anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Daily injections

Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.

Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
Eligibility criteria:
Inclusion Criteria:

Patients with type 1 diabetes mellitus: Fasting c-peptide < 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis.
Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
HbA1c of less than 8.5%.
Well versed with carbohydrate counting
Age 18-75 years

Exclusion Criteria:

Type 1 diabetes for less than 12 months;
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
Hepatic disease (transaminase > 3 times normal) or cirrhosis;
Renal impairment (serum creatinine > 1.5);
HIV or Hepatitis C positive status;
Participation in any other concurrent clinical trial;
Any other life-threatening, non-cardiac disease;
Use of an investigational agent or therapeutic regimen within 30 days of study.
history of pancreatitis
pregnancy
inability to give informed consent
history of gastroparesis
history of medullary thyroid carcinoma or MEN 2 syndrome.
Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Daily injection

Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.

Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
Eligibility criteria:
Inclusion Criteria:

Patients with type 1 diabetes mellitus: Fasting c-peptide < 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis.
Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily
HbA1c of less than 8.5%.
Well versed with carbohydrate counting
Age 18-75 years

Exclusion Criteria:

Type 1 diabetes for less than 12 months;
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
Hepatic disease (transaminase > 3 times normal) or cirrhosis;
Renal impairment (serum creatinine > 1.5);
HIV or Hepatitis C positive status;
Participation in any other concurrent clinical trial;
Any other life-threatening, non-cardiac disease;
Use of an investigational agent or therapeutic regimen within 30 days of study.
history of pancreatitis
pregnancy
inability to give informed consent
history of gastroparesis
history of medullary thyroid carcinoma or MEN 2 syndrome.
Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks

Plecanatide
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
Hard or lumpy stools ≥ 25 % of defecations
Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period
Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Plecanatide 1.0mg one tablet by mouth daily for 12 weeks

Plecanatide
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
Hard or lumpy stools ≥ 25 % of defecations
Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period
Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks

Plecanatide
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
Hard or lumpy stools ≥ 25 % of defecations
Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period
Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks

Plecanatide
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
Hard or lumpy stools ≥ 25 % of defecations
Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period
Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Rasagiline
Trial phase: Phase 4
ATC code: N04BD02
SMILES: C#CCN[C@@H]1CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Rasagiline 1 mg oral tablets once daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
Hoehn and Yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3 (mild-to-moderate bilateral disease; some postural instability; physically independent)
Mild cognitive impairment in Parkinson's disease based on the Movement Disorder Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment (MoCA) rating scale (range, 20-25, inclusive)
Medically stable outpatient, based on the investigator's judgment
The patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (Screening/Baseline Visit)
Other inclusion criteria apply; please contact the site for more information

Exclusion Criteria:

Clinically relevant history of vascular disease (eg, stroke)
History of melanoma
History of deep brain stimulation (DBS)
Impaired hepatic function, based on the investigator's judgment
Psychosis or is receiving antipsychotic treatment
Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment
Other exclusion criteria apply; please contact the site for more information
Intervention: Cholecalciferol
Trial phase: Not Applicable
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: Child | Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.

Vitamin D
Eligibility criteria:
Inclusion Criteria:

children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.

Exclusion Criteria:

age less than 4 years
pregnant females
previous or known history of Vitamin D deficiency or insufficiency
current use of Vitamin D supplementation or multi-vitamin containing >800 IU daily
or concurrent development and/or history of other significant systemic illness or non-endocrine autoimmune disorder.
Intervention: Growth hormone
Trial phase: Not Applicable
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.

Growth hormone
Eligibility criteria:
Inclusion Criteria:

Ages 18-65 and generally healthy
BMI ≥ 25 kg/m2
Bone mineral density (BMD) T score ≤ -1.0 and > -2.5 (as measured by DXA)

Exclusion Criteria:

For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
History of diabetes mellitus, cancer or other serious chronic disease
Use of osteoporosis medications
Anemia
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Febuxostat for 7-9 days

Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of TLS (according to the TLS risk stratification, Cairo M et al, British Journal of Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
Life expectancy > 1 month

Exclusion Criteria:

Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations
Patients with sUA levels ≥ 10 mg/dL at randomization
Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization
Patients with severe renal and/or hepatic insufficiency
Patients with diagnosis of LTLS or CTLS at randomization
Intervention: Allopurinol
Trial phase: Phase 3
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Allopurinol for 7-9 days

Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies at intermediate or high risk of TLS (according to the TLS risk stratification, Cairo M et al, British Journal of Haematology, 2010)candidate to Allopurinol treatment or have no access to Rasburicase
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
Life expectancy > 1 month

Exclusion Criteria:

Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations
Patients with sUA levels ≥ 10 mg/dL at randomization
Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization
Patients with severe renal and/or hepatic insufficiency
Patients with diagnosis of LTLS or CTLS at randomization
Intervention: Meropenem
Trial phase: Phase 3
ATC code: J01DH02 | J01DH52
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](C(=O)N(C)C)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 217
Group description: Meropenem powder for solution for infusion 1000mg
Eligibility criteria:
Inclusion Criteria:

Patient must be 18 to 90 years of age, inclusive,
Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years, with chronic genotype 1 HCV infection
HCV RNA equal to or greater than 10,000 IU/mL at screening
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol