anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetylcysteine
Trial phase: Phase 3
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 153
Group description: N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
Eligibility criteria:
Inclusion Criteria:

Age 18-50 years
Must be able to understand the study and provide written informed consent
Must meet current DSM-IV criteria for cannabis dependence in the last 30 days
Must express interest in treatment for cannabis dependence
Must submit a positive urine cannabinoid test during screening
Women of child bearing potential must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring

Exclusion Criteria:

Allergy or intolerance to N-Acetylcysteine
Women who are pregnant or lactating
Current use of NAC or any supplement containing N-Acetylcysteine (must agree not to take any such supplement throughout study participation)
Use of carbamazepine or nitroglycerin within 14 days of randomization
Current enrollment in treatment for cannabis dependence
Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening or during the period between screening and randomization
Current substance dependence, other than cannabis or nicotine
Urine drug screen positive for any drug of abuse other than cannabis or amphetamines at the randomization visit (Only participants who have a valid prescription for amphetamines (e.g., for ADHD) may be included)
Urine drug screen positive for amphetamines at the randomization visit without having a valid prescription for it
Maintenance treatment with buprenorphine or methadone
Recent history of asthma (within the last 3 years)
History of seizure disorder, bipolar disorder, schizophrenia, or other significant or unstable medical or psychiatric illness that may place the participant at increased risk in the judgment of the medical clinician
Significant risk of homicide or suicide
Intervention: Hydromorphone
Trial phase: Phase 2
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 174
Group description: Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Eligibility criteria:
Inclusion Criteria:

English or Spanish speaking
Age 18 - 65 years old
Acute pain (less than 7 days in duration)
Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician

Exclusion Criteria:

Allergy to hydromorphone
Systolic blood pressure < 90 mm Hg
Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen
Alcohol or other drug intoxication as judged by the attending physician
Suspicion of drug seeking by ED physician
Use of opioids within the past 24 hours
Use of a monoamine oxidase inhibitor
Concurrent use of benzodiazepines
Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia)
History of COPD, sleep apnea, renal failure, liver disease
Pregnancy or breast feeding
Prior entry of patient in the study
Inability or unwillingness to provide informed consent
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 438
Group description: Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Eligibility criteria:
Inclusion criteria :

Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
Signed written informed consent.

Exclusion criteria:

HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11% (> 97 mmol/mol)
History of type 2 diabetes mellitus for less than 1 year before screening
Less than 6 months before screening with non-insulin antihyperglycemic treatment
Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening
Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening
Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Prednisone
Trial phase: Phase 4
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Oral steroid medication

Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days

Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study
Eligibility criteria:
Inclusion Criteria:

They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the Taskforce on Rhinosinusitis.
They have a CT-scan in our clinic or have a viewable recent (< 3weeks prior to clinic visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or greater is felt to be indicative of at least moderate CRS.
They do not have nasal polyps on initial clinic nasal endoscopy
They are willing to participate in a clinical study
They are between the ages of 18 to 80.

Exclusion Criteria:

They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
They have been treated with a > 3 week course of antibiotics and/or systemic steroids will also be excluded.
They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
They have nasal polyps on physical exam.
They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
They have a Lund-Mckay score on CT scan of < 6
They are < 18 or > 80 years old
Intervention: Mometasone
Trial phase: Phase 4
ATC code: D07AC13 | R01AD59 | R03AK14 | R03AL12
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Topical steroid medication

Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily

If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead

Antihistamines if an appropriate history of atopy is obtained

Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.
Eligibility criteria:
Inclusion Criteria:

They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the Taskforce on Rhinosinusitis.
They have a CT-scan in our clinic or have a viewable recent (< 3weeks prior to clinic visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or greater is felt to be indicative of at least moderate CRS.
They do not have nasal polyps on initial clinic nasal endoscopy
They are willing to participate in a clinical study
They are between the ages of 18 to 80.

Exclusion Criteria:

They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
They have been treated with a > 3 week course of antibiotics and/or systemic steroids will also be excluded.
They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
They have nasal polyps on physical exam.
They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
They have a Lund-Mckay score on CT scan of < 6
They are < 18 or > 80 years old
Intervention: Bivalirudin
Trial phase: Phase 2
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.

ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.
Eligibility criteria:
Inclusion Criteria:

3.1 Participant Inclusion Criteria 3.1.1 Detectable blood AFB1-albumin adduct levels (limit of detection=0.01 pmol/mg albumin) 3.1.2 18 -85 years 3.1.3 Ability to take oral capsules 3.1.4 Negative urine pregnancy test for women of childbearing age 3.1.5 Must have the ability to understand and the willingness to provide a written informed consent to participate in the study

Exclusion Criteria:

3.2 Participant Exclusion Criteria 3.2.1 History of known allergy to silicates 3.2.2 Pregnancy or lactation 3.2.3 History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up 3.2.4 Any serious systemic disorders incompatible with the study 3.2.5 History of chronic disease (ie heart disease, renal disease). A participant may have a diagnosis of and be managed for diabetes) Any recent diagnosis of cancer.

3.2.6 Participation in any other clinical study where the participant is actively taking an investigational medication within the last 30 days

-
Intervention: Bivalirudin
Trial phase: Phase 2
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.

ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.
Eligibility criteria:
Inclusion Criteria:

3.1 Participant Inclusion Criteria 3.1.1 Detectable blood AFB1-albumin adduct levels (limit of detection=0.01 pmol/mg albumin) 3.1.2 18 -85 years 3.1.3 Ability to take oral capsules 3.1.4 Negative urine pregnancy test for women of childbearing age 3.1.5 Must have the ability to understand and the willingness to provide a written informed consent to participate in the study

Exclusion Criteria:

3.2 Participant Exclusion Criteria 3.2.1 History of known allergy to silicates 3.2.2 Pregnancy or lactation 3.2.3 History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up 3.2.4 Any serious systemic disorders incompatible with the study 3.2.5 History of chronic disease (ie heart disease, renal disease). A participant may have a diagnosis of and be managed for diabetes) Any recent diagnosis of cancer.

3.2.6 Participation in any other clinical study where the participant is actively taking an investigational medication within the last 30 days

-
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
Eligibility criteria:
Inclusion Criteria:

Male adults aged ≥ 40 years with LUTS/BPH, IPSS ≥ 8
Free of active urinary tract infection
Free of neurogenic voiding dysfunction
No history of previous prostate biopsy within 6 months
No treatment of BPH by alpha-blocker or 5-alpha-reductase inhibitor within 6 months
Patient or his legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
Patients with acute r chronic urinary retention and urodynamically proven detrusor underactivity
Patients with postvoid residual > 250 mL

Patients have laboratory abnormalities at screening including:

Aspartate aminotransferase (AST) > 3 x upper limit of normal range
Alanine aminotransferase (ALT) > 3 x upper limit of normal range
Patients have abnormal serum creatinine level > 2 x upper limit of normal range
Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
Patients participated investigational drug trial within 1 month before entering this study
Intervention: Pegunigalsidase-alfa
Trial phase: Phase 1 | Phase 2
SMILES: NC(CCCCNC(=O)CCC(=O)NCCOCCNC(=O)CCC(=O)NCCCCC(N)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: PRX-102 2.0 mg/kg every 2 weeks
Eligibility criteria:
Inclusion Criteria:

Symptomatic adult Fabry patients (≥18 yrs)
Males: plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN in plasma=3.2 nmol/hr/ml, LLN in leucocytes=32 nmol/hr/mg/protein)
Females: historical genetic test results consistent with Fabry mutations
Globotriaosylceramide (Gb3) concentration in urine > 1.5 times upper normal limit
Patients who have never received enzyme replacement therapy (ERT) in the past, or patients who have not received ERT in the past 6 months and have a negative anti alpha galactosidase antibody test
eGFR ≥ 60 mL/min/1.73m2
The patient signs informed consent
Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method

Exclusion Criteria:

Participation in any trial of an investigational drug within 30 days prior to study screening
Chronic kidney disease stages 3-5 (CKD 3-5) (Appendix 7)
History of dialysis or renal transplantation
Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated or dose changed in the 4 weeks prior to screening
Severe myocardial fibrosis by MRI (≥2 late-enhancement [LE] positive left ventricular segments) (Weidemann et al. 2009)
History of clinical stroke
Pregnant or nursing
Presence of HIV and/or HBsAg and/or Hepatitis C infections
Known allergies to ERT
Known allergy to Gadolinium based contrast agents
Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained before any trial-related activities.
Type 1 or type 2 diabetes
Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)
Caucasians

Exclusion Criteria:

Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
Previous participation in this trial. Participation is defined as: screened
Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
Injection of more than 40 units of insulin per injection
Continuous Subcutaneous Insulin Infusion use within the last 6 months
Continuous Glucose Monitoring use within the last 6 months
Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
Known active or in-active skin disease in the injection area or that may affect pain perception
Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: placebo comparator
Eligibility criteria:
Inclusion Criteria:

• Age > 25 years old

Primary osteoarthritis of the knee
Must be undergoing unilateral total knee arthroplasty
Anesthesia assesment score I, II, or III

Exclusion Criteria:

Severe joint malalignment (defined as varus/valgus angle > 20 deg)

Use of gabapentin pre-operatively
History of chronic pain (currently under treatment)
History of substance abuse
Impaired kidney function (defined as creatinine > 1.5)
Epilepsy (currently on medication for treatment)
Known allergy to Gabapentin
Known history of depression or suicidal thoughts and behaviors
Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Active pain control medicine
Eligibility criteria:
Inclusion Criteria:

• Age > 25 years old

Primary osteoarthritis of the knee
Must be undergoing unilateral total knee arthroplasty
Anesthesia assesment score I, II, or III

Exclusion Criteria:

Severe joint malalignment (defined as varus/valgus angle > 20 deg)

Use of gabapentin pre-operatively
History of chronic pain (currently under treatment)
History of substance abuse
Impaired kidney function (defined as creatinine > 1.5)
Epilepsy (currently on medication for treatment)
Known allergy to Gabapentin
Known history of depression or suicidal thoughts and behaviors
Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.