anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. TRI-LUMA Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. TRI-LUMA Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.

In clinical trials involving TRI-LUMA Cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 13 women became pregnant during treatment with TRI-LUMA Cream. Most of the pregnancy outcomes are unknown. Three women gave birth to apparently healthy babies. One pregnancy was terminated prematurely, and another ended in miscarriage.

In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to TRI-LUMA Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogenesis due to topical exposure to TRI-LUMA Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy.

Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

• In a dermal application study using TRI-LUMA Cream in pregnant rabbits, there was an increase in the number of in uterodeaths and a decrease in fetal weights in litters from dams treated topically with the drug product. 

• In a dermal application study in pregnant rats treated with TRI-LUMA Cream during organogenesis there was evidence of teratogenicity of the type expected with tretinoin. These morphological alterations included cleft palate, protruding tongue, open eyes, umbilical hernia, and retinal folding or dysplasia.

• In a dermal application study on the gestational and postnatal effects of a 10-fold dilution of TRI-LUMA Cream in rats, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation were observed. An increase in overall activity was seen in some treated litters at postnatal day 22 and in all treated litters at five weeks, a pattern consistent with effects previously noted in animals exposed in uterowith retinoic acids. No adequate study of the late gestational and postnatal effects of the full-strength TRI-LUMA Cream has been performed. 

• It is difficult to interpret these animal studies on teratogenicity with TRI-LUMA Cream, because the availability of the dermal applications in these studies could not be assured, and comparison with clinical dosing is not possible.
Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.
Eosinophilic esophagitis (EE) is a chronic, increasingly recognized disease of the esophagus, clinico-pathologically characterized by a proton-pump-inhibitor resistant, dense esophageal eosinophilia in combination with esophagus-related symptoms. Patients suffer mainly from dysphagia, a feared long-term complication is the evolution of esophageal stenoses leading to food-bolus impaction that have to be removed endoscopically. Anti-inflammatory therapy with systemic or topical corticosteroids have shown to be efficacious in children as well as in adults. However, relapses occur in general soon after the cessation of this medication. In addition, several studies have demonstrated that in adults with active EE dilation is an alternative safe and efficacious therapeutic option. Surprisingly, the symptom-free period seems to be much longer after this procedure than after medical treatment. Today, the selection of these two procedures depends more on local practices than on evidence based data, because robust data are lacking. Furthermore, there are concerns regarding the risk of the dilation-procedure (possible esophageal perforations and major bleeding). Furthermore, it has not yet been assessed if dilation changes the underlying eosinophilic inflammation. If not, investigations should be performed to evaluate if long-term anti-eosinophilic therapy is able to change the natural course of the disease and reduce the stricturing complications.
Preclinical studies have shown the kidney to be the major target organ for mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after a 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral > 900 mg/kg dose, and after I.V. doses of > 214 mg/kg. Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/kg/day female rats. Minimal tubular epithelial damage was seen in the 40 mg/kg/day males and was reversible. In a six-month oral study in dogs, the no-observable dose level of mesalamine was 40 mg/kg/day and doses of 80 mg/kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed at doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman’s capsule were seen at 100 mg/kg/day and above. In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see Pharmacokinetics). Overt renal toxicity has not been observed (see ADVERSE REACTIONS and PRECAUTIONS), but the potential must be considered.
Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \< cT1 undergo bladder sparing.
Currently, treatment pathways for Ogilvie's Syndrome suggest observation and attempted correction of the potential precipitating factors for 24 to 72 hours following radiologic assessment if the cecum is less than 12cm and abdominal imaging does not demonstrate signs of impending perforation. Should symptoms fail to resolve beyond 72 hours, and the cecum remain under 12cm without worsening clinical status, pharmacologic intervention with neostigmine is indicated. Symptoms resolve in 60% to 90% of patients following administration of single dose of neostigmine, however continued monitoring is required as up to 40% of these patients can experience recurrent colonic dilation. Additionally, neostigmine can be associated with serious adverse events such as bradycardia and bronchospasm. Altogether, there may be potential for further optimization of the pharmacologic management of Ogilvie's Syndrome.

Given the predominant theory that Ogilvie's Syndrome is caused by sympathetic overdrive, the splanchnic sympathetic blockade provided by epidural anesthesia could be of theoretical benefit. In 1988, a small, prospective cohort study evaluated the use of epidural anesthesia in eight patients with Ogilvie's Syndrome. Symptoms were controlled and cecal dilation resolved without recurrence in 62.5% of these patients, and the authors concluded that with further study, the use of epidural anesthesia could be a reasonable alternative to neostigmine. Yet, no subsequent studies were performed.

This proposed single-arm, single-center prospective cohort pilot study will examine the feasibility, safety, and efficacy of epidural anesthesia in patients with Ogilvie's Syndrome refractory to conservative management. Adult patients with a documented diagnosis of Ogilvie's Syndrome admitted as an inpatient to St. Joseph's Healthcare Hamilton (SJHH) who failed conservative management will be included. Following assessment of eligibility and the informed consent process, patients will be evaluated by the acute pain service anesthesiologist. A low-dose bupivacaine (0.25%) infusion will commence following insertion of an epidural catheter at the T11-12 interspace, with a loading dose of 5-10mL followed by a 3mL per hour infusion. Monitoring for resolution of disease will take place iteratively by the general surgery team, and failed symptom resolution will mandate further treatment in the form of colonoscopic decompression or surgical intervention. Patients will be followed throughout their index hospital and stay and up to 30 days following discharge from hospital. Feasibility will be assessed through recruitment rate and rate of successful epidural placement. The rate of epidural anesthesia-related morbidity within 30 days of treatment will serve as the primary safety measure. The primary efficacy measure is clinical and radiologic resolution without recurrence.
Pathogenic changes in gut microbial composition precede the onset of HIV-1 infection in men who have sex with men (MSM). This process is associated with increased levels of systemic inflammatory biomarkers and risk for AIDS development. Using mediation analysis framework, in this report we link the effects of unprotected receptive intercourse among MSM prior to primary HIV-1 infection to higher levels of proinflammatory cytokines sCD14 and sCD163 in plasma and a significant decrease in the abundance of A. muciniphila, B. caccae, B. fragilis, B. uniformis, Bacteroides spp., Butyricimonas spp., and Odoribacter spp., and a potential increase in the abundance of Dehalobacterium spp. and Methanobrevibacter spp. in stools of MSM with the highest number of sexual partners. These differences in microbiota, together with a reduction in the pairwise correlations among commensal and short-chain fatty acid-producing bacteria with a number of sexual partners, support an increase in gut dysbiosis with the number of sexual partners. These results demonstrate the interconnectedness of sexual behavior, immune response, and microbiota composition, notably among MSM participating in high-risk sexual behaviors.
After low anterior resection(LAR), a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube until the anastomotic leakage was cured.
OBJECTIVE: To investigate the accuracy and effectiveness of acetabular cup placement in total hip arthroplasty (THA) after lumbar fusion applying of modified acetabular anteversion and inclination angles test system.
METHODS: A clinical data of 45 patients undergoing THA for osteoarthritis between January 2018 and June 2023 was retrospectively analyzed. All patients had previously received lumbar fusion. The modified acetabular anteversion and inclination angle test system was used in 26 cases (observation group) and not used in 19 cases (control group) during THA. There was no significant difference in baseline data such as gender, age, body mass index, operative side, number of lumbar fusion segments, and preoperative Harris score between the two groups ( P>0.05). The position of acetabular prosthesis, hip function (Harris score), and incidence of complications were compared between the two groups.
RESULTS: In the observation group, all acetabular cups were in the safe zone (anteversion angle, 25°-30°) during operation, and 1 acetabular cup (3.85%) was not in the safe zone after operation. In the control group, 9 acetabular cups (47.37%) were not in the safe zone. The postoperative difference between the two groups was significant ( P<0.05). There was no significant difference between intra- and post-operative acetabular inclination angles in the observation group ( P>0.05), and the postoperative acetabular inclination angle was significantly smaller in the observation group than in the control group ( P<0.05). All incisions healed by first intention and no infection occurred. All patients were followed up 6 months. There was no significant difference in Harris score between the two groups at different time point ( P>0.05), and there were significant differences between different time points in the two groups ( P<0.05). No joint dislocation occurred in the observation group during follow-up, while dislocation occurred in 2 cases and femoral impingement syndrome occurred in 1 case of the control group. There was no significant difference in the incidence of complications between the two groups ( P>0.05).
CONCLUSION: For THA patients with lumbar fusion, the ideal placement angle of the acetabular cup can be obtained by using the modified acetabular anteversion and inclination angles test system during operation.
This is a single-center, open-label, pharmacokinetic drug interaction study between folic acid (1 mg) and study drug (250 mcg NGM/35 mcg EE) in 2 groups of at least 20 healthy women each. In Group 1, a single oral dose of 250 mcg NGM/35 mcg EE study drug was administered to the healthy volunteers at the study site on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 at the study site and 1 tablet of study drug was administered on Days 2 to 17. Blood samples were collected at specified times for 72 hours postdose on Days 1 and 17 for the healthy volunteers in Group 1 for determination of blood levels of norelgestromin (NGMN), and norgestrel (NG) \[the active breakdown product of NGM\], and EE. For the healthy volunteers in Group 2, blood samples were collected for 24 hours after the folic acid dose on Days 1 and 17 for determination of plasma levels of total folates. Safety was evaluated based on the following: the incidence, type and severity of adverse events; clinical laboratory tests; vital sign and electrocardiogram (ECGs) measurements; and physical examinations. Oral temperature, pulse, respiratory rate, and sitting blood pressure (BP) were taken before dosing on Days 1 and 17. For Group 1, measurements were taken before and at least 15 minutes after the 24-hour (Days 2 and 18), 48-hour (Days 3 and 19), and 72-hour (Day 4) pharmacokinetic blood draw; and at study completion (Day 20) or early withdrawal. For Group 2, measurements were taken before and at least 15 minutes after the 24-hour pharmacokinetic blood draw on Days 2 and 18; and at study completion (Day 18) or early withdrawal. Physical and gynecologic examinations and 12-lead ECGs were performed at screening and at study completion or early withdrawal. Blood samples for blood chemistry, hematology, and urine samples for urinalysis were collected at the screening visit and at the follow-up visit or early withdrawal.

Oral contraceptives tablet (250 mcg NGM/35 mcg EE); Folic acid tablet (1 mg). In Group 1, a single oral dose of (250 mcg NGM/35 mcg EE) study drug was administered on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 and 1 tablet of study drug was administered on Days 2 to 17. Study drugs were taken with 240 mL (8 oz) of water at approximately 8:00 a.m.
PURPOSE: A composition containing Rhus verniciflua bark extract or galate derivative isolated from the same are provided to ensure significant anti-scuticociliatida activity. CONSTITUTION: A composition for preventing or treating scuticociliatida infection of fishes contains Rhus verniciflua bark extract as an active ingredient. The Rhus verniciflua bark extract is isolated using non-polar solvent extract. The non-polar solvent is n-hexane, CHCl3, EtOAc, n-BuOH, or H_2O. A composition for preventing or treating scuticociliatida infection contains Rhus verniciflua bark extract-derived methyl galate of chemical formula 1 or a galate derivative of chemical formula 2 as an active ingredient. The galate derivative is gallic acid, ethyl galate, propyl galate, butyl galate, or isoamyl galate.
Thoracic outlet syndrome (TOS) consists of a group of disorders resulting from compression of the neurovascular bundle exiting through the thoracic outlet. TOS can be classified as follows based on the etiology of the pathophysiology: neurogenic TOS, venous TOS, arterial TOS, and mixed TOS. The constellation of symptoms a patient may experience varies, depending on the structures involved. Due to the wide range of etiologies and presenting symptoms, treatments for TOS also differ. Furthermore, most studies focus on the perioperative and short-term outcomes after surgical decompression for TOS. This systematic review aimed to provide a pooled analysis of studies to better understand the intermediate and long-term outcomes of surgical decompression for TOS. We conducted a systematic literature search in the Ovid MEDLINE, Embase, and Google Scholar databases for studies that analyzed long-term outcomes after surgical decompression for TOS. The inclusion period was from January 2015 to May 2023. The primary outcome was postoperative QuickDASH Outcome Measure scores. A total of 16 studies were included in the final analysis. The differences between postoperative and preoperative QuickDASH Outcome Measure scores were calculated, when possible, and there was a mean overall difference of 33.5 points (95% CI, 25.2-41.8; P = .001) after surgical decompression. There was a higher proportion of excellent outcomes reported for patients undergoing intervention for arterial and mixed TOS etiologies, whereas those with venous and neurogenic etiologies had the lowest proportion of excellent outcomes reported. Patients with neurogenic TOS had the highest proportion of poor outcomes reported. In conclusion, surgical decompression for TOS has favorable long-term outcomes, especially in patients with arterial and mixed etiologies.
Pregnancy Category C: There are no adequate and well controlled studies of Asacol use in pregnant women. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. Animal reproduction studies of mesalamine found no evidence of fetal harm. However, dibutyl phthalate (DBP) is an inactive ingredient in Asacol’s enteric coating, and in animal studies at doses >190 times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. Asacol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes. 

Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm to the fetus. These mesalamine doses were about 1.6 times (rat) and 3.2 times (rabbit) the recommended human dose, based on body surface area. 

Dibutyl phthalate (DBP) is an inactive ingredient in Asacol’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol tablets is about 21 mg. Published reports in rats show that male rat offspring exposed in utero to DBP (≥100 mg/kg/day, approximately 39 times the human dose based on body surface area), display reproductive system aberrations compatible with disruption of androgenic dependent development. The clinical significance of this finding in rats is unknown. At higher dosages (≥500 mg/kg/day, approximately 194 times the human dose based on body surface area), additional effects, including cryptorchidism, hypospadias, atrophy or agenesis of sex accessory organs, testicular injury, reduced daily sperm production, permanent retention of nipples, and decreased anogenital distance are noted. Female offspring are unaffected. High doses of DBP, administered to pregnant rats was associated with increased incidences of developmental abnormalities, such as cleft palate (≥630 mg/kg/day, about 244 times the human dose, based on body surface area) and skeletal abnormalities (≥750 mg/kg/day, about 290 times the human dose based on body surface area) in the offspring.