anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 116
Group description: One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.

Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Eligibility criteria:
Inclusion Criteria:

18-65 years old
regular smoker for at least one year
currently smoking 10 or more cigarettes per day

Exclusion Criteria:

Current Axis I disorder
Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
Current suicidal risk
Pregnancy or breast feeding
Use of nicotine replacement products or bupropion
Intervention: Thalidomide
Trial phase: Phase 1 | Phase 2
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: Male
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
Eligibility criteria:
Inclusion Criteria:

Refractory Epilepsy, males

Exclusion Criteria:

Females, peripheric neuropathy
Intervention: Guaifenesin
Trial phase: Not Applicable
ATC code: R05CA03
SMILES: COc1ccccc1OCC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: One 400 milligrams (mg) immediate release tablet administered orally as a single dose
Eligibility criteria:
Inclusion Criteria:

Male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration;
Subjects currently have acute cough self-rated as at least moderate due to an acute Upper Respiratory Infection (URTI) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician's assistant;
Subjects who have > 5 cough bouts during the 30 minute baseline assessment period

Exclusion Criteria:

Subjects who have acute, subchronic, or chronic cough due to any condition other than a URTI as established by the Investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and Gastroesophageal Reflux Disease (GERD) (N.B. Subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment)
In the opinion of a study physician, nurse practitioner, or physician's assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis;
Subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (Note: One "drink" of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);
Intervention: Acetylcysteine
Trial phase: Phase 2
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: 35
Group description: N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)

N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-65;
Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration

Exclusion Criteria:

Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
History of seizures;
Myocardial infarction within 6 months;
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);
Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
Current or recent (past 3 months) DSM-IV substance abuse or dependence;
Illegal substance use within 2 weeks of study initiation;
Initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months prior to study baseline for the treatment of pathologic skin picking;
Previous treatment with N-acetyl cysteine;
Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
Asthma (given possible worsening of asthma due to NAC)
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 231
Group description: Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
Eligibility criteria:
Inclusion Criteria:

Patients for elective offpump coronary artery bypass surgery

Exclusion Criteria:

A history of bleeding disorders
Active chronic hepatitis or cirrhosis
Chronic renal insufficiency (serum creatinine > 2 mg/dL)
Preoperative anemia (Hb < 10 g/dL)
Previous cardiac surgery
Myocardial infarction < 7 days before surgery
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 231
Group description: The placebo consisted of an equivalent volume of saline solution.
Eligibility criteria:
Inclusion Criteria:

Patients for elective offpump coronary artery bypass surgery

Exclusion Criteria:

A history of bleeding disorders
Active chronic hepatitis or cirrhosis
Chronic renal insufficiency (serum creatinine > 2 mg/dL)
Preoperative anemia (Hb < 10 g/dL)
Previous cardiac surgery
Myocardial infarction < 7 days before surgery
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: bimatoprost ophthalmic sterile solution 0.005%
Eligibility criteria:
Inclusion Criteria:

Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

Any eye disease or abnormality
Any permanent eyeliner or eyelash implants of any kind
Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
Any use of prescription eyelash growth products
Any use of over the counter eyelash growth products during the 6 months prior to baseline
Any use of treatments that may affect hair growth during the 6 months prior to baseline
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: bimatoprost ophthalmic sterile solution 0.015%
Eligibility criteria:
Inclusion Criteria:

Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

Any eye disease or abnormality
Any permanent eyeliner or eyelash implants of any kind
Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
Any use of prescription eyelash growth products
Any use of over the counter eyelash growth products during the 6 months prior to baseline
Any use of treatments that may affect hair growth during the 6 months prior to baseline
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: bimatoprost ophthalmic solution 0.03%
Eligibility criteria:
Inclusion Criteria:

Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

Any eye disease or abnormality
Any permanent eyeliner or eyelash implants of any kind
Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
Any use of prescription eyelash growth products
Any use of over the counter eyelash growth products during the 6 months prior to baseline
Any use of treatments that may affect hair growth during the 6 months prior to baseline
Intervention: Retapamulin
Trial phase: Phase 4
ATC code: D06AX13
SMILES: [H][C@@]12C(=O)CC[C@]13CC[C@@H](C)[C@@]2(C)[C@H](OC(=O)CS[C@@H]1C[C@H]2CC[C@@H](C1)N2C)C[C@@](C)(C=C)[C@@H](O)[C@@H]3C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
Eligibility criteria:
Inclusion Criteria:

Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.
Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.
An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.
Skin Infection Rating Scale score greater than or equal to 8.
Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.

Exclusion Criteria:

Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.
Allergic to any component of the test medication.
Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.
Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1.
Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.
Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study.
Recent alcohol or drug abuse is evident.
History of poor cooperation, non-compliance with medical treatment or unreliability.
Participation in an investigational drug study within 30 days of Baseline Visit.
Intervention: Riociguat
Trial phase: Phase 2
ATC code: C02KX05
SMILES: COC(=O)N(C)c1c(N)nc(-c2nn(Cc3ccccc3F)c3ncccc23)nc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants received a single oral dose of 1 mg riociguat.
Eligibility criteria:
Inclusion Criteria:

Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy

Exclusion Criteria:

Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 85
Group description: As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.

Exclusion Criteria:

patients with age less than 18 yr or over 60 yr,
emergency surgery,
patients undergoing neurosurgical procedures,
any procedure with adjunctive analgesia,
any patient on chronic opiate use,
females who are known to be pregnant,
patients who had ingested psychotropic or sedative medication within one month of investigation,
patients with personality disorders,
weight greater than 20% of ideal, and
any known contraindications to ketamine or propofol.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 85
Group description: As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.

Exclusion Criteria:

patients with age less than 18 yr or over 60 yr,
emergency surgery,
patients undergoing neurosurgical procedures,
any procedure with adjunctive analgesia,
any patient on chronic opiate use,
females who are known to be pregnant,
patients who had ingested psychotropic or sedative medication within one month of investigation,
patients with personality disorders,
weight greater than 20% of ideal, and
any known contraindications to ketamine or propofol.
Intervention: Quetiapine
Trial phase: Not Applicable
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent
Fluency in English
A diagnosis of PTSD
No pregnancy
Right-handedness

Exclusion Criteria:

Pregnancy or lactation
Any cognitive impairment that precludes informed consent
Known intolerance or lack of response to Seroquel
Previous enrollment or randomization of treatment in the present study
Participation in another drug trial within 4 weeks prior enrollment into this study
Patients with Diabetes Mellitus
History of allergic reaction or hypersensitivity to Seroquel
Contraindications to magnetic resonance imaging
Treatment with an effective medication for PTSD
Intervention: Welchol
Trial phase: Phase 2
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Six tablets per day (identical to colesevelam)

Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
Eligibility criteria:
Inclusion Criteria:

Age at entry at least 18 years.
Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
Evidence of hepatic steatosis or liver fat (>5%) by MRI.
Evidence of definite or suspected NASH
Written informed consent.

Exclusion criteria:

Evidence of another form of liver disease.
History of excess alcohol ingestion.
Contraindications to liver biopsy.
Decompensated liver disease.
History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
Recent initiation or change of anti-diabetic drugs.
Use of colesevelam or other agents in the same class.
Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
Positive test for anti-HIV.
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
Pregnancy or inability to practice adequate contraception in women of childbearing potential.
Evidence of hepatocellular carcinoma
Intervention: Welchol
Trial phase: Phase 2
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 3.75 grams per day

Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
Eligibility criteria:
Inclusion Criteria:

Age at entry at least 18 years.
Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
Evidence of hepatic steatosis or liver fat (>5%) by MRI.
Evidence of definite or suspected NASH
Written informed consent.

Exclusion criteria:

Evidence of another form of liver disease.
History of excess alcohol ingestion.
Contraindications to liver biopsy.
Decompensated liver disease.
History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
Recent initiation or change of anti-diabetic drugs.
Use of colesevelam or other agents in the same class.
Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
Positive test for anti-HIV.
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
Pregnancy or inability to practice adequate contraception in women of childbearing potential.
Evidence of hepatocellular carcinoma
Intervention: Diclofenac
Trial phase: Phase 3
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 147
Group description: NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
Eligibility criteria:
Inclusion criteria:

Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female
Moderate (30-60 mm) to severe (>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities
18 - 40 years of age
injury occurred within 24 hours of the first dose of study medication
Willing and able to give written informed consent
Available for the duration of the study

Exclusion Criteria:

Similar injury affecting the same joint within the past 6 months
bilateral ankle injury
bed rest, hospitalization, surgery use of a non-removable rigid cast
Clinically important abnormality for screening laboratory tests
Debilitating acute or chronic illness
Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
History of sensitivity to any component of the study drugs
Unwilling or unable to comply with all the requirements of the protocol
Participation in other studies within 4 weeks prior to study entry and or during the study participation
Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.

0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study
Eligibility criteria:
Inclusion Criteria:

Patients must meet the following criteria to participate in this study:

Age 18 years or older
Patients with diagnosis of MM schedule to receive high-dose melphalan, as a single agent ,for conditioning regimen
Signed Informed Consent Form

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

Patients who have taken palifermin (Kepivance) in the past 90 days
Patients who have taken any investigational drug in the past 60 days
Patient who have received radiation therapy in the past 60 days
Serum creatinine greater than 2 mg/dL
Patients with mucositis at the time of randomization
Patients with altered mental status precluding understanding of the informed consent process an/or completion of the necessary assessments