anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM FLUORIDE
Trial phase: Phase 3
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Eligibility criteria:
Inclusion Criteria:

Age:Age 18 through 65 years.
General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination, specifically including diabetes or hypoglycemia.
Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.

Exclusion Criteria:

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
Breast-feeding:Women who are breast-feeding.
Medical History:Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit 1 at the start of the study with the exception of those participating in GSKCH study Z3170476.
Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning.
Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse.
Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
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: 151
Group description: Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
Eligibility criteria:
Inclusion criteria:

Subjects and their caregivers must provide informed consent prior to study entry.
Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with a documented 6-month history of AD symptoms
Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
Female subjects of child-bearing potential must agree to pregnancy testing and approved form of birth control.

Exclusion criteria:

Diagnosis of possible, probable or definite vascular dementia.
History/evidence of any other CNS disorder that could be interpreted as a cause of dementia
History of known or suspected seizures, loss of consciousness or significant head trauma
Subjects with ECG, blood pressure and laboratory values outside of protocol criteria are excluded.
Subjects with known photosensitivity
Subjects with a history of previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.
Intervention: Apremilast
Trial phase: Phase 1 | Phase 2
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Eligibility criteria:
Inclusion Criteria:

Diagnosis of cutaneous discoid lupus by clinical and histopathological exam

Exclusion Criteria:

Systemic lupus involving the internal organs
Systemic vasculitis
History of other clinically significant disease process
History of HIV, hepatitis B or C
Concurrent use of immune modulating therapy
Evidence of incompletely treated tuberculosis
Pregnant or lactating female
Intervention: Maraviroc
Trial phase: Not Applicable
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
On ART for at least 48 weeks prior to study entry with a regimen that includes three or more antiretroviral medications
No change in ART regimen for at least 24 weeks prior to study entry
Screening CD4+ T-cell count less than 250 obtained within 60 days prior to study entry
Stable CD4+ T-cell count for at least 48 weeks prior to study entry (as assessed by an estimated CD4+ T-cell count slope between -20 and +20 cells/year)
Screening HIV-1 RNA below the limit of detection using an FDA-approved assay obtained within 60 days prior to study entry
All other plasma HIV-1 RNA measurements in the 48 weeks prior to study entry must be below the limit of detection

Laboratory values obtained within 60 days prior to study entry:

Absolute neutrophil count (ANC) >=750/µL
Hemoglobin >=9.0 g/dL for female subjects and >=10.0 g/dL for male subjects
Platelet count >=50,000/ µL
Calculated creatinine clearance (CrCl) >=30 mL/min
Aspartate aminotransferase (serum glutamic oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), and alkaline phosphatase <=5 X Upper Limit of Normal (ULN)
Direct bilirubin <=2.5 X ULN
Females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to study entry
Agree not to participate in the conception process, and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives while receiving study treatment and for 6 weeks after stopping study treatment.

Exclusion Criteria:

Unstable clinical condition
Currently breast-feeding or pregnant
Use of immunomodulators or cancer chemotherapy or radiation treatment within 12 months prior to study entry
An acute AIDS-defining illness within 60 days prior to study entry
Known allergy/sensitivity or hypersensitivity to components of MVC, including allergy or hypersensitivity to soya lecithin, soya or peanuts
Active drug or alcohol abuse that, in the opinion of the investigator, would interfere with adherence to study regimens
Serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry
Receipt of a vaccine within 30 days prior to study entry
Current or previous use of a CCR5 inhibitor
Plan to change background ART regimen within 24 weeks after study entry
Receipt of experimental or non-experimental medications for the purpose of raising CD4+ T-cell counts within 6 months prior to study entry
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SLE by American College of Rheumatology (ACR) criteria
Serum 25-OH vitamin D level of 20 ng/mL or less
Stable disease at screening, defined as a modified Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) of 4 or less
Interferon (IFN) signature present. More information about this criterion can be found in the protocol
Positive anti-double-stranded (anti-ds) DNA antibody blood test at screening
If on corticosteroids, the dose must be less than 20 mg per day and stable for 4 weeks prior to screening and at study entry
If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must be stable for 3 months prior to screening and at study entry
If receiving a multivitamin or a vitamin D supplement, the dose of vitamin D must be 800 IU daily or less and stable for the 3 months prior to screening and at study entry
Agree to use effective contraceptive methods for the duration of the study

Exclusion Criteria:

Unwilling to stop using drugs or substances that may interfere with fat absorption
Hypercalcemia
Hypercalciuria
History of hyperparathyroidism
History of kidney stones
History of cancer, except cervical carcinoma in situ and resected basal and squamous cell carcinomas of the skin
Known history of chronic viral infections, including human immunodeficiency virus (HIV), Hepatitis B, and Hepatitis C
Known active tuberculosis
Any British Isles Lupus Assessment Group (BILAG) A or B manifestation with the exception of a BILAG B mucocutaneous manifestation
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver function tests greater than or equal to two times the upper limit of normal
Dialysis or serum creatinine greater than 1.5 mg/dL
Expectation by the investigator to increase corticosteroid or immunosuppressive or immunomodulatory medication dose at screening, study entry, or over the course of the study
Treatment with cyclophosphamide within 3 months of screening
Treatment with rituximab within 12 months of screening
Other investigational drug and or treatment during the 4 weeks or seven half lives of the other investigational drug prior to study entry
Drug or alcohol abuse within 6 months prior to study entry
Treatment with digoxin
Treatment with teriparatide
Any condition that, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
Pregnant or breastfeeding
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SLE by American College of Rheumatology (ACR) criteria
Serum 25-OH vitamin D level of 20 ng/mL or less
Stable disease at screening, defined as a modified Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) of 4 or less
Interferon (IFN) signature present. More information about this criterion can be found in the protocol
Positive anti-double-stranded (anti-ds) DNA antibody blood test at screening
If on corticosteroids, the dose must be less than 20 mg per day and stable for 4 weeks prior to screening and at study entry
If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must be stable for 3 months prior to screening and at study entry
If receiving a multivitamin or a vitamin D supplement, the dose of vitamin D must be 800 IU daily or less and stable for the 3 months prior to screening and at study entry
Agree to use effective contraceptive methods for the duration of the study

Exclusion Criteria:

Unwilling to stop using drugs or substances that may interfere with fat absorption
Hypercalcemia
Hypercalciuria
History of hyperparathyroidism
History of kidney stones
History of cancer, except cervical carcinoma in situ and resected basal and squamous cell carcinomas of the skin
Known history of chronic viral infections, including human immunodeficiency virus (HIV), Hepatitis B, and Hepatitis C
Known active tuberculosis
Any British Isles Lupus Assessment Group (BILAG) A or B manifestation with the exception of a BILAG B mucocutaneous manifestation
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver function tests greater than or equal to two times the upper limit of normal
Dialysis or serum creatinine greater than 1.5 mg/dL
Expectation by the investigator to increase corticosteroid or immunosuppressive or immunomodulatory medication dose at screening, study entry, or over the course of the study
Treatment with cyclophosphamide within 3 months of screening
Treatment with rituximab within 12 months of screening
Other investigational drug and or treatment during the 4 weeks or seven half lives of the other investigational drug prior to study entry
Drug or alcohol abuse within 6 months prior to study entry
Treatment with digoxin
Treatment with teriparatide
Any condition that, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
Pregnant or breastfeeding
Intervention: Nicotine
Trial phase: Phase 2
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 195
Group description: Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum
Eligibility criteria:
Inclusion Criteria:

smoking at least 10 cigarettes daily for the past year,
in good physical health (no unstable medical condition;
no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
Intervention: Leptin
Trial phase: Phase 1 | Phase 2
SMILES: CSCCC(N=C(O)C(CC(=O)O)N=C(O)C(CCC(=N)O)N=C(O)C(CC(C)C)N=C(O)C(CO)N=C(O)CN=C(O)C(CCC(=N)O)N=C(O)C(N)CC(C)C)C(O)=NC(CC(C)C)C(O)=NC(Cc1c[nH]c2ccccc12)C(O)=NC(CCC(=N)O)C(O)=NC(CC(C)C)C(O)=NC(CC(=O)O)C(O)=NC(CC(C)C)C(O)=NC(CO)C(=O)N1CCCC1C(O)=NCC(O)=NC(CS)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: This group "Leptin Intervention" inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only.
Eligibility criteria:
Inclusion Criteria:

Women ages 25-65 years who are 18 months to 15 years Roux-en-Y gastric bypass
Current BMI of 28-50 kg/m2 and a percent total body weight loss from highest pre-surgical weight of >20% and <45%
Must live in the vicinity of New York City to comply with 11 study visits over 34 weeks
Must be willing to self-inject study drug twice per day

Exclusion Criteria:

Diabetes
History of plastic surgery
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: modafinil 100 milligrams oral dose
Eligibility criteria:
Inclusion Criteria:

adults age 18-54
diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
able to provide informed consent

Exclusion Criteria:

history of significant head injury or other neurological illness
active psychiatric illness requiring significant acute care
significant intellectual impairment (e.g. standardized full-scale IQ < 70)
history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
significant active substance abuse
active pregnancy
active treatment with medications that have drug interactions with modafinil
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: modafinil 200 mg oral dose
Eligibility criteria:
Inclusion Criteria:

adults age 18-54
diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
able to provide informed consent

Exclusion Criteria:

history of significant head injury or other neurological illness
active psychiatric illness requiring significant acute care
significant intellectual impairment (e.g. standardized full-scale IQ < 70)
history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
significant active substance abuse
active pregnancy
active treatment with medications that have drug interactions with modafinil
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: modafinil 400 mg oral dose
Eligibility criteria:
Inclusion Criteria:

adults age 18-54
diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
able to provide informed consent

Exclusion Criteria:

history of significant head injury or other neurological illness
active psychiatric illness requiring significant acute care
significant intellectual impairment (e.g. standardized full-scale IQ < 70)
history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
significant active substance abuse
active pregnancy
active treatment with medications that have drug interactions with modafinil
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Single oral placebo capsule
Eligibility criteria:
Inclusion Criteria:

adults age 18-54
diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
able to provide informed consent

Exclusion Criteria:

history of significant head injury or other neurological illness
active psychiatric illness requiring significant acute care
significant intellectual impairment (e.g. standardized full-scale IQ < 70)
history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
significant active substance abuse
active pregnancy
active treatment with medications that have drug interactions with modafinil
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
Eligibility criteria:
Inclusion criteria:

Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.
Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.
Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.
Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.
Women under the age of 60 with a Gail model score of 1.6% or more are eligible.
Subjective report of at least one daily hot flash.
Able to provide voluntary informed consent.
≥ 18 years-old. There will be no upper limit for age inclusion.
Karnofsky performance status > 70%.
Women with a history of breast cancer must have undergone treatment with curative intent.
≥ 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.
adequate hematopoietic function (ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL)
adequate renal and hepatic function [Bilirubin ≤ 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5x ULN, Alkaline phosphatase ≤ 2.5x ULN, and Creatinine ≤ 2x ULN].
No clinical evidence of disease (complete remission).
Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.
Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.
Patients must have access to a compact disk player.

Exclusion criteria:

History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).
Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.
Unable to give informed consent or unable to adhere to protocol.
Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.
Any history of alcohol or drug abuse.
Allergy to gabapentin.
History of seizure disorder.