cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

The patient's long-term inadequate food intake leads to malnutrition, decreased quality of life, and impacts the prognosis of the disease. Currently, both domestically and internationally, treatment options for cricopharyngeal muscle dysfunction include balloon dilation technique, surgical incision, and botulinum toxin injection. Passive dilation with a balloon can easily cause mucosal edema and damage. Cricopharyngeal myotomy surgery often presents complications such as local infection, excessive bleeding, and local nerve damage. Botulinum toxin can alleviate muscle spasms and has been widely used in the treatment of hypertonic disorders \[3\]. Common injection localization methods include ultrasound, electromyography, and endoscopy. Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. Combining it with balloon fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Eligibility Criteria:
Inclusion Criteria:

* Videofluoroscopic swallowing study (VFSS) confirming incomplete/opening dysfunction of the cricopharyngeal muscle;
* No significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased FOIS);
* Presence of swallowing initiation, with VFSS showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the C3 vertebral body;
* Stable vital signs, alert consciousness, and cooperation with treatment;

Exclusion Criteria:

* Patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases;
* Abnormalities in the pharynx and larynx structures;
* Patients with malignant tumors;
* Patients with infections or wounds at the injection site;
* Patients allergic to botulinum toxin; Patients with bleeding tendencies or coagulation disorders.
Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

1. To evaluate whether early enteral nutrition may be decreased the postoperative complications
2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
3. To determine the optimal method for postoperative nutritional support

Eligibility Criteria:
Inclusion Criteria:

* Periampullar carcinoma
* Pancreaticoduonectomy
* KARNOFSKY PERFORMANCE SCALE \> 70
* No history of Major operation

Exclusion Criteria:

* Creatinine level\>3mg/L
* Ascitis/portal hypertension
* New York Heart Association class\>3
* COPD
* Preoperative Radiotheraly/chemotherapy
* Unresectable primary cancer
* Palliative surgery
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* IBS \& subjective sensitivity to wheat

Exclusion Criteria:

* celiac disease, pregnancy, lactation, IBD, major GI operations
Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.

Study to compare of two contrast agents in imaging brain lesions.


Eligibility Criteria:
Inclusion Criteria:

* Known neoplastic CNS lesions
Two Different Regimens of Misoprostol in Retained Placenta

This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Eligibility Criteria:
Inclusion Criteria:

* women with a singleton pregnancy, delivered vaginally
* 28 weeks of gestation and more,
* had a prolonged third stage of labor (more than 30 minutes) despite active management,
* Haemodynamically stable and accept to participate in the trial

Exclusion Criteria:

* multiple pregnancies,
* previous caesarean delivery,
* haemodynamically instability, severe anaemia (haemoglobin concentration \<8 g/dL),
* chorioamnionitis
* Refused to participate in the trial
Study on Gamma Sensory Flicker for Insomnia

This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.

This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.

A total of 37 participants underwent polysomnography (PSG) prior to the commencement of the study.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of insomnia according to DSM-5 Cumulative score of ≥7 on the seven-factor components of the Pittsburgh Sleep Quality Index. Sleep disturbances manifest at least three times per week.

Exclusion Criteria:

Secondary insomnia related to other mental disorders Substance-induced sleep disorders Environmental sleep disorders Sleep apnea syndrome. Stroke patients Insomnia caused by physical diseases, Severe ophthalmic diseases Brain tumors Suspected or confirmed history of alcohol or drug abuse Psychoactive drugs Pregnancy Previous participation in clinical trials within the past three months Epilepsy or family history of epilepsy.
UV Exposure Assessed With Wearable Sensor and Sun Protection

The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with relevant, easy-to-access, specifically actionable information. This research proposal will develop a UV protection system consisting of an automated real-time counseling framework and a personal dosimeter that overcomes barriers to consumer adoption. These new, wearable sensors take the form of small (\< 1 cm), thin (\<0.1 mm), lightweight (\<0.1 g), battery-free "stickers" that are fundamentally differentiated from other wearable electronics in their modes of use, cost structures and accuracy.

The proposed work is to refine and validate a UV protection system based on a dosimeter "sticker." The key innovations of the system are automated personalized intervention messaging triggered by the exposure levels measured by a novel charge accumulation device applied to ultraminiaturized circuit forms. The research will validate the system's accuracy and acceptability to users, refine the device, and prove its robustness and efficacy in real world use cases. Focus groups and structured interviews will develop sun protection strategies to be communicated by text messages to participants. Successful completion of the research will yield a system to prevent excessive UV exposure and sunburn, thus reducing the incidence of skin cancer by equipping large numbers of general-population consumers and at-risk people to practice digitally-informed healthy sun behavior.

Eligibility Criteria:
Cohort Study 1:

Inclusion Criteria:

1. history of Stage 0 to IIB melanoma treated within the last five years, age 18-70 years old
2. have a smartphone
3. familiarity with use of mobile apps
4. have skin type 1-3
5. willing to wear the sensor and able to transmit data which requires Wi-Fi in the home
6. Come to the Chicago campus of the medical school

Exclusion Criteria:

-

Cohort Study 2: Young adults with sun sensitive skin

Inclusion Criteria:

1. history of sun sensitive skin, skin type 1-3
2. have a smartphone and willing to use the UV guard application on the smartphone
3. reliable wireless internet connection to complete daily surveys
4. willing to wear the sensor for 28 days and transmit data and complete daily surveys
5. willing to receive SMS text messages on their personal phone and potentially sync sensor to personal phone using Bluetooth
6. If weather permits, person will spend at least one hour outdoors each day, with at least 30 minutes of that hour being consecutive between the hours of 8 AM and 5 PM

Exclusion Criteria:

1. unable to speak English
2. lacking a secure Internet connection or very little experience with smartphones and mobile applications .
3. unable to walk inside and outside independently
4. unable to be outdoors for at least one hour each day (weather permitting)
5. unable to be outdoors for 30 consecutive minutes a day between 8 AM and 5 PM.
A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* degenerative cervical disease
* radiculopathy or myelopathy refractory to conservative treatment
* be scheduled to undergo one segment anterior cervical discectomy and fusion
* age is more than 19 years old
* all requirements of preoperative image studies are satisfied

Exclusion Criteria:

* previous neck surgery or radiation treatments at neck area
* fusion at adjacent segments
* two segment fusion is expected
* C2-3 or C7-T1
* high risk for additional cervical surgery within one year
* ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
* inadequate radiological images
* patient is not expected to be observed at long term follow-up (foreigner, international student)
Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada

The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed elagolix as part of standard treatment
* Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study
* Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea
* Has provided written informed consent allowing the use of their data for the study

Exclusion Criteria:

* Did not consent
* Cannot fill out questionnaires
* Prescribed elagolix for a period of 1 or 2 months only
* Post-menopausal (naturally or surgically)
* Symptomatic uterine fibroid(s)
* Had medical treatment for uterine fibroids (any length of treatment)
Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19

The present work proposes to find if a bio-active composite in the hemolymph or plasma of the freshwater bivalve Anodonta cygnea is able to offer immunity and specificity for meliorating the major symptoms in human SARS and COVID-19 lineage infection. The Methodology concerns in silico procedures using organic fluids from 54 bivalves (in very specific conditions) to evaluate their therapeutic effects in 6 voluntary SARS and COVID-19 infected persons with an integrative diagnosis by a computational Mora®Nova apparatus to access the basal and experimental human physiological parameters.

A deep and consistent study will be developed with an increase in the human sampling for better understanding the intervention efficacy of this intelligence medicine integrator, the Mora® Nova method. These in silico experiments when associated with the bioresonance frequencies from stimulated hemolymph compounds of the freshwater bivalve A. cygnea, may lead us to expect high plasticity and immunological potential.

Obviously, additional in vitro studies in future, with adequate culture cell lineages in different conditions and with bioresonance treatment by Mora® Nova method, should also be accomplished with hemolymph/plasma interference to confirm the pertinence, and the real efficacy on SARS / COVID-19 infection as well as to clarify the respective biological mechanisms.

In addition, to analyze and evaluate any specific bioactive compound from the induced hemolymph condition needs molecular experiments which can give deep structural information concerning any efficient molecule against the SARS / COVID-19 virus lineage and respective mutants. Effectively, according to current scientific opinion, the virus mutation phenomenon leads to great and problematic difficulty for maintaining the collective and human global immunization. In this case, the present Mora methodology offers a very functional, dynamic, and efficient process when combined with a biological model, as the bivalve A. cygnea, with high plasticity and eventual molecular reconstructive adaptation. This Mora procedure can extend to other immune-depressive diseases namely cancer, rheumatoid arthritis, and neurodegenerative diseases combining with respective stimulated bivalve fluids. It suggests opening a promising future perspective when applied to large human sampling as well as with in vitro cellular assays.

In addition, to explore this research with in vitro cell cultures and to do the characterization and the effects from bio-compounds on similar diseases is our close objective.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal physiological state or any kind of comorbidity

Exclusion Criteria:

* Subjects in highly critical health state
Predictive Values for the Outcome of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain

Researchers are trying to assess a predictive value or correlation between patient and procedural characteristics and outcome measures results after genicular nerve radiofrequency ablation.

Genicular nerve radiofrequency stimulation procedure is an effective treatment for patients with chronic pain due to knee osteoarthritis; however, little is known about factors that predict procedure success. This study evaluated correlation between patient characteristics and procedural characteristics and pain improvement after ultrasound guided genicular nerve radiofrequency stimulation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient's 18 years or older
* Patients who recently underwent ultrasound guided genicular nerve radiofrequency (RF) procedure

Exclusion Criteria:

* lack of documentation of predictive factors to assess outcome
* Patients in whom adequate follow-up data was not available
* Patients who were prescribed a new analgesic drug or received concurrent treatments for different pain sources during the follow-up period, that could affect interpretation of genicular RF treatment results.
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
* Stable diet and exercise program for at least 8 weeks before the study
* On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
* BMI of 20.0 to 45.0 kg/m2
* A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

Exclusion Criteria:

* Type 1 diabetes mellitus
* Proliferative diabetic retinopathy
* Receiving insulin within 12 weeks prior to the study
* History of clinically significant renal disease(s)
* Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
* Urinary tract infection or genital infection
* Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
* History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
* Severe infection, serious trauma, or perioperative subject
* Known or suspected hypersensitivity to ASP1941
* History of treatment with ASP1941
* Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
* Serum creatinine value exceeding the upper limit of normal range
* Urinary microalbumin/urinary creatinine ratio \>300 mg/g
Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease

Mesenchymal stem cells (MSC) have been shown to have immunosuppressive properties. Following a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a condition called 'graft versus host disease' (GVHD). In this condition the transplanted cells recognize the recipient as foreign and bring about an immune-mediated destruction of tissues. The treatment for this condition is to use drugs that will cause immunosuppression. A small subset of these patients develop a severe form of GVHD (Grade III or IV) which, in spite of the best currently available treatment, is associated with eventual death in more than 90% of cases. The investigators propose to use infusions of expanded MSC from the donor to treat this condition. A few reports on this approach have already been published in peer reviewed journals and preliminary results appear to be promising. The investigators are also aware that larger trials have been initiated to study this. After getting written informed consent, the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD.

A single center non randomized, non blinded Phase I/II clinical trial is proposed to study the role of mesenchymal stem cells (MSC) in the management of steroid refractory graft versus host disease (GVHD) following an allogeneic stem cell transplant.

Patients who develop grade II to IV GVHD following an allogeneic stem cell transplant will be enrolled. MSC will be expanded from the donors of all patients who develop GVHD. Expanded MSC will be infused at a dose of 1-2 million cells/kg in patients who have steroid refractory GVHD.

Response to therapy will be studied using established criteria for grading GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from patient and donor
* Any patient who has undergone HLA-matched related allogeneic stem cell transplantation with steroid refractory Grades II-IV acute GVHD
* Prednisolone 2 mg/kg/day (or equivalent doses of methylprednisolone, etc.) for at least one week

Exclusion Criteria:

* Invasive fungal disease
* Active cytomegalovirus (CMV)/Epstein-Barr virus (EBV)/varicella disease
* Relapsed malignancy
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Background:

Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator that increases local blood flow by dilating arteries and veins without altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.

Objective:

To evaluate if the post-operative application of NTG ointment improve rates of MFN in patients undergoing SSM or NSM with immediate breast reconstruction compared to patients receiving placebo.

Hypothesis:

In patients undergoing SSM and immediate breast reconstruction there will be a decrease in the rate of MFN in those who receive NTG ointment compared to those who receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo SSM or NSM with immediate alloplastic or autologous breast reconstruction
* Unilateral and bilateral cases (in bilateral cases only the mastectomy performed by the general surgeon will be included. This will avoid the potential effect of absorption of nitroglycerin from one breast to the other)
* Patients older than 21 and less than 65

Exclusion Criteria:

* Patient declining inclusion in the study
* Patient with medical history that precludes the administration of nitroglycerin, i.e. a medical history significant for

  * Acute circulatory failure accompanied by clear hypotension
  * Myocardial insufficiency related to obstruction
  * Use of sildenafil, vardenafil \& tadalafil
  * Use of beta-blockers, calcium channel blockers, diuretics or phenothiazides
  * Salicylates (ASA)
  * Alteplase
  * Recent history of MI or cardiac insufficiency
  * Anemia, severe
  * Cerebral hemorrhage or recent head trauma
  * Glaucoma
  * Hepatic function impairment, severe
  * Hyperthyroidism
  * Hypertrophic cardiomyopathy
  * Hypotension
  * Sensitivity to nitrites
* Patient with a history of mantle radiation
* Patient with an allergy to polysporin or any of its ingredients
Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia

Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for an interventional rigid bronchoscopy under general anesthesia

Exclusion Criteria:

* pregnant woman or woman of childbearing age,
* morbid obesity,
* drug allergy,contra-indication to succinylcholine, rocuronium, sugammadex, propofol, remifentanil,
* history of central neurological or brain damage,
* psychotropic treatment,
* pacemaker,
* renal failure,
* disease of the neuromuscular junction.