cyrilzakka/clinical-trials huggingface dataset:
The Impact of Low Pressure Pneumo in RARP

The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).

Laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. The effects of increased intra-abdominal pressure on cardiopulmonary function has been well documented. Increased pressure on the large vessels may lead to decreased cardiac output and thereby decreased blood flow to various organ systems and cause irreversible damage. Some studies have advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al, for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were used. The purpose of this study is to evaluate the effect of using lower pressure pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic parameters including a reduction in the occurrence of post-operative ileus, reduced need for narcotics post operatively, and a decrease in cardiopulmonary complications.

The study is a prospective randomized blinded cohort study. Patients who meet eligibility criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 12mm Hg or 8mm Hg. This will be done by computer generated randomization protocol. Surgeon and patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over the AirSeal™ system so that the surgeon(s) are not able to visualize the pneumoperitoneum used during the procedure. The remainder of the procedure will be carried out based on current standard of care.

All patients will be admitted post operatively and the same standardized order-set in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.

Eligibility Criteria:
Inclusion Criteria:

* Male 40 years of age or older
* Diagnosis of prostate cancer
* Have been evaluated to be fit for proposed surgery
* Patients able to consent

Exclusion Criteria:

* Patients unable to consent (cognitively impaired)
* Non-English speaking
Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.

The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (\> 0.5 cm) and vascularity of skin flap after mastectomy.

The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.

In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.

The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction

Eligibility Criteria:
Inclusion Criteria:

* patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
* adequate mastectomy flap in vascularity and thickness

Exclusion Criteria:

* none
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms (DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety will be evaluated on the basis of adverse events, clinical laboratory tests, physical examination, vital signs assessment and cardiovascular safety assessment. An interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study. Treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles. Continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment, is eligible to receive further therapy, and consents to treatment. If disease progression has not occurred at treatment termination, then disease assessment will continue every 8 weeks until there is evidence of disease progression or death, or until the clinical data cutoff date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
* Prior treatment with only 1 platinum based chemotherapy regimen
* Eastern Cooperative Oncology Group status of not more than 2
* Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion Criteria:

* Treatment with more than 1 prior chemotherapy regimen
* Progression within 6 months after starting initial chemotherapy
* Prior exposure to anthracyclines
* Unwilling or unable to have central venous catheter
* Known clinically relevant central nervous system metastasis
MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

In this study, diffusion tensor imaging（DTI）technique was used to evaluate the brain microstructures and connective white matter microstructures in patients with refractory FD, resting fMRI was used to evaluate the functional connectivity between hemispheres, and neuroimaging changes after antidepressant intervention were observed to explore the activation patterns of resting brain homeostasis-receptive network areas in patients with refractory FD. We aimed to explore microstructure of white matter and gray matter and functional connectivity between hemispheres to explain the therapeutic mechanism of antidepressants.

In this study, functional magnetic resonance imaging (fMRI) was used to investigate the abnormal activation patterns of brain regions in patients with refractory FD in resting state, and to observe the changes of brain functions after antidepressant treatment, in order to find scientific evidence for exploring the etiology, neuropathological mechanism and the mechanism of antidepressant treatment of refractory FD.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old, meeting the criteria for inclusion of refractory FD
* HP infection negative
* Right handedness

Exclusion Criteria:

* Antidepressant drug allergists
* History of gastroduodenal surgery;
* Researchers judged suicidal ideation.
* Women in pregnancy or lactation.
* Patients with uncorrected narrow angle glaucoma.
* There was a history of epileptic seizures.
* suffering from any serious or unstable medical disease or disease.
* Addiction to illicit drugs or alcohol and unwillingness to discontinue use during the study period.
* Patients can't express their complaints correctly and can't cooperate with the researcher.
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis

The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.

The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.

Design: Prospective, randomized, placebo-controlled, double-blinded study.

Population: 60 patients with chronic active ulcerative colitis and steroid dependency

Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.

Main criteria: complete steroid reduction

Eligibility Criteria:
Inclusion Criteria:

* Signed Letter of Content
* diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence)
* chronic active and steroid dependent course over at least 4 months (CAI \> 4, EAI \> 4)

Exclusion Criteria:

* infectious colitis
* toxic megacolon
* ulcerative proctitis or less than 20cm inflamed
Periodontal Health Status in Patients with Systemic Sclerosis

The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* established diagnoses of systemic sclerosis and periodontitis (study group),
* age ≥ 18
* presence of minimum 12 teeth

Exclusion Criteria:

* concurrent inflammatory mediated rheumatic diseases
* pregnancy or lactation
* active cigarette smokers
* a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.
Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil.

Exclusion Criteria:

* Uncontrolled major medical illnesses
Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification

The prospective study is a interventional study to evaluate and compare the effectiveness of periosteal pedicle as grafting technique and egg shell derived nano hydroxyapatite as regenerative graft material for regeneration of intrabony defects.

30 Patients visiting the outpatient Department of Periodontology Krishnadevaraya College of Dental Sciences and Hospital, Bangalore will be enrolled for 6 month folllow up study based on the inclusion and exclusion criteria. Patients age ranged from 25 to 55 years. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects are included in the study.

The patients are allocated to three goups through computer generated randomisation as:

Group A (n=10) - Egg shell derived nano hydroxyapatite (EnHA) graft and periosteal pedicle as barrier membrane.

Group B (n=10) - Only EnHA as graft. Group C (n=10) - An open flap debridement procedure only.

Eligibility Criteria:
Inclusion Criteria:

1. Patients within the age group of 25 to 55 years.
2. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects as detected on CBCT.
3. Gingival biotype \>1.5mm
4. Systemically healthy subjects.
5. Patients who are compliant.
6. Patients who had not received any periodontal treatment in the last six months.

Exclusion Criteria:

1. Pregnant and Lactating females.
2. Aggressive periodontitis.
3. Presence of pulpal or periapical involvement.
4. Patients with known systemic diseases and conditions precluding any elective surgery.
5. Patients who were smokers.
6. Teeth with poor prognosis.
TSI and Its Relationship With Graves' Disease Relapse

The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:

1. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
2. To determine an optimal cut-off of TSI level for predicting GD relapse.
3. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.

Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
* TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.

Exclusion Criteria:

* Hyperthyroidism due to other causes
* Patients who were intolerant to ATD or had serious side effects with ATD.
* TSIs were measured in pregnancy.
* Patients treated with surgery or radioactive iodine.
Risedronate in Postmenopausal Women With Low Bone Density

The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months

The secondary objectives are :

* To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
* To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.
* To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
* To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory women,postmenopausal \>= 5 years
* have lumbar spine baseline BMD within the following criterion :

  * Hologic: \<= 0.827 g/cm2 or
  * Lunar: \<= 0.942 g/cm2 or
  * Norland: \<= 0.768 g/cm2
* be in general good health as determined by medical history, physical examination and laboratory tests

Exclusion Criteria:

* serum 25-OH vitamin D level \<= 12 ng/ml
* history of osteomalacia
* history of active hyperparathyroidism or hyperthyroidism
* hypocalcemia or hypercalcemia from any cause
* depot injection \>10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
* use of Vitamin D supplementation within 3 months prior to starting the investigational product
* use of any of the following medications within a specified number of months prior to starting the investigational product :

  * any bisphosphonate.
  * use of any fluoride with the exception of fluoride use for oral hygiene
  * strontium
  * other bone active agents
  * subcutaneous estrogen implant
  * oral or parenteral glucocorticoids
  * anabolic steroids
  * estrogen or estrogen-related drugs, except for low dose vaginal creams
  * progestogen
  * calcitonin, calcitriol, or calcifediol
* any allergic or abnormal reaction to bisphosphonates
* creatinine clearance \< 30 ml/min
Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.

Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.

Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.

Statistical analysis:

The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference \< 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Jehova's witness
Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity

For children who depend on devices to communicate, the rate of communication is a primary determinant of success. For children with motor impairments, the rate of communication may be limited by inability to contact buttons or cells rapidly or accurately. It is therefore essential to know how to adjust the device interface in order to maximize each child's rate of communication. The optimal rate of communication is determined by the Channel Capacity, which is the maximum value of the Information Rate for all possible keyboard button or cell layouts for the communication device. We construct a mathematical model for the information rate based on the relationship between movement time and the number of buttons per screen, the size of the buttons, and the length of a sequence of buttons that must be pressed to communicate each word in the vocabulary. We measure the parameters of the model using a custom-programmed touch-screen interface.


Eligibility Criteria:
Inclusion Criteria:- Use of Dynavox ability to follow two-step commands impairment in arm function Exclusion Criteria:- increased risks of study
Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients

Quality Improvement Project to evaluate how prehabilitation can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

The aim was to evaluate how prehabilitation (PH) can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Patients underwent PH (exercise, nutrition and psychological support) before resection of colorectal carcinoma in a DGH over fourteen months. Patients were matched by operation, age, sex and ASA to non-prehabilitation (NPH) patients using a prospectively maintained database. Length of stay (LoS) and complication rate and 90-day readmission rates were compared using Wilcoxon and McNemar's methods.

Prehabilitation significantly improved peak VO2 and AT. This corresponds to a reduction in predicted 30-day mortality. Despite a higher Charlson index LoS was unchanged suggesting prehabilitation may permit safe resection in comorbid patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 who had prehabilitation for colorectal cancer

Exclusion Criteria:

* Children
* Patients who had prehabilitation but not for colorectal cancer