cyrilzakka/clinical-trials huggingface dataset:
Local Warming of Surgical Incisions

The purpose of this study is to determine if local warming of surgical wounds improves healing and helps prevent infection. The investigators want to see if warming surgical incisions improves oxygen levels and healing in skin close to the incision.

Surgical site infections (SSI) account for 37% of US hospital infections and increase morbidity and cost. High rates (10-22%) of SSI are associated with colorectal surgery and obesity. Bacterial resistance requires oxygen and higher tissue oxygen limits infection in general surgery patients. Control of core and local temperature may increase infection resistance by modulating perfusion, oxygenation, angiogenesis and immune cell responses. Perioperative hypothermia reduces tissue oxygen while normothermia lowers SSI rates. Warming injured tissues locally may offer additional benefit. Warming incisions immediately after surgery and intermittently for two days after gastric bypass or colectomy surgery reduced infection rates in a pilot sample. Systematic study of clinical outcomes and potential mechanisms in a larger study is lacking and is the focus of the current study.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older,
* scheduled for bariatric, colon or gynecological surgery,
* able to speak and read English.

Exclusion Criteria:

* glucocorticoids greater than 5 mg per day,
* albumin below 3.0,
* creatinine above 2.5 mg/dl,
* history of pulmonary edema.
Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures

Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures

This study uses a double pig-tail stent for cross fixation of a fully-covered stent in the duodenum to reduce the incidence of displacement and ensure the stent can effectively expand the narrowed area, thereby alleviating patient symptoms.

The aim of this study is to explore the safety and efficacy of a double pig-tail stent-assisted fixation of a fully-covered stent for the treatment of benign duodenal strictures, further clarifying its long-term efficacy and providing strong support for the placement of fully-covered stents in treating benign duodenal strictures.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily signed the informed consent form for this trial;
2. Patients diagnosed with benign duodenal stricture;
3. Symptoms of upper gastrointestinal obstruction, such as nausea, vomiting, abdominal pain, or changes in bowel habits, occurring before admission or during hospitalization;
4. Patients with refractory strictures who have failed multiple balloon dilations;
5. Age \< 75 years.

Exclusion Criteria:

1. Gastrointestinal perforation;
2. Distal small bowel obstruction or multiple segments of small bowel obstruction;
3. Coagulation disorders;
4. Strictures or obstructions caused by malignant tumors;
5. Severe comorbidities involving the heart, brain, lungs, kidneys, etc.
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection

The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients who are 18 years of age or older,
* Patients who are at least 6 months post first orthotopic liver transplantation (living or cadaveric donor) for treatment of end-stage liver disease due to HBV infection,
* Patients who have received HBIg since transplantation and are on a stable regimen (i.e., same dose and frequency) for at least the 3 months immediately preceding study entry (Day 1),
* Patients who have received treatment with an inhibitor of HBV polymerase for at least the 3 months immediately preceding study entry (Day 1),
* Patients with undetectable HBsAg and HBV DNA concentrations on two consecutive tests at least 1 week apart during the screening period,
* Female patients who are of childbearing potential, and males whose partners are women of childbearing potential, are required to use adequate contraception, and
* Patients who are able to provide written informed consent.
* Patients who successfully complete the initial 20-week treatment in the core trial are eligible for the 52-week extension phase.

Exclusion Criteria:

* Women who are pregnant or breastfeeding,
* Patients who have received another organ transplant that requires immunosuppression,
* Patients who are co-infected with hepatitis delta virus (HDV), hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV),
* Patients with clinical conditions or diseases, which, in the judgment of the investigator, would place the patient at undue risk, interfere with study participation, or confound the results of the study, and/or
* Patients who have participated in clinical studies in the 3 months prior to study entry.
The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms

The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. By repeating this on separate test days, the involvement of bodily processes is investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with normal hearing

Exclusion Criteria:

* Chronic pain conditions
* Other medical, psychiatric or neurological disorders
* Use of pain-relieving medication 24 hours prior to testing
Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)

This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

This study is reflecting the usual care either in accordance to the treating rheumatologist (arm: usual care) or in accordance to the international scientific recommendations (arm: T2T)

The tight control means that as soon as a treatment is initiated in a patient, the time permitting to evaluate its potential efficacy/safety has to be determined. In terms of safety, such time frame can be very short based on the occurrence of adverse events. In terms of efficacy it is usually recommended to evaluate an NSAIDs after 2 to 4 weeks of treatment intake and the TNF blockers after 12 to 16 weeks.

The Treat to Target means that there is an a priori decision of the target to reach while initiating a treatment and more importantly an a priori decision to intensify the treatment in case such target is not achieved.

There will be 2 arms in the study (tight control and treat to target arm and usual care arm).

160 patients (80 patients per arm) will be included during one year by 18 centers (10 in France, 4 in Belgium and 4 in Netherlands). Patients will be followed during 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Adults (between 18 and 65 years old)
* With a diagnosis of axial spondyloarthritis according to the axial ASAS criteria AND the opinion of the treating rheumatologist.
* Active disease defined as an ASDAS ≥ 2.1
* Predominant axial disease meaning that:

  * Patients with non-spinal rheumatological symptoms and/or extra-rheumatological manifestations requiring at baseline the initiation of a specific treatment will be excluded.
  * Patients with a past history and/or a current well controlled non-spinal rheumatological or extra-rheumatological features will be eligible for the study.
* Non-optimally treated with NSAIDs (i.e. who have not received at least 2 NSAIDS, daily during at least 2 weeks at full dose, during the last year). Annex II summarizes the list of commonly used NSAIDs and the definition of a "full" use.
* With available pelvic X-rays, B27 and MRI of the sacro-iliac joints (performed at any time since symptoms onset)
* With no contraindication to the use of a NSAID
* With no intake of apremilast during the previous 3 months
* Able to understand the objectives of the study and to fill the questionnaires
* Written informed consent.
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per square meter (kg/m\^2) at the screening visit
* Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical history)
* Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
* Woman of childbearing potential have a negative pregnancy test at screening
* Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

* History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
* History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Has a Hemoglobin A1c (HbA1c) of \>= 6.5% or fasting plasma glucose (FPG) \>= 126 milligrams per deciliter (mg/dL) (\>= 7.0 millimoles per liter \[mmol/L\]) at screening
* Screening calcitonin of \>= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
* History of glucagonoma
Anti-inflammatory Treatment for Inactive Takayasu Arteritis

Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
2. Inactive Takayasu arteritis according to National Institutes of Health criteria;
3. Age ≥ 14 and ≤ 40 years old at the time of informed consent;
4. Patients or guardian agree to participate in the study.

Exclusion Criteria:

1. Active Takayasu arteritis according to National Institutes of Health criteria;
2. Poor compliance, intolerance to or poor response to hormone therapy;
3. Allergy to contrast agent;
4. Renal insufficiency (serum creatinine \>133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase \>1.5 times upper limit of normal)
Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia

Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.

Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.

For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.

Randomisation

* No prophylaxis
* Preparation with a probiotic suspension before intubation.

Cultures

* oropharynx

  * before treatment
  * after intubation
  * before extubation
  * day 1 postoperatively
* tracheal secretions

  * after intubation
  * before extubation


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Planned interventions
* Anaesthesia \> 4 hours and requiring intubation

Exclusion Criteria:

* Ulcers in the mouth, oropharynx, oesophagus and stomach
* Current infections in the airways
* Known immuno deficiences
* Emergency cases
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

The purpose of this study is to examine the effects of marked alterations in ovarian steroid hormones on cognitive functions in women. Sex hormones and stress hormones of women awaiting or undergoing in-vitro fertilization (IVF) will be compared with levels of women adopting children and women on oral contraceptives.

Much of our understanding of the effects of ovarian steroid hormones on cognitive functioning comes from studies of changes in cognitive function associated with hormone replacement therapy (HRT) in post-menopausal women and changes in menstrual cycle phase in premenopausal women. If fluctuations in ovarian sex steroid hormone levels across the normal physiological range affect cognitive functions in women, then marked alterations in hormone levels should have a notable effect on cognitive function.

Hormonal in-vitro fertilization (IVF) treatments for female infertility result in dramatic fluctuations in estrogen levels. Women awaiting infertility treatment report negative emotions, depressed mood, declines in memory and concentration, and higher levels of reported stress compared to women who have never experienced infertility.

Four groups of twenty women each will be recruited for this observational study:

* Group 1 - IVF treatment with GnRH-a alone
* Group 2 - IVF treatment with GnRH-a plus sex steroid stimulating hormones
* Group 3 - ADPT control (women in the process of adopting children)
* Group 4 - OC (oral contraceptives) control

All groups will receive a cognitive/affect assessment twice, with a 3-week interval between assessments. Blood and salivary samples will be taken on the two test days to measure ovarian sex steroid hormone levels and stress hormone levels. Salivary samples will also be taken on a third day in between the two test days. Heart Period Variability (HPV), a measure of cardiac functioning, will be measured using electrocardiogram (ECG).

Eligibility Criteria:
Inclusion Criteria:

* Women 25 years and older, who are still ovulating
* Residing in Maryland or the Washington DC metropolitan area
* Healthy women in one of the following groups:
* 1) beginning or currently undergoing IVF infertility treatments with GnRH-a alone,
* 2) beginning or currently undergoing IVF infertility treatments with GnrH-a plus sex steroid stimulating hormones,
* 3) going through the adoption process, or
* 4) taking monophasic oral contraceptives for at least six months

Exclusion Criteria:

* English not the primary language
* Women who are peri- or post-menopausal
* Women who are currently taking anti-depressants or have a history of head injury or neurological/psychiatric condition
* Groups 1 \& 2 (IVF) - women who are undergoing Inter-uterine insemination as an infertility treatment
* Group 3 (ADPT) - women who underwent hormonal infertility treatments within the previous 6 months
* Group 4 (OC) - women on progesterone only (mini-pill) oral contraceptives
Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block

Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.

The study will be done in two phases. In the first phase, patients will be randomized to receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be compared with patients who did not receive it. In the second phase, we will assess whether patients can serve as their own controls by adding dexamethasone only to one side of the block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid consumption, level of blockade, and operator's prospective assessment of likely efficacy, based on the ultrasound visualization of the local anesthetic injection as compared with actual efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Male patients, between ages 18-85 years old, undergoing Robot-assisted laparoscopic prostatectomy by a single surgeon at a single hospital.
* Subjects are physically and mentally able to participate in the study.
* Subjects are able to give fully informed consent to participating in this study after demonstrating good understanding of the risks and benefits of the proposed components of the TAP block.

Exclusion Criteria:

* Demonstrated hypersensitivity or allergy to local anesthetics or dexamethasone.
* Any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block.
* Any subject, who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study.
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Cusatuzumab (also known as JNJ-74494550 and ARGX-110) is a humanized monoclonal antibody of camelid origin that binds with high affinity to human Cluster of Differentiation 70 (CD70). Azacitidine (an Hypomethylating agent \[HMA\]) is approved for the treatment of higher-risk MDS in the United States (US) and the European Union (EU). Both approvals are based on data showing decreased transfusion burden, delayed progression to acute myeloid leukemia (AML), improved quality of life, and extended survival. It is hypothesized that the addition of cusatuzumab to azacitidine will result in an improvement in overall response rate (ORR) compared with azacitidine alone in participants with higher-risk MDS or CMML.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016 criteria
* At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per Revised International Prognostic Scoring System \[IPSS R\]) OR higher-risk CMML (intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System \[CPSS-Mol\]). Participants with previous lower-risk MDS or CMML that has evolved to higher-risk MDS or CMML are eligible
* At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than (\<) 3 \* upper limit of normal (ULN); Total bilirubin less than or equal to (\<=) 1.5 \* ULN, unless bilirubin rise is due to Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater than (\>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) (by Modification of Diet in Renal Disease formula)

Exclusion Criteria:

* Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs), for higher-risk MDS or CMML. Prior supportive therapies including transfusion and growth factors are acceptable
* Received prior treatment with cusatuzumab
* Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl) rearrangement
* Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
* Any active systemic infection
OLA to Lowest DP in Cardiac Surgery

This study aims to compared the effects in driving pressure of an open-lung strategy with a positive end-expiratory pressure (PEEP) titrated to best driving pressure (DP) after a RM versus the recommended protective PEEP of 5 cmH2O without a recruitment manuever in non-obese patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Non-obese patients scheduled for cardiac surgery (CABG and valve replacement)

Exclusion Criteria:

* i) age \<18yr or \>80yr, ii) pregnancy or breast-feeding status, and iii) patients with previous known respiratory disease, iv) Body mass index \>35 kg/m2, v) emergency surgery and vi) hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device.