤ 90% while breathing supplemental oxygen
Laboratory test abnormalities determined to be clinically significant by the investigator
Enrollment in another experimental (interventional) protocol within the last 30 days or 5 half-lives of the experimental drug, whichever s longer
Any medical condition, which in the opinion of the investigator would constitute a contraindication to enrollment in the study
Intervention: Busulfan
Trial phase: Phase 2
ATC code: L01AB01
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Infusion of autologous cluster of differentiation (CD)34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
Eligibility criteria:
Inclusion Criteria:

ADA-SCID with no HLA-identical sibling donor available
pediatric age and at least one of the following criteria:
inadequate immune response after PEG-ADA for > 6 months
patients who discontinued PEG-ADA due to intolerance, allergy or auto-immunity
patients for whom enzyme replacement therapy is not a life long therapeutic option

Exclusion Criteria:

HIV infection
history or current malignancy
Patients who received a previous gene therapy treatment in the 12 months prior to receiving Strimvelis
any other conditions dangerous for the patients according to the investigator
Intervention: Donepezil
Trial phase: Phase 2
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Eligibility criteria:
Inclusion criteria:

Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Patients who have completed Phase II double-blind study (E2020-J081-431).
Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Exclusion criteria:

Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or who underwent brain surgery causing unsolved deficiency.
Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.

0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery
Eligibility criteria:
Inclusion Criteria:

Age 18 - 60
Both sexes
Any race
Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One
Meeting all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Exclusion Criteria:

Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or Hepatitis B or C.
Failure to meet all established criteria for appropriateness for LASIK established by MCG/Eye Care One
Intervention: Apaziquone
Trial phase: Phase 3
SMILES: Cn1c(/C=C/CO)c(CO)c2c1C(=O)C=C(N1CC1)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 402
Group description: Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT
Eligibility criteria:
Inclusion Criteria:

All of the following questions must be answered "Yes" in order for the patient to participate in the study.

Has the patient given written informed consent?
Is the patient at least 18 years old?
Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2?
If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
Is the patient willing and able to abide by the protocol?

Exclusion Criteria:

All of the following questions must be answered "No" in order for the patient to participate in the study.

Does the patient have more than 5 bladder tumors?
Does any single bladder tumor exceed 3.5 cm in diameter?
Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer?
Has the patient ever received EOquin(r)?
Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
Does the patient have an active urinary tract infection?
Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L?
Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L?
Does the patient have a known immunodeficiency disorder?
Has the patient received any investigational treatment within the past 30 days?
Is the patient breast feeding?
Does the patient have a history of interstitial cystitis?
Does the patient have a history of allergy to red color food dye?
Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
Intervention: Adapalene
Trial phase: Phase 3
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 533
Group description: once a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with Moderate or Severe Acne Vulgaris,
20-50 papules and pustules in total on the face excluding the nose
30-100 non-inflammatory lesions on the face excluding the nose.
Negative urine pregnancy test for all females.

Exclusion Criteria:

Subjects with more than one acne nodule.
Subjects with any acne cyst on the face.
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
Subjects who are pregnant, nursing, or planning a pregnancy.
Intervention: Timbetasin acetate
Trial phase: Phase 2
SMILES: CC(=O)O.CCC(C)C(NC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CCSC)NC(=O)C(CC(=O)O)NC(=O)C1CCCN1C(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(Cc1ccccc1)C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CCC(N)=O)C(=O)NC(C)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)O)C(C)CC)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
Eligibility criteria:
Inclusion Criteria

Type 1 or Type 2 diabetes mellitus.
Patients who have an expected minimum 50% likelihood of requiring corneal epithelial debridement in the opinion of the Investigator Size of wound should be 8 mm.
Signed written informed consent by patient or legal guardian.

Exclusion Criteria

Have current or history of herpetic eye disease in the past 3 years.
Display evidence of keratitis.
Have Sjögren's syndrome.
Have corneal scarring, opacity, or dystrophy.
Have a history of malignancy.
Have a history of HIV or AIDs
Are pregnant or lactating females.
Are females who can become pregnant.
Have a known hypersensitivity to the study drug.
May be regarded as unreliable for the study.
Have previously participated in this study.
Experience any complication during the vitrectomy procedure itself, which will exclude the patient from participating in this study.
Intervention: Azithromycin
Trial phase: Phase 1 | Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
Eligibility criteria:
Inclusion Criteria:

Infants weighing <1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria:

Severe respiratory distress syndrome with survival unlikely >7 days, Congenital malformations
Intervention: Deferasirox
Trial phase: Phase 3
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
Eligibility criteria:
Inclusion Criteria:

diagnosis of Porphyria Cutanea Tarda based on clinical exam and 24-hour urine porphyrin levels
have Porphyria Cutanea Tarda for at least 3 months prior to enrollment with active blistering (3 blisters or erosions per month)
women of childbearing potential must use an effective method of contraception during the study, however this cannot include hormonal contraception (oral contraceptives, hormone patches, Depo-Provera injections, NUVA Ring, etc.)
treatment naive patients or patients unresponsive or intolerant of phlebotomy
Ferritin level is greater than or equal to 25ng/mL

Exclusion Criteria:

patients with serum creatinine above the upper limit of normal
patients receiving phlebotomy who are controlled on this therapy
pregnant or breast feeding females
patients with liver transaminases more than 5 times the upper limit of normal
patients with a history of hypersensitivity to deferasirox
patients with a history of pre-existing renal condition, or receiving medication that depresses renal function
patients on other chelators
history of non-compliance to medical regimens.
Intervention: Adapalene
Trial phase: Phase 3
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 535
Group description: once a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with Moderate or Severe Acne Vulgaris,
20-50 papules and pustules in total on the face excluding the nose
30-100 non-inflammatory lesions on the face excluding the nose.
Negative urine pregnancy test for all females.

Exclusion Criteria:

Subjects with more than one acne nodule.
Subjects with any acne cyst on the face.
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
Subjects who are pregnant, nursing, or planning a pregnancy.
Intervention: Thalidomide
Trial phase: Phase 3
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Thalidomide : thalidomide 50 - 100 mg by mouth daily
Eligibility criteria:
Inclusion Criteria:

Idiopathic pulmonary fibrosis for >3 months <5 years
High resolution CT scan of chest consistent with IPF within the previous 12 months
FVC > 40% and < 90% predicted, TLC >40% <80%, DLCo >30% <90%
Chronic Cough - cough >8 weeks
Age >50
Non-child bearing potential

Exclusion Criteria:

Pregnant or lactating women
Women of child bearing potential
Known etiology of lung fibrosis other than IPF
Significant respiratory toxin exposure
Collagen Vascular Disease
Use of narcotic anti-cough agent in last week
significant peripheral vascular disease or neuropathy
history of seizures
poorly controlled diabetes
allergy to thalidomide
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: 402
Group description: Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
Eligibility criteria:
Inclusion Criteria:

Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Exclusion Criteria:

Patients with a baseline SWN-K total score of >75
Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.
Intervention: Linagliptin
Trial phase: Phase 3
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: Patients randomized to receive treatment with matching placebo
Eligibility criteria:
Inclusion criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
Diagnosis of type 2 diabetes prior to informed consent

Glycosylated haemoglobin A1 (HbA1c)at screening:

For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
Age 18 -80 years
BMI (Body Mass Index) less than 40 kg/m2
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent

Pre-menopausal women who:

are nursing or pregnant,
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance