cyrilzakka/clinical-trials huggingface dataset:
Nasal Septal Flap for Donor Site Reconstruction

The purpose of this study is to demonstrate the utility of porcine small intestinal submucosa (SIS) as a graft material that may aid in the natural healing process of freshly exposed bone and cartilage in the nasal cavity.

Patients who undergo endoscopic endonasal skull base surgery, and may require nasoseptal flap placement as part of skull base reconstruction, will be informed, consented and enrolled for participation. If the intraoperative decision is ultimately made for harvest and placement of full-length nasoseptal flap by each individual surgeon, patients will then be consecutively, sequentially randomized to use of either:

* Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone (20 randomly assigned patients)
* 2x3 cm Biodesign™ SIS perforated mesentery graft surface placement plus overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone. (20 randomly assigned patients)

When used, Biodesign graft will be soaked in sterile saline out of the packaging, and placed as an intact single sheet over the exposed bone nasal septum bone/cartilage (without trimming). For uniformity and ease of future analysis, the bottom edge of the graft will be placed parallel to, and proximal to, the nasal floor cut edge remnant mucosal surface as possible. Except for a thin Doyle silastic sheet to cover the graft site, no additional reinforcement (suture/tissue glue) will be placed for those patients in the Biodesign graft arm.

Time Points and Study Parameters:

* All enrolled patients will have Doyle silastic sheeting removed only at 2 weeks post-op.
* All patients will receive 250cc normal saline topical nasal rinses starting at 14 days until 120 days post-op.
* No topical irrigation additives (budesonide/mupirocin) will be administered over 12 weeks.

All patients will be assessed at 2 weeks, 6 weeks and 12 weeks following randomization and entry into this study.

Eligibility Criteria:
Inclusion Criteria:

* Elective transnasal endoscopic skull base surgery where closure with a large nasoseptal flap (NSF) is anticipated (exposure of \>75% of the ipsilateral nasal septum bone/cartilage)
* Patients without nutritional compromise or otherwise debilitated
* Patients who are able to consent for themselves

Exclusion Criteria:

* Bilateral nasoseptal flap (NSF) placement in the same operative setting
* Patients without significant bone/cartilage exposure to incorporate an intact 2x3 cm graft
* Patients requiring 24 hour supplemental oxygen via nasal cannula
* Patients who cannot consent for themselves
Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)

This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* the patients who have participated in ANTG-ASC-210 clinical trial
* the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
* the patients who submit written informed consents and is able to obey requirements of trials

Exclusion Criteria:

* a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
* a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
* a patient who has an autoimmune disease
* a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* a patient who has a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
* a patient who is pregnant or breast feeding
* a patient who is not willing to use effective contraceptive methods during the study
* a patient who has inflammatory Bowel disease
* a patient who is sensitive to fibrin glue
* a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
* a patient who is not able to understand the objective of this study or to comply with the study requirements
* a patient who is considered to have a significant disease which can impact the study by investigator
* a patient who is considered not suitable for the study by investigator
* a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
* a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
* a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term
Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery

This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be lower than in women before they have the surgery. The investigators will ask several women to take a pack of birth control pills before having bypass surgery, and then another pack several months after surgery. The investigators will measure hormone levels in the blood. The investigators will also measure outcomes that may tell us how well the birth control pills are working, such as ultrasounds of the uterus and ovaries, and examination of the cervix.


Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo gastric bypass surgery at our institution
* willing to take 2 monthly cycles of the oral contraceptive: one cycle before and one after surgery
* use of Depo-provera within 6 months of enrollment
* Use of implantable or intrauterine contraception
* able to attend multiple study visits

Exclusion Criteria:

* Any contraindication to combined hormonal contraceptive use
* Surgical complications precluding further participation
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, \[123I\]ß-CIT, in research participants with Parkinson's disease.

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with \[123I\]ß CIT, an investigational radioactive material that localizes in the brain.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Normal screening laboratory studies
* At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment

Exclusion Criteria:

* Pregnancy
* Significant medical disease including abnormalities found on screening
Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.

The primary endpoint of the study is to to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..

The total number of patients to be included in this study is 60 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 19 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age: from 18 to 70 years old, female.
2. Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
3. The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
4. At least one measurable objective lesion according to RECIST 1.1 criteria.
5. ECOG performance status of 0-1.
6. LVEF≥55%.
7. Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
8. Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
9. Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

1. Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
2. Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
3. Severe systemic infection, or with other serious diseases.
4. Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
5. Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
6. Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
7. Have participated in other study studies within 30 days prior to the first dose of study drug.
8. Patients who, in the opinion of the Investigator, are not suitable for participation in the study.
Renal Autotransplantation; Case Series

Renal autotransplantation (RAT) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.RAT is a relatively new technique; the first ever RAT procedure in the US was performed in 1963. Advances in preservation and transplantation techniques have made RAT a modality that can be utilized in complex renal diseases. RAT is indicated for conditions such as renal vascular disease, nutcracker syndrome, pelvic venous congestion, pelvic trauma, refractory stone disease and, in some cases, loin pain hematuria syndrome and conventionally unresectable renal tumors.

Irrespective of the excellent outcomes shown by RAT, the conventional open approach requires a large midline xiphoid-to-pubis or flank incision for donor nephrectomy with a second pelvic incision for renal transplantation into the iliac fossa.The current gold standard approach to RAT is a laparoscopic nephrectomy followed by open auto-transplantation. However, this approach still requires a large pelvic incision. Robotic technology enables us to perform more complex minimally invasive surgery. Gordon et al. performed and reported the first completely intracorporeal robotic RAT to repair a ureteral injury in 2014.

This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.

Perioperative and short-term clinical data will be obtained from the EMR. All the data variables will be documented in the case report forms.

Because the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required.

Eligibility Criteria:
Inclusion Criteria:

* Subject was 18 years or older at the time of the procedure
* Subject who has undergone robotic RAT irrespective of the underlying etiology.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria
Sense2Stop:Mobile Sensor Data to Knowledge

The aim of this research is to build systems that can recognize when people are stressed and then provide them with relaxation prompts in the moment to reduce their likelihood of being stressed, smoking, or overeating in the near future. Using these systems should help smokers be more effective in their attempts to quit by reducing their tendency to lapse when they are stressed or experiencing other negative moods or behaviors.

The purpose of this study is (1) to evaluate the feasibility of a just-in-time intervention to decrease stress in recently quit smokers; and (2) to examine whether a just-in-time adaptive intervention that decreases stress also reduces the near-term odds of a smoking lapse.

The primary hypothesis of this study is that the administration of a prompt to perform a relaxation exercise as compared to no prompt will lead to a lower likelihood of being stressed in the subsequent two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The secondary hypothesis is that stress episodes will predict the timing of smoking lapses. The third hypothesis is that administration of a prompt to perform a relaxation exercise will reduce the odds of smoking for the next two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The fourth (exploratory) hypothesis is that stress will predict the timing of overeating episodes.

These data will also be used for developing automated risk prediction of smoking relapse, and for developing decision rules for the timing of Just-In-Time-Adaptive Interventions (JITAIs).

Eligibility Criteria:
Inclusion Criteria:

* Smokes 1+ cigarettes/day for past year
* Willing to try to quit smoking for at least 48 hours during a 15-day quit trial
* Will not use non-cigarette tobacco products or nicotine replacement therapy during the study period
* Not taking or intending to take pharmacological smoking cessation aids (e.g., nicotine replacement, bupropion, venlafaxene) during the study period

Exclusion Criteria:

* Unable to wear study devices due to skin irritation or sizing limitations
* Planning to move outside of Chicago area during study period
* Adults unable to provide informed consent
* Individuals who are not yet adults
* Pregnant women
* Prisoners
* Non-English Speakers
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
* CT scan with contrast medium available
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
* Horseshoe kidney
* Previous malignancy with ongoing or planned nephrotoxic chemotherapy
* Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
* Tumor thrombus in Vena renalis or Vena cava inferior
* Existing renal insufficiency GFR \< 15 ml/min/1.73m2
* Severe cognitive impairment
* Pregnancy or lactation or women with desire for children
* Patients under legal supervision or guardianship
* Unable to give informed consent or suspected lack of compliance
* Patients who refuse to data collection and storage for the main study
Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for inclusion into the study if they meet each of the following criteria:

* Men and women, aged 18 - 45 years.
* Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
* Non-childbearing potential or use of contraception (both sexes).
* Women must not be pregnant or lactating.
* Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .

Other Inclusion and Exclusion Criteria may apply.
Methylene Blue and Microcirculation in Septic Shock

This trial aims to identify the effects of methylene blue infusion on the the micro-circulation in patients with septic shock. The investigators will evaluate various indices of micro-circulation such as: microvascular ﬂow index, the flow heterogeneity index, the total vessel density, the perfused vessel density, and the proportion of perfused vessels.

The mortality rate of patients with septic shock remains very high. Arterial hypotension, related to arteriolar vasodilation and myocardial depression are the mainstays of septic shock pathology.

At the level of the micro-circulation, there is insufficient delivery of oxygen to organs and tissues which results in organ dysfunction and potential organ necrosis.One key factor leading to vascular dysfunction is the inappropriately increased production of nitric oxide within the blood vessel endothelium. Elevated levels of nitric oxide results in the blood vessel endothelium receiving direct vasodilator input, as well as the inability to respond to norepinephrine-mediated vasoconstriction. Nitric oxide activates the soluble isoform of the enzyme guanylatecyclase, which in turn increases production of cyclic guanosine monophosphate. Nitric oxide has other beneficial effects which are mediated via other pathways than guanylatecyclase; therefore, administration of a guanylate cyclase inhibitor such as methylene blue could be a safer therapeutic option than the inhibition of nitric oxide production.

These effects of methylene blue could be related to vasoconstriction and positive inotropic effects as well to an increase in blood volume, itself related to a decrease in vascular permeability. The use of methylene blue has been recently advocated as a potential adjunct in the treatment of shock states. However, the effect of MB at the level of the capillary bed, where vital exchange of oxygen and nutrients occurs, is unknown. Thus in this study, the investigators will investigate the effect of methylene blue in combination with NE at the microvascular level in septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock
* The patient is on norepinephrine infusion

Exclusion Criteria:

* Elevated serum creatinine (above 1.4 mg/dL)
* Pregnancy
Microbial Study of Sublingual Immunotherapy Tablets in Patients With Allergic Rhinitis

The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual tablet desensitization.

Exclusion Criteria:

* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis

The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.


Eligibility Criteria:
Inclusion Criteria:

* PAD with Rutherford class 1-4
* Resting ABI \<0.9 or abnormal exercise ABI \<0.9
* History of previous femoropopliteal nitinol stenting
* Angiographic significant restenosis (\>=50%)
* Target lesion length \>=4 cm; no more than 3 cm outside stent at either end
* Vessel diameter \>=5 mm and \<=7 mm
* At least one widely patent tibial or peroneal artery to the foot

Exclusion Criteria:

* Patient is pregnant or breast feeding
* Evidence of acute limb ischemia
* Life expectancy \<12 months
* CVA within 60 days of screening
* Myocardial infarction within 60 days of procedure
* Known allergy to contract media
* Known contraindication to aspirin, antiplatelet and anti-coagulation therapies
* Uncontrolled hypercoagulability
* Present or suspected systemic infection in target limb
* Serum creatinine \>= 2.5 mg/dl unless dialysis dependent
* Previous treatment to target vessel within 3 months of study procedure
* Drug eluting stents or covered stents in target lesion
* Ipsilateral and/or contralateral iliac stenosis \>= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis \<= 30% documented by angiography
* Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
* Identification of any lesion below the target stent in the treated leg \>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
* Tibial artery containing a \>50% Diameter Stenosis (DS) by visual estimate after popliteal
* Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.