cyrilzakka/clinical-trials huggingface dataset:
Efficacy of PICO Single-use System in Chronic Ulcers

A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.

Due to the current scientific and clinical evidence shows that NPT offers guarantees as complementary care, improving healing and reducing amputations in patients with chronic ulcers, treatment with PICO single-use NPT, should be considered as the first option.

This clinical trial include adults from the Hospital General Universitario of Toledo with 2 arms (intervention and control) and the intervention will last 12 weeks.

The intervention proposed in the study will consist of evaluating the decrease in size, the healing rate, the adverse effects and the quality of life related to the health of the patients compared with traditional treatments.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes over 18 years.
* Patients with chronic ulcers: venous leg ulcer, diabetic foot ulcer or pressure ulcers.
* Patients capable of complying with the protocol instructions and signing the informed consent (IC) or with limited capacity to act, in which case their relatives would be informed, who would be the ones who would grant the signed informed consent.
* Acceptable state of health.

Exclusion Criteria:

* Malignant ulcers.
* Ulcers with abundant exudate.
* Non-modifiable anatomical location to create hermetic seal of the dressing.
* Suspected or known allergy to components of TPN systems.
* Pregnancy.
* Serious cardiovascular diseases.
* Diagnosis of vasculitis or claudication.
* Current administration of systemic chemotherapy or corticosteroids.
* Having received prior treatment with TPN or hyperbaric oxygen in the 7 days prior to screening.
* Leukopenia, thrombocytopenia, anemia, increased bilirubin or three times the level of liver enzymes.
* Deep venous thrombosis.
* Refusal or inability to tolerate compression therapy, exposure of muscles, tendons or bone.
* Diagnosis of active Charcot foot syndrome.
* Malnutrition or eating disorders.
Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 50 years
* American society of anesthesiology (ASA) physical status I - II
* Body mass index (BMI) less than 30.0 kg/m2
* Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure
* Under general anesthesia.

Exclusion Criteria:

1. Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
2. Pregnancy or lactation.
3. Patients with a history of allergy to aminophylline.
4. Coffee consumption (more than 2 cups/day)
5. Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
6. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.
Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80; diagnosed as UC

Exclusion Criteria:

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent
A Study of GW842166 in Adults With Osteoarthritis Pain

The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.


Eligibility Criteria:
Inclusion Criteria:

* male or female outpatient, \>= 40 years of age
* meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
* meets ARA functional status requirements
* meets WOMAC pain subscale score requirements
* has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen

Exclusion Criteria:

* any pre-specified clinical/biological/ECG abnormality
* any pre-specified drug sensitivity
* history of peptic ulceration or GI bleeding
* use of protocol-specified medications
* secondary cause of knee OA
* lower extremity surgery within 6 months of screening
* use of analgesics other than allowed per protocol
* use of corticosteroids or hyaluronan outside of allowed window prior to screening
Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study

* Prospective, randomized, controlled, multi-center study
* A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions
* Patients will be followed clinically for 1 year after the procedure.
* Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Clinical criteria:

  1. Age 19 years of older
  2. Symptomatic peripheral artery disease:

     1. Moderate or severe claudication (Rutherford category 2 or 3)
     2. Critical limb ischemia (Rutherford category 4 or 5)
  3. Patients with signed informed consent
* Anatomical criteria:

  1. Target lesion length ≥150 mm by angiographic estimation
  2. Stenosis of more than 50% in femoropopliteal artery
  3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria:

* A. Clinical criteria

  1. Acute critical limb ischemia
  2. Severe critical limb ischemia (Rutherford category 6)
  3. Major bleeding history within prior 2 months
  4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
  5. Age \> 85 years
  6. Severe hepatic dysfunction (\> 3 times normal reference values)
  7. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
  8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  9. LVEF(left ventricular ejection fraction) \<40% or clinically overt congestive heart failure
  10. Pregnant women or women with potential childbearing
  11. Life expectancy \<1 year due to comorbidity
* Angiographic criteria

  1. Previous bypass surgery or stenting of the superficial femoral artery
  2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion
  3. Popliteal artery stenosis \>50% at P2 or P3 segment
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.

Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room.

Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.

Eligibility Criteria:
Inclusion Criteria:

1. INR level between 1.50 and 2.50 inclusive
2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology

Exclusion Criteria:

1. undergoing a surgical procedure in the operating room;
2. active bleeding;
3. undergoing a procedure involving or proximal to the central nervous system or spinal cord;
4. cardiac catheterization,
5. using 4 factor plasma concentrates
6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
7. platelet count less than 50,000/ul,
8. congenital coagulation disorders;
9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
10. women who are pregnant and;
11. unwillingness to consider blood transfusion.
A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles

This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles.

Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list.

For patients in the study group, in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle. For patient in the control group, a similar procedure would be performed on the same timing during the preceding cycles without entering the uterine cavity, ie endometrial biopsy catheter entering the endocervical canal without entering the endometrial cavity. All patients will then proceed to FET treatment in the next cycle as scheduled.

The FET would be carried out as per our protocol. In short, patients attend the clinic daily from 18 days before the next expected period for the determination of serum E2 and luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on which the LH level was above 20 IU/L and doubled the average of the LH levels over the past three days. For patients with irregular menstrual cycles or no ovulation demonstrated during natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two groups will be compared.

We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing FET treatment cycles
* Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at baseline
* endometrial thickness \>=8mm during the stimulated IVF cycle and FET cycle

Exclusion Criteria:

* Pregnancy in previous IVF or FET cycles
* Presence of hydrosalpinx not surgically corrected prior to FET
* Presence of endometrial polyp or fibroid distorting uterine cavity
* IVF cycles carried out for preimplantation genetic diagnosis
* Arrange for blastocyst transfer
* Use of donor oocytes
A Study to Evaluate Chang Gung Pneumothorax Detection Software

The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.

Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The case were over 20 years old and under 100 years old.
* DICOM format.
* Brand model of Canon.
* DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
* poster-anterior view(PA-view) of chest X-ray

Exclusion Criteria:

* The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
* The chest X-ray that are difficult to interpret due to poor image quality.
Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia

The aim of this study is to compare the postoperative analgesic effect of intrathecal dexmedetomidine combined with bupivacaine and midazolam combined with bupivacaine in high tibial osteotomy.

With more than 80% of patients experiencing acute pain following surgical procedures, and half of them reporting inadequate pain therapy, the control and management of post-surgical pain remains one of the most challenging aims of modern anesthesia.

Adequate postoperative pain control is an important part of postoperative care treatment. World Health Organization, as well as International Association for the Study of Pain, have emphasized its significance for patients well-being, and determined pain relief to be a human right and the occurrence of pain as fifth vital sign.

Local anesthetic, bupivacaine, is the most common agent used for spinal anesthesia but has relatively short duration of action. Many adjuvants to local anesthetics have been used intrathecally to improve the quality of intraoperative analgesia and prolong it in the postoperative period.

Diverse classes of drugs such as opioids , epinephrine , neostigmine , magnesium , midazolam , ketamine , and clonidine have been added to intrathecal local anaesthetics in an attempt to prolong analgesia and reduce the incidence of adverse events.

Opioids are commonly added to local anaesthetics to produce spinal and epidural anesthesia. However, significant adverse effects such as, urinary retention, respiratory depression, hemodynamic instability, pruritus and occasionally severe nausea and vomiting, may limit their use .

α2-adrenergic agonists are new neuraxial adjuvants being studied to improve the quality of subarachnoid blockade regarding both sensory and motor blockades. There are many studies supporting their efficacy as adjuvants individually.

Dexmedetomidine, a highly specific, potent, and selective α2-adrenergic agonist, provides stable hemodynamic conditions and good quality of intraoperative and prolonged postoperative analgesia with minimal side effects.

Discovery of benzodiazepine receptors in spinal cord in 1977 triggered the use of intrathecal midazolam for prolongation of spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-60 years.
* Gender: Both males and females.
* Scheduled patients for High tibial osteotomy under spinal anesthesia.
* American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

* Patient refusal
* Allergy to the studied drugs.
* Patients with contraindications to spinal anesthesia.
* Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases
* Coagulopathy or thrombocytopenia
* CNS diseases as epilepsy, stroke or psychiatric illness.
A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. Each session will be conducted on HIPAA-compliant Zoom and led by the PI (Dr. Gold).

This is a treatment development study that begins with an open non-randomized pilot trial (N = 10) in which we will test the manual developed for Future Self-BD by assessing the acceptability and feasibility of Future Self-BD. After completion of the non-randomized pilot trial and subsequent revisions to the Future Self-BD manual, we will conduct a parallel randomized controlled trial comparing Future Self-BD (N = 30) to a control treatment, Daily Check-Ins (N = 30). Future Self-BD and Daily Check-Ins involve six, weekly, 1.5-2 hour sessions and one 1.5 hour follow-up session one month after completion of the sixth session; thus, participants will be enrolled in the study for a period of 10 weeks. Assessments will occur at all study sessions.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or older
* Have a diagnosis of BD I or II
* Have a diagnosis of tobacco use disorder
* Be engaged in outpatient treatment with a medical provider
* Be on a stable dose of a mood-stabilizing medication
* Smoke an average of at least 5 cigarettes per day for the past 30 days at baseline (based on the Heaviness of Smoking Index(Heatherton et al., 1989))
* Be interested in quitting smoking
* Not currently or in the past 3 months be receiving smoking cessation treatment.

Exclusion Criteria:

* Current psychosis
* Intent to harm oneself with an associated plan and intent to act on suicidal thoughts
* Experiencing severe symptoms of depression and/or hypomania that may warrant a higher level of care (a Patient Health Questionnaire-9 total score ≥ 20(Kroenke et al., 2001) and/or an Altman Self-Rating Mania Scale total score ≥ 6(Altman et al., 1997) will trigger further clinician evaluation)
A Phase II/III Randomized Evaluation of Dose-escalation with Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)

This is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (RT) vs. hypofractionated, dose-escalated, esophageal-sparing (HD-ES) intensity modulated radiation therapy (IMRT).

We hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. This approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Intrathoracic tumour requiring palliative radiation, either for palliation of symptoms or prevention of progression that is expected to cause symptoms in the next 6 months (in the judgement of the enrolling investigator)
* Willingness and ability to provide informed consent
* Eastern Cooperative Oncology Group performance status 0-3
* Age 18 years or older
* Prior or planned systemic treatment (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist
* Concurrent palliative radiotherapy to other metastatic sites is permissible at the discretion of the treating radiation oncologist.
* Life expectancy greater than 3 months

Exclusion Criteria:

* Prior thoracic radiotherapy which, in the opinion of the treating of radiation oncologist, precludes the delivery of further thoracic radiotherapy. If there has been prior thoracic radiotherapy, a composite of all RT plans must be created, and the dose constraints herein must still be met. An allowance for 10 percent repair is permitted if at least 12 months have passed between the prior radiotherapy and the trial protocol specified radiotherapy.
* Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. This includes interstitial lung disease.
* Pregnant or lactating women
* Inability to attend the full course of radiotherapy or planned follow-up visits
Transconjunctival Needling Revision Versus Medical Treatment

When the glaucoma filtering surgery failures (intraocular pressure rises again), the options is start to use the hypotensive eye drops again (medical treatment). However, in some cases (encapsulated blebs), there is a simple surgical revision that can revival the primary failure surgery. It calls transconjunctival needling revision. In this study, the investigators compare the efficacy of this revision versus medical treatment in 12-month follow up in eyes with encapsulated blebs.

To compare the efficacy of transconjunctival needling revision (TNR) with 5-fluorouracil versus medical treatment (MT) in glaucomatous eyes with uncontrolled intraocular pressure (IOP) due to encapsulated bleb after trabeculectomy Prospective, randomized, interventional study. A total of forty eyes of 39 patients with elevated IOP and encapsulated bleb diagnosed at maximum 5 months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either TNR with 5-fluorouracil or MT (hypotensive eyedrops). A maximum of two TNR per patient was allowed in the needling arm. All eyes were followed up for 12 months. Success of treatment was defined as IOP ≤ 18mmHg and 20% reduction from baseline at last follow up.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with encapsulated blebs developed in 5 months or less following primary glaucoma filtering surgery (trabeculectomy) and intraocular pressure \>= 20mmHg

Exclusion Criteria:

* Previous other ocular surgery