cyrilzakka/clinical-trials huggingface dataset:
Focal Cryoballoon Ablation for Malignant Dysphagia

Rationale:

Dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment. Current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely/ temporary symptom improvement. Recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. Moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. However, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. Secondly, cryo-immunologic data in patients with EC is lacking.

Objective:

1. To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed.
2. To evaluate the effect of cryoballoon ablation on host's anti-tumor response. Study design: Pilot study, Multi-center Prospective Uncontrolled Intervention

Study Study population: Adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma Intervention (if applicable): Focal cryoballoon ablation of visible tumor during an upper endoscopy. Cryoballoon ablation will be performed for two cycles of 12 seconds. In total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient.

Main study parameters/endpoints:

* - Feasibility of cryoballoon ablation defined as technical success of the procedure

  * Safety based on incidence of procedure-related serious adverse events
  * Efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor
* Host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples


Eligibility Criteria:
Inclusion Criteria:

* Age \&amp;gt;18 years at time of consent
* Histopathologically-confirmed esophageal / gastroesophageal cancer
* Patients in the palliative setting (with or without (future) systemic chemotherapy)
* Dysphagia defined as a score of ≥2 (able to swallow only semi-solids)
* Signed written informed consent

Exclusion Criteria:

* Alternative etiology for dysphagia
* Inability to pass the ultraslim endoscope
* Severe medical comorbidities precluding endoscopy
* Uncorrected coagulopathy
* Prior distal esophagectomy
* Previous esophageal varices
* Expected survival \&amp;lt;6 weeks
* Prior radiotherapy for esophageal cancer
* T4b esophageal cancer
* Incapacitated subjects
* Pregnant or breastfeeding
Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density

The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral missing premolars
* Remaining bone height more ≥ 10mm.
* Remaining bone width ≥ 6mm

Exclusion Criteria:

* patients that smoke more than 10 cigarettes/day
* Patients with uncontrolled systemic disease.
* Presence of bone pathology within the future osteotomy site
Evolution of Fatigue in Patients With Inflammatory Bowel Disease

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.

Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.

Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.

In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.

As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.

Patients with inflammatory bowel disease and fatigue (FACIT-F score \< 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score \<40 points) previously documented in our two previous studies.
* Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
* Ability to understand the questionnaires.

Exclusion Criteria:

* Associated tumor disease.
* Pregnancy or breastfeeding.
* Anemia (hemoglobin \<12g/dl in women and 14g/dl in men)
* Any concomitant illness that may justify the presence of fatigue.
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG

Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated.

The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG, including progressing normal tension glaucoma (NTG) based on recent or recurrent disc haemorrhage
* No anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to SD0 and absent throughout the study
* Aged more than 18 years, of either sex
* Not more than 4 diopters spherical equivalent on both eyes
* Not more than 2 diopters cylinder equivalent on both eyes
* Have given written informed consent, prior to pre-study screening

Exclusion Criteria:

* Patients with history of ocular surgery within the last 3 months
* Corneal or conjunctival abnormality hindering contact lens adaptation
* Severe dry eye
* Secondary forms of OAG
* Patients with systemic hypertension
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Wear of full frame metallic glasses during Triggerfish® monitoring
* Patients not able to understand the character and individual consequences of the investigation
* Simultaneous participation in other clinical research
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT

Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.

Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Internal Hernia After Laparoscopic Gastric Bypass

To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent

Exclusion Criteria:

* Conversion to open surgery prior to the randomization
* Patients not giving a written consent
Matrix Metalloproteinases After Surgery and/or Radiofrequency Ablation in Patients With Liver Metastases From Colorectal Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial is studying matrix metalloproteinases after surgery or radiofrequency ablation in patients with liver metastases from colorectal cancer.

OBJECTIVES:

Primary

* Describe the kinetics of postoperative changes of serum matrix metalloproteinases (MMP) (MMP-1, MMP-2, MMP-7, MMP-9) and their inhibitors (TIMP) (TIMP-1, TIMP-2) as a function of surgical technique.

Secondary

* Determine the predictive value of postoperative risk of recurrence.
* Correlate the risk of recurrence with surgical technique.
* Determine whether elevated serum levels of MMP are a better marker than the carcinoembryonic antigen of hepatic or extrahepatic recurrence.
* Determine whether the postoperative serum of HGF/SF is correlated to changes in plasma levels of MMPs.

OUTLINE: Blood samples are collected periodically before and after treatment to analyze for metalloproteinases and their inhibitors.

After completion of study treatment, patients are followed at day 45 and then every 3 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Patients with histologically confirmed adenocarcinoma of the colon or rectum and liver metastases

    * Must have undergone prior complete resection of the tumor more than 3 months ago
    * Liver metastases must be resectable or accessible for radiofrequency ablation
  * Patients undergoing cryosurgery of the digestive tract for a reason other than cancer or infection (control)

PATIENT CHARACTERISTICS:

* No other neoplastic disease that is measurable or being treated other than colorectal cancer
* No heart failure or severe respiratory disease
* No uncontrolled infection or other severe disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No participation in another study involving new drugs
Improving Bowel Function and Quality of Life After Spinal Cord Injury

Bowel dysfunction is consistently rated as one of the most common complications affecting daily life for individuals with spinal cord injury. The overall objective of this study is to investigate whether the use of specific spinal cord epidural stimulation will affect bowel function. This study will also examine how alterations in bowel function influence quality of life outcomes. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired bowel function.

Participants in this study must be enrolled in the TS - EPI study (IRB# 16.0179) which provides the spinal cord epidural implant and training interventions. You will receive two sets of interventions, each one lasting 80 sessions for a total of 160 sessions. Assessments for bowel function and quality of life will be performed as part of this study and are conducted at baseline/pre-training, post-Intervention 1, post-Intervention 2, and at the 6-month and 12-month follow-ups. Your participation in this study will last up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of enrollment
* At least 2 years post injury
* Non-progressive spinal cord injury
* Stable medical condition
* Unable to voluntarily move all joints of the legs
* Unable to stand independently
* Cardiovascular dysfunction including presence of persistent resting low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in 24 hour period
* Bowel dysfunction as a result of spinal cord injury

Exclusion Criteria:

* Ventilator dependent
* Untreated painful musculoskeletal dysfunction, unhealed fracture or pressure sore
* Untreated psychiatric disorder or ongoing drug abuse
* Colostomy bag
* Any implanted pump (i.e., baclofen pump, pain pump, etc)
* Cardiovascular or bowel dysfunction unrelated to SCI
* Ongoing nicotine use
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique

The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

Five (5) adult subjects without a history of penicillin allergy and fifteen (15) adult subjects with a history of penicillin allergy and previous positive penicillin skin test to the minor determinant (penicilloate) and/or major determinant (penicilloyl) will be enrolled into the study. Each subject will be skin tested with our current penicillin skin test which includes penicilloate conducted in the Division of Allergic Diseases will be compared the skin test of our penicilloate prepared by our newer method along with the different diastereoisomers of penicilloic acid on the same day and time. The adult subjects without a history of penicillin allergy will serve as our control.

Eligibility Criteria:
Inclusion Criteria:

1. History of penicillin allergy
2. Previous or current positive skin test to penicilloate
3. Greater than or equal to 18 years of age

Exclusion Criteria:

1. Uncontrolled asthma by symptoms
2. Patients who have received penicillin and had no adverse drug reaction
3. Previous adverse reaction to penicillin skin test
4. Dermatological conditions that may interfere with skin testing i.e. atopic dermatitis and dermatographism
5. Medication that may interfere with skin testing i.e. antidepressants, antihistamines, and sedatives.
Effects of Ospemifene on Pelvic Vascularity and Blood Flow

Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (Osphena, Shionogi, Florham, NJ) or placebo tablet. Placebo tablets will be identical in appearance and packaging will be identical for the two pills. The participants will be instructed to take one tablet in the morning with food for twelve weeks. Basic demographic information will be obtained on all participants. All women will undergo a pelvic examination, and questionnaires regarding pelvic floor dysfunction and sexual function before and three months after treatment. 3-D ultrasound with Doppler blood flow analysis will be performed before the patient is started on the treatment. 3 months after treatment, the 3-D ultrasound with Doppler blood flow analysis will be repeated. Four areas will be measured:

1. The urethra in exactly the same section at the same level with the same setups.
2. 3 and 9 O'clock position
3. 6 o'clock position
4. Clitoral blood flow Doppler blood flow will be visualized using the Doppler color mode of the ultrasound machine and will be applied for the assessment of the vascularity pattern. Additionally, we will record a film with the use of Color Doppler in a video file. The transducer will be immobilized at one selected section and record a ten seconds of film. This film will be further analyzed in special software called Pixel flux after the examination. Dr. Pawel Wieczorek and Dr. Magdalena Wozniak will read these deidentified video files in a randomized fashion based on their previous research experience with similar video interpretations of pelvic color Doppler imaging \[8-11\].


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Available for reliable follow up
* Able to complete study assessment
* Mammogram within the last year
* Menopausal (at least 12 months since last spontaneous menstrual bleeding)

Exclusion Criteria:

* Age \<18 years
* Dementia or inability to follow instructions
* Prior pelvic floor radiation
* History of uterine, ovarian, fallopian tube, breast, or colon cancer
* Current use or use within the last 6 months of estrogen (vaginal, oral, transdermal, compounded)
* Current use of alternative medicines including black cohosh, evening primrose, dong quai, or chasteberry
* Known prothrombotic mutations such as Factor V Leiden, prothrombin mutation, protein C or Protein S deficiency
* History of or current thrombophelbitis or venous thromboembolic disorders
* Currently using fluconazole or rifampin
Suprainguinal Fascia Iliaca Block in Knee Arthroplasty

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

The primary purpose of this study is; To evaluate the effects of suprainguinal fascia iliaca block on recovery and recovery in the postoperative period in patients who will undergo total knee arthroplasty surgery, using the quality of recovery-15T score.

Secondary purpose; Postoperative rest and movement numeric rating scale, patient likert scale, first rescue analgesia duration, number of patients needing rescue analgesia, total amount of rescue analgesic consumed, complications such as nausea and vomiting, and antiemetic requirements in patients who will undergo total knee arthroplasty surgery with suprainguinal fascia iliaca block is to evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo unilateral total knee arthroplasty
* Patients who will undergo spinal anesthesia
* Patients aged 18-65 years, ASA I-III
* Patients who will stay in the hospital for at least 24 hours

Exclusion Criteria:

* Patients who do not want to give consent
* Patients who do not want spinal anesthesia
* Patients for whom regional anesthesia is contraindicated
* Patients with confusion
* Patients with coagulopathy
* Patients using anticoagulants
* Patients with infection in the area to be treated
* Those who are allergic to local anesthesia
* Emergency cases