anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydroxyurea
Trial phase: Phase 4
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients with glomerular renal hyperfiltration defined by GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years.
Male or female.
Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (DNA) analysis.
Affiliation to a social security system.
Having freely consented in writing after being informed of the objective, programme and potential risks incurred.

These criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion during the last 6 months before inclusion:

Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men.
Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2.

Glomerular renal hyperfiltration: GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.

Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes.

Exclusion Criteria:

Refusal to consent.
Patients that do not comply.
Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.
Patients having had an exchange transfusion in the 15 days before inclusion in the study.
Patients participating in another clinical trial or in the exclusion period of a previous clinical trial.
Patients treated with a diuretic.
Dialysis patient.
Patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month.
Pregnant or breast-feeding women.
Patients deprived of liberty or under legal protection.
Patients who cannot understand the objective and the course of the study, incapable of giving their consent.
In the event of severe hepatic failure.
In the event of severe renal failure (creatinine clearance < 30 ml/min).
Patients who show toxic signs of bone marrow suppression.
Intervention: Hydroxyurea
Trial phase: Phase 4
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years.
Male or female.
Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (DNA) analysis.
Affiliation to a social security system.
Having freely consented in writing after being informed of the objective, programme and potential risks incurred.

These criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion during the last 6 months before inclusion:

Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men.
Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2.

Glomerular renal hyperfiltration: GFR > 130 mL/min/1.73m2 in women and GFR > 140 mL/min/1.73m2 in men.

Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes.

Exclusion Criteria:

Refusal to consent.
Patients that do not comply.
Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.
Patients having had an exchange transfusion in the 15 days before inclusion in the study.
Patients participating in another clinical trial or in the exclusion period of a previous clinical trial.
Patients treated with a diuretic.
Dialysis patient.
Patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month.
Pregnant or breast-feeding women.
Patients deprived of liberty or under legal protection.
Patients who cannot understand the objective and the course of the study, incapable of giving their consent.
In the event of severe hepatic failure.
In the event of severe renal failure (creatinine clearance < 30 ml/min).
Patients who show toxic signs of bone marrow suppression.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.

Ketamine: intervenous injections
Eligibility criteria:
Inclusion Criteria:

Males/females at least 18 years of age but no older than 65 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
A current depressive episode that has lasted a minimum of 4 weeks.
Have > 3 trials of antidepressants/augmentation strategies.
Have a support system capable of transporting the patient post-treatment.

Exclusion Criteria:

Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.

Midazolam: intervenous injections
Eligibility criteria:
Inclusion Criteria:

Males/females at least 18 years of age but no older than 65 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
A current depressive episode that has lasted a minimum of 4 weeks.
Have > 3 trials of antidepressants/augmentation strategies.
Have a support system capable of transporting the patient post-treatment.

Exclusion Criteria:

Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Mesalamine 4 g extended release granules (sachet), administered orally QD
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18 to 75 years
Mild to moderate UC

Exclusion Criteria:

Disease limited to proctitis <15 cm
Short bowel syndrome
Prior colon resection surgery
History of severe/fulminant UC
Evidence of other forms of inflammatory bowel disease
Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
Intolerant or allergic to aspirin or salicylate derivatives
Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
Women who are pregnant or nursing
History or known malignancy
History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria:

Evidence of other forms of inflammatory bowel disease
Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
Disease limited to proctitis <15 cm
Short bowel syndrome
Prior colon resection surgery
History of severe/fulminant UC
Intolerant or allergic to aspirin or salicylate derivatives
Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
Women who are pregnant or nursing
History of known malignancy
History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Adductor canal catheters: medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery

Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the 2. This level will be marked on the skin. The needle was inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread

ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 min lock
Eligibility criteria:
Inclusion Criteria:

undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for postoperative analgesia following primary tri-compartment knee arthroplasty or foot/ankle surgery;
anticipated to have at least moderate pain following surgery [NRS>3]; and,
age 18 years or older.

Exclusion Criteria:

pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year);
inability to communicate with the investigators and hospital staff;
clinical neuropathy in the surgical extremity;
chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
BMI > 40 kg/m2;
allergy to study medications (lidocaine, ropivicaine);
known renal insufficiency; or,
incarceration.
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Adductor canal catheters: Inserted as described by Manickam et al. 2009

Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected."

ropivacaine 0.2%: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Eligibility criteria:
Inclusion Criteria:

undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for postoperative analgesia following primary tri-compartment knee arthroplasty or foot/ankle surgery;
anticipated to have at least moderate pain following surgery [NRS>3]; and,
age 18 years or older.

Exclusion Criteria:

pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year);
inability to communicate with the investigators and hospital staff;
clinical neuropathy in the surgical extremity;
chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
BMI > 40 kg/m2;
allergy to study medications (lidocaine, ropivicaine);
known renal insufficiency; or,
incarceration.
Intervention: Lorcaserin
Trial phase: Phase 1 | Phase 2
ATC code: A08AA11
SMILES: C[C@H]1CNCCc2ccc(Cl)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.

Lorcaserin: 10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years old
Sepsis [ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or suspected infection]
Muscle weakness [Medical Research Council sum score <48/60 or handgrip strength <11 kg in men and <7 kg in women]
Obey Commands [Score for DeJonghe Awakening Score of ≥3/5]

Exclusion Criteria:

Severe renal insufficiency [Creatinine Clearance <30 mL/min - or receiving dialysis]
Acute infectious or auto-immune hepatitis, acute liver failure or a history of cirrhosis without liver transplant
History of psychosis
Bradycardia, or 2nd or 3rd degree Atrio-Ventricular block without pacemaker
History of valvular heart disease without valve replacement
History of priapism
Pre-existing cognitive impairment
Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be substituted stopped or titrated.
Receiving Sulfonylurea medication at the time of the study
Prior neuromuscular or central nervous system disease, including pre-existing neuropathy
Inability to perform study's muscle strength assessments based on patient's baseline status prior to hospital admission
Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia, or infarction; short gut syndrome)
Body mass index >40
Patient not expected to survive >4 days
Pregnancy or lactation
Allergy to lorcaserin or lorcaserin taken in the prior 7 days
Enrolled in another interventional drug or physical rehabilitation trial
Physician declines for patient to be enrolled
Patient or proxy declines consent
Unable to reach proxy for consent
Non-English speaking
Intervention: Furosemide
Trial phase: Phase 1 | Phase 2
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: 24
Group description: Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration.
Eligibility criteria:
Inclusion Criteria:

Intractable dyspnea at rest or with minimal activity

Exclusion Criteria:

Chronic congestive heart failure
Liver or kidney disease
Systemic lupus erythematosis (SLE)
Receiving potassium supplementation or other indication of hypokalemia
Major psychiatric disorders
Furosemide hypersensitivity
Not mentally competent and/or alert (unable to grant informed consent)
Under 18 years old
Not fluent in English
Inadequate birth control
Intervention: Cenestin
Trial phase: Not Applicable
SMILES: CC12CCC3C(=CCc4cc(OS(=O)(=O)[O-])ccc43)C1CCC2=O.[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks

Estrogen Cream: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Overactive bladder
Clinical diagnosis of Postmenopausal:
English language skills sufficient to complete questionnaires
Clinical indication for vaginal estrogen use
Not currently receiving vaginal estrogen therapy

Exclusion Criteria:

Currently on systemic hormone replacement therapy (HRT) Have been on HRT within the past three months
Clinical diagnosis of estrogen dependent malignancies
Allergy to local estrogen therapy
Insufficient language skills to complete study questionnaires
Women with active, urinary tract infection
Received antibiotics within the past two weeks
Clinical diagnosis of stage 3 or 4 pelvic organ prolapse
Patient unwilling to use vaginal estrogen preparation
Currently on anticholinergic medication Have received anticholinergic medication within the past three months
Previously failed two medications for treatment of OAB Previously received intra-vesicle botulinum toxin injections Previously had posterior tibial nerve stimulation Previously had implantation of sacral neuromodulator
Patients wishing to start anticholinergic medication at the initial encounter
Undiagnosed abnormal genital bleeding
Clinical diagnosis of deep vein thrombosis (DVT) Clinical diagnosis of pulmonary embolism (PE)
Clinical diagnosis of arterial thromboembolic disease
Clinical diagnosis of liver dysfunction or disease
Clinical diagnosis of protein C, protein S or antithrombin or deficiency other known thrombophilic disorders
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)
Eligibility criteria:
Inclusion Criteria:

Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.

Exclusion Criteria:

Patients under the age of 18, or over the age of 79
Allergy to local anesthetics or corticosteroids
Patients with history of chronic pain or with chronic use of opioid analgesics
Patients with history of lung disease or prior anterior thoracotomy or median sternotomy
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.

Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.

0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.

(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Eligibility criteria:
Inclusion Criteria:

Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.

Exclusion Criteria:

Patients under the age of 18, or over the age of 79
Allergy to local anesthetics or corticosteroids
Patients with history of chronic pain or with chronic use of opioid analgesics
Patients with history of lung disease or prior anterior thoracotomy or median sternotomy
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: DFD01 spray, twice daily, 15 days

DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Eligibility criteria:
Inclusion Criteria:

Subjects must weigh at least 55 pounds
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Have received treatment for any type of cancer within 5 years of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
Subjects who have an abnormal sleep schedule or work overnight.
Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.