anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Idebenone
Trial phase: Phase 2
ATC code: N06BX13
SMILES: COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Idebenone 900 mg/day

Idebenone: 900 mg/day for 1 month
Eligibility criteria:
Inclusion Criteria:

Diagnosis of MELAS with confirmed A3243G mtDNA mutation, or evidence of central nervous system involvement (cognitive problems, migraines, memory loss)
Cerebral lactate level equal to or greater than 5.0 i.u. at baseline
Patients at least 8 and < 65 years of age at baseline
Patients with a body weight > 37 kg/82 lbs at baseline
Stable co-medication/vitamins/supplements within 1 month prior to baseline
Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the study medication
Negative urine pregnancy test at screening and baseline (female patients of childbearing potential)

Exclusion Criteria:

Contraindication to MRS (e.g. metal implant, claustrophobia)
Stroke like event within 2 months prior to baseline
Treatment with idebenone at any dose, or coenzyme Q10 at doses above 100mg/d within 1 month prior to baseline
Inadequate contraception use
Pregnancy and/or breast-feeding
Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine
Current abuse of drugs or alcohol
Participation in a trial of another investigational drug within the last month
Other factor that, in the investigator's opinion, excludes the patient from entering the study
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Eligibility criteria:
Inclusion Criteria:

ASA I-III
Ages 18-65 years
Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
Surgery expected to last more than one hour
Patient expected to have moderate to severe post-operative pain
Patient refused regional anesthesia or has a contraindication to regional anesthesia

Exclusion Criteria:

Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
Difficulty or inability to understand the study or protocol
Known renal or hepatic dysfunction
BMI> 35
Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
Pregnancy
Taking preoperative opioids for more than 2 weeks before the surgery
Intervention: Deferoxamine
Trial phase: Phase 2
ATC code: V03AC01
SMILES: CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Treatment with Deferasirox (Exjade) and Deferoxamine (DFO) with dosing based on baseline iron overload.
Eligibility criteria:
Inclusion Criteria:

Transfusion Dependent Thalassemia
If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
Older than 8 years

Exclusion Criteria:

Participating on another interventional clinical trial
Intervention: Efavirenz
Trial phase: Phase 2
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
Eligibility criteria:
Inclusion Criteria:

Documented HIV-1 infection
In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection
Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection
HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)
Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening

Exclusion Criteria:

Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance
Known infection with HIV-2 or with HIV-1 group O
Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive
Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured
Specific grade 3 or 4 laboratory abnormalities
Intervention: Idebenone
Trial phase: Phase 3
ATC code: N06BX13
SMILES: COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day

idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
Eligibility criteria:
Inclusion Criteria:

Documented diagnosis of FRDA with confirmed FRDA mutations
Patients 8 years of age or older at baseline
Patients with body weight ≥ 25kg
Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the medication
Negative urine pregnancy test at screening and at baseline (women of childbearing potential)

Exclusion Criteria:

Treatment with idebenone or Coenzyme Q10 within the past 1 month
Pregnancy and/or breast-feeding
Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
Past or present history of abuse of drugs or alcohol
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele
Forced expiratory volume in 1 second (FEV1) of 40% to 90% (inclusive) of predicted normal for age, gender, and height at Screening.
No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator
Willing to use highly effective birth control methods during the study

Exclusion Criteria:

History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
History of alcohol, medication or illicit drug abuse within one year prior to Day 1
Abnormal liver function ≥ 3x the upper limit of normal
Abnormal renal function at Screening
History of solid organ or hematological transplantation
Pregnant, planning a pregnancy, breast-feeding, or unwilling to follow contraception requirements
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening
Use of inhaled hypertonic saline treatment
Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)
Intervention: Ivacaftor
Trial phase: Phase 3
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
Eligibility criteria:
Inclusion Criteria:

Weighing at least 15 kg
Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele
Forced expiratory volume in 1 second (FEV1) of 40% to 105% (inclusive) of predicted normal for age, gender, and height (Knudson standards) at Screening
Able to swallow tablets
As judged by the investigator, parent or legal guardian and subject must have been able to understand protocol requirements, restrictions, and instructions, and the parent or legal guardian should have been able to ensure that the subject complied with, and was likely to complete, the study as planned
Parent or legal guardian must have signed the informed consent form and corresponding assent must be obtained from the subject
Willing to use at least 1 highly effective birth control method during the study
No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator

Exclusion Criteria:

History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
Abnormal liver function ≥ 3x the upper limit of normal
Abnormal renal function at Screening
History of solid organ or hematological transplantation
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening
Use of inhaled hypertonic saline treatment
Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)
Intervention: Fesoterodine
Trial phase: Phase 4
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 463
Group description: Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
Eligibility criteria:
Inclusion Criteria:

Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
Be male or female above the age of 18
Female patients who no longer have child-bearing potential

Women of Child-Bearing Potential(WOCBP) who:

are not pregnant and have been using an adequate and medically approved method of contraception
have a negative urine pregnancy test
Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

Women who are pregnant or lactating
Known hypersensitivity or contraindication to or greater heart block
Previous heart transplant
Known right-to-left shunt (including atrial septal defect)
Severe pulmonary artery hypertension (i.e., > 75 mmHg
Current uncontrolled ventricular tachycardia
Second-degree or greater heart block
Any contraindications for the use of a right heart catheter
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Methadone administration 0.1mg/kg

Methadone: Subjects will receive methadone as their intraoperative opioid.
Eligibility criteria:
Inclusion Criteria:

Age 5-18
Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria:

History of or known liver or kidney disease
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Methadone administration 0.2mg/kg

Methadone: Subjects will receive methadone as their intraoperative opioid
Eligibility criteria:
Inclusion Criteria:

Age 5-18
Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria:

History of or known liver or kidney disease
Intervention: Xylitol
Trial phase: Not Applicable
SMILES: OC[C@@H](O)[C@H](O)[C@@H](O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse
Eligibility criteria:
We now have two arms to this study.

Group I: Immunocompetent subjects with chronic rhinosinusitis

Inclusion Criteria:

56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

Anterior and/or posterior mucopurulent drainage
Nasal obstruction
Facial pain, pressure, and/or fullness
Decreased sense of smell
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion Criteria:

Cystic fibrosis
Fungal sinusitis
Immunocompromised status (use of long term oral steroids (> 30 days), AIDS, active malignancy or chemotherapy)
Known Ciliary disorders
Sinonasal tumors
Pregnancy

Group 2: CRS with antibody deficiency

56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

Anterior and/or posterior mucopurulent drainage
Nasal obstruction
Facial pain, pressure, and/or fullness
Decreased sense of smell
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion criteria:

Cystic Fibrosis Sinonasal tumors Pregnancy
Intervention: Permethrin
Trial phase: Phase 3
ATC code: P03AC04 | P03AC54
SMILES: CC1(C)C(C=C(Cl)Cl)C1C(=O)OCc1cccc(Oc2ccccc2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: Nix applied to scalp for 10 minutes

Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
Eligibility criteria:
Inclusion Criteria:

Confirmed active head lice infestation

Exclusion Criteria:

Allergy to pediculicides or hair care products
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Current antibiotic treatment
Intervention: Xylitol
Trial phase: Phase 1 | Phase 2
SMILES: OC[C@@H](O)[C@H](O)[C@@H](O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 5 ml of 15% xylitol twice daily

Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)
Eligibility criteria:
Inclusion Criteria:

Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
Age 12 or greater
FEV1 > 30% predicted(within the last 14 days and oxygen saturation > 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
Admitted for an exacerbation,
Use of effective contraception in women,
Able to provide written informed consent.

Exclusion Criteria:

Pregnancy,
History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
Hemoptysis more than 60 mL within the last 30 days,
Use of any investigational study drug within the last 30 days,
Initiation of hypertonic saline within the last 30 days,
A serum creatinine 2 mg/dl or more
Active malignancy in the last year
Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
B cepacia colonization
Waiting list for lung transplant
Lack of FEV1 data from the last 14 days
Previous participation in this study
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Women with newly diagnosed early invasive breast cancer will receive Metformin

Metformin: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
Eligibility criteria:
Inclusion Criteria:

Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
Body mass index > 25
Age ≥ 21 years
No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
Signed informed consent

Exclusion Criteria:

History of diabetes mellitus requiring medical therapy
Treatment with other investigational drugs within 6 months of study entry
Significant renal impairment with a creatinine > 1.4 mg/dl
Other serious intercurrent medical illness
Intervention: Sirolimus
Trial phase: Phase 4
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 5 mg, PO , daily

Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Eligibility criteria:
Inclusion Criteria:

Age => 18.
Recipient of a deceased donor kidney transplant.
Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis
Stable serum creatinine for 2 weeks prior to enrollment.
Able to give informed consent.
Compliant with medical regimen and clinic visits.

Exclusion Criteria:

Episode of acute rejection within 4 weeks prior to enrollment.
Calculated GFR < 30 ml/min.
Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).
Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.
Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.
Recipient of pancreas or liver allografts.
Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.
Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.
Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.
Unwilling to comply with study protocol.
Enrollment in another drug trial that precludes use of sirolimus.
Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
For women, pregnancy.
Allergy to iodine
Intervention: AZD2066
Trial phase: Phase 2
SMILES: C[C@@H](Oc1nnc(-c2ccncc2)n1C)c1cc(-c2cccc(Cl)c2)on1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: AZD2066, 12 mg capsule
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Male or non-fertile females
Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria:

Other pain that may confound assessment of neuropathic pain.
Diagnosis of any severe neurological disease.
History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.