anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Travoprost
Trial phase: Phase 2
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.

Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Eligibility criteria:
Inclusion Criteria:

Able and willing to attend scheduled follow-up exams for the duration of the study
Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
Best spectacle corrected visual acuity of 20/80 or better in each eye.
Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

Exclusion Criteria:

Glaucoma status as follows:

Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders

Corneal status as follows:

Any active inflammation or edema
Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
Implantation of Travoprost Intraocular Implant
Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)

Fellow eye status as follows:

Fellow eye actively enrolled in this trial or any other clinical trial

Subject status as follows:

Pregnant or planning to become pregnant during the course of the study
Intervention: IVERMECTIN
Trial phase: Phase 3
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.

Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Eligibility criteria:
Inclusion Criteria:

Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively.

Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;

Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in oxygen receiving patient
Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)
Mechanical ventilation requirement
Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure assessment) score >2

Exclusion Criteria:

Patients with the following characteristics were excluded from the study.

Pediatric patients; <18 years of old
Patients with chronic liver or kidney disease
Pregnant women
Patients with known ivermectin allergy
Intervention: Cabergoline
Trial phase: Phase 2
ATC code: G02CB03 | N04BC06
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N(CCCN(C)C)C(=O)NCC)CN2CC=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.

Cabergoline 1 MG: Dopamine agonist
Eligibility criteria:
Inclusion Criteria:

Pregnant people, ages 18 years or older
Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
Consented for an induced, elective abortion or undergoing induction for demise
English or Spanish speaking
Able to consent for a research study, literate in English or Spanish
Willing to comply with study procedures and follow-up
Access to smart phone throughout study

Exclusion Criteria:

Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
Currently breastfeeding
Currently receiving dopamine agonist therapy for other indication (prolactinoma, Cushings syndrome, acromegaly, restless leg syndrome)

Contraindication to cabergoline (as per package insert)

Uncontrolled hypertension - defined as baseline BP > 150/100, or chronic hypertension requiring more than one baseline medication, or pregnancy-induced hypertension spectrum disorders (gestational hypertension, preeclampsia, eclampsia)
History of cardiac valvular disorders or valvular repair
History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
Intervention: Natrii lactatis solutio composita
Trial phase: Phase 3
SMILES: CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Administration of Intravenous Fluid using Lactated Ringer's solution per standard of care resuscitation protocol for patients with moderate sized burn injuries (20-40% TBSA).

Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation
Eligibility criteria:
Inclusion Criteria:

All genders
Adults aged ≥18 years who present with moderate-sized burn injuries [20 - 40% total body surface areas (TBSA)] to the Nepal Cleft and Burn Center within 24 hours of injury.

Exclusion Criteria:

Patients with electrical burns, chemical burns, inhalation injury.
Patients in overt shock (defined as serum lactate >2.5, or hypotension and altered mental status).
Pregnant patients, psychiatrically unstable patients will be excluded.
Patients with oropharyngeal defects and/or previously known diagnoses leading to high risk of aspiration, and/or precluding safe nasal-enteric access will be excluded.
Patients will history of chronic nausea and/or vomiting, including those with a diagnosis of gastroparesis due to diabetes mellitus will be excluded.
Patients with a Baux score of over 100 (age + TBSA), patients with declared palliative intent on admission, and patients for whom clinicians have high level of clinical concern based on clinical judgement will also be excluded.
Intervention: Sildenafil
Trial phase: Early Phase 1
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Upon arriving at the laboratory, participants will ingest a liquid mixture containing Sildenafil (100 mg), an inhibitor of phosphodiesterase 5.

Sildenafil 100 mg: Sildenafil inhibits phosphodiesterase 5, an enzyme that degrades cyclic guanosine monophosphate in the vascular smooth muscle cells inactivating the nitric oxide-mediated signal; thus, Sildenafil will prolong the availability of cyclic guanosine monophosphate, enhancing the nitric oxide-mediated intracellular cascade.
Eligibility criteria:
Inclusion Criteria:

Self-identification of their race and the race of their biological parents as being only Black (i.e., African American) or only White (i.e., Caucasian American)
Born and raised in the United States

Exclusion Criteria:

Mixed races
Any chronic or ongoing disease
Prescribed pharmacological treatment
Smoking or tobacco use
Obesity (body mass index > 30 kg / m2)
Intervention: Sildenafil
Trial phase: Early Phase 1
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Upon arriving at the laboratory, participants will ingest a liquid mixture containing a placebo.

Sildenafil 100 mg: Sildenafil inhibits phosphodiesterase 5, an enzyme that degrades cyclic guanosine monophosphate in the vascular smooth muscle cells inactivating the nitric oxide-mediated signal; thus, Sildenafil will prolong the availability of cyclic guanosine monophosphate, enhancing the nitric oxide-mediated intracellular cascade.
Eligibility criteria:
Inclusion Criteria:

Self-identification of their race and the race of their biological parents as being only Black (i.e., African American) or only White (i.e., Caucasian American)
Born and raised in the United States

Exclusion Criteria:

Mixed races
Any chronic or ongoing disease
Prescribed pharmacological treatment
Smoking or tobacco use
Obesity (body mass index > 30 kg / m2)
Intervention: Ridinilazole
Trial phase: Phase 3
SMILES: c1cc(-c2nc3ccc(-c4ccc5nc(-c6ccncc6)[nH]c5c4)cc3[nH]2)ccn1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.

Ridinilazole: Ridinilazole 200mg dosed BID for 10 days.
Eligibility criteria:
Inclusion Criteria:

Is aged 12 to <18 years.
Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.

Exclusion Criteria:

Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.
Intervention: Octyl 4-O-Beta-D-Allopyranosyl-1-Thio-Beta-D-Altropyranoside
Trial phase: Phase 3
SMILES: CCCCCCCCSC1OC(CO)C(OC2OC(CO)C(O)C(O)C2O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention

OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Eligibility criteria:
Inclusion Criteria:

any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion Criteria:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Intervention: Baxdrostat
Trial phase: Phase 2
SMILES: CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)
Eligibility criteria:
Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;
Intervention: Baxdrostat
Trial phase: Phase 2
SMILES: CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)
Eligibility criteria:
Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;
Intervention: Baxdrostat
Trial phase: Phase 2
SMILES: CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) or withdraw study participation depending on BP control
Eligibility criteria:
Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;
Intervention: Articaine
Trial phase: Phase 3
ATC code: N01BB08 | N01BB58
SMILES: CCCNC(C)C(=O)Nc1c(C)csc1C(=O)OC
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 61
Group description: Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.

AG-920: AG-920 Sterile Topical Ophthalmic Solution
Eligibility criteria:
Inclusion Criteria:

Pre-pubescent with no childbearing potential
Capable of undergoing an eye exam
Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
Have a healthy, normal cornea.

Exclusion Criteria:

Have participated in an investigational study (drug or device) within the past 30 days.
Have a known contraindication to local anesthetics.
Children with known autism spectrum disorders or known to have heightened sensitivity.
Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
Have low visual acuity
Manifest nystagmus
Have had ocular surgery or general surgery within the past 45 days.
Have had an intravitreal injection in either eye within 14 days of randomization.
Have ocular surface disease.
Intervention: IVERMECTIN
Trial phase: Phase 3
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 817
Group description: Ivermectin - 7-mg tablets

Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.

Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
Eligibility criteria:
Inclusion Criteria:

Completed Informed Consent
Age ≥ 30 years old
Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

Exclusion Criteria:

Prior diagnosis of COVID-19 infection (> 10 days from screening)
Current or recent (within 10 days of screening) hospitalization
Current use of study drug or study drug/device combination*
Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo*
Known contraindication(s) to study drug including prohibited concomitant medications*

[If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.]

Arm-specific exclusion criteria:

End-stage renal disease on renal replacement therapy
Liver failure or decompensated cirrhosis
Use of warfarin, CYP3A4, P-gp inhibitor drugs, or CYP3A4 substrates
Nursing mothers
Pregnancy