cyrilzakka/clinical-trials huggingface dataset:
Measuring Effectiveness in Sleep Apnea Surgery

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.

Eligibility Criteria:
Inclusion Criteria (Surgical Group)

* Unable to tolerate PAP, supported by statement from sleep physician
* Multilevel airway obstruction
* Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension)

Inclusion Criteria (Comparison Group-PAP)

* Tolerance of PAP during titration study and indication of willingness to use
* No previous treatment of PAP except during titration study
* Washout period of two weeks between PAP titration study and study assessment
* Matched to surgical group patient on age, gender, race, body mass index, and OSA disease severity (apnea-hypopnea index)

Exclusion Criteria:

* Pregnant women
* Primary snoring or mild OSA (apnea-hypopnea index \< 15)
* Known neurologic, cardiac, hepatic, or renal disorder
* Acute illness or infection
* Co-existing sleep disorder other than primary snoring
* Unable to fast overnight prior to blood draw
Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs

The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb status, clinical status (Rutherford classification) and pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).

The investigators will conduct a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who are not eligible for conventional surgical or endovascular therapies. The investigators intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections with either BM-MSC (30 injection sites with 5\*10\^6 MSCs each) or placebo in the lower leg of the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering mortality, limb status, clinical status (Rutherford classification) and changes in pain score, will be assessed at six months.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Severe Peripheral Artery Disease (PAD; Fontaine class III and / or IV):

  * Fontaine III (Rutherford 4): persistent, recurring rest pain requiring analgesia
  * Fontaine IV (Rutherford 5): non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies
* Ankle brachial index \< 0.6 or unreliable (non-compressible or not in proportion to the Fontaine classification)
* Not eligible for surgical or endovascular revascularization
* Written informed consent.

Exclusion Criteria:

* History of neoplasm or malignancy in the past 10 years
* Serious known concomitant disease with life expectancy of less than one year
* Rutherford 6 in which amputation on the short term (within 1-2 weeks) is inevitable
* Pregnancy or unwillingness to use adequate contraception during study
* Uncontrolled acute or chronic infection with systemic symptoms
* Follow-up impossible.
Biological Standardization of Secale Cereale Allergen Extract

The objective of this study is to determine the biologic activity of a Secale cereale allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Secale cereale allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
2. Subject can be male or female of any race and ethnic group.
3. Age \> 18 years and \< 50 years at the study inclusion day.
4. Positive skin prick test with a standardized commercially available preparation of Secale cereale allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
5. A positive test for specific IgE to Secale cereale (CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
6. Allergic symptoms during the pollen season of Secale cereale.
7. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria:

1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent).
4. Pregnancy.
5. Dermographism affecting the skin area at the test site at either study visit.
6. Atopic dermatitis affecting the skin area at the test site at either study visit.
7. Urticaria affecting the skin area at the test site at either study visit.
8. Participation in another clinical trial within the last month.
9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension, ..)
Laparoscopic Versus Open Pyeloplasty for Treatment of UPJO in Children.

Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay

Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Indications for surgical intervention include impaired split renal function (\< 40%), a decrease of split renal function of \> 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on US, and grade III and IV dilatation as defined by the Society for Fetal Urology. The open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. Schuessler et al. introduced the first laparoscopic pyeloplasty (LP) 1993 followed by Peters et al, who performed the first pediatric laparoscopic pyeloplasty. Since then, minimally invasive pyeloplasty (MIP) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in UPJ obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. The high cost and long learning curve hindered generalization of MIP in all centers. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . Tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . Till now 85% of infants are still treated with open pyeloplasty . According to the EAU guidelines 2023 "There does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " .

Most of the studies that compared open to LP didn't limit cases to mini-incision open pyeloplasty.

To our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.

Eligibility Criteria:
Inclusion Criteria:

* Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else

Exclusion Criteria:

* Recurrent UPJ obstruction.
* Cases that require technique other than dismembered pyeloplasty
* Patients that have contradiction to laparoscopy.
* comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity
* patient refusing participation in the study.
VHAG in Treating R/R T-ALL/LBL

Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recurrence of ALL patients. In addition, most relapsed T-ALL/LBL patients relapse during first-line treatment. Once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.

This is a prospective, single-arm, phase II and open-label study. A total of 50 R/R T-ALL/LBL participants will be enrolled. The primary endpoint is complete remission with or without peripheral blood cell recovery. The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF. The purpose of this study is to explore efficacy of the VHAG in the treatment of R/R T-ALL/LBL patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification; 2. Age ≥ 14 years,\<75 years; 3. Clincally diagnosed as relapsed or refractory T-ALL/LBL; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Expected survival time ≥ 2 months; 6. No organ dysfunction that would restrict the use of this protocol during the screening period; 7. Understand the study and sign the informed consent form.

Exclusion Criteria:

* 1. Patients with known central nervous system (CNS) involvement of T-ALL/LBL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.) 3. Cardiac ultrasound LVEF \< 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.
Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.


Eligibility Criteria:
Inclusion Criteria:

1. Provides written informed consent before any assessment is performed
2. Is male or female aged ≥18
3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
4. Has achieved SVR24
5. Is able to comply with the visit schedule

Exclusion Criteria:

1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
2. Use or planned use to start a new course of hepatitis C therapy.
3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
Comparative Study of Three Common Bile Duct Closure Techniques

This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.

At present, the commonest available options for CBD closure include repair over T-tube drain, primary closure, and repair after antegrade biliary stenting. All three methods present speciﬁc technical performance features, require different postoperative management protocols, and are charged with speciﬁc morbidity related to the procedure and therefore should not be considered the same procedure in the context of CBDE.

Repair over T-tube is the traditional surgical technique. It has many advantages as post-operative distal CBD decompression, trans-tubal cholangiography, and availability of retained CBD stones extraction. However, it has several potential complications up to 10% of patients. The most frequent complications are bile leakage, tract infection, T-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. It also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. Primary closure of CBD has been described in the literature to overcome these adverse consequences of the T-tube. However, it has many potential complications as a potential bile leak and CBD stricture, which may occur due to papillary edema and insufficient bile duct expansion. There are conflicting results regarding significant differences in the morbidity and mortality between primary closure and T-tube drainage. There is no conclusive evidence displaying whether primary closure is better or worse than T-tube drainage after CBD exploration.

Using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. Although there are some available drainage options after CBDE, a consensus on the optimal drainage is yet to be reached.

Eligibility Criteria:
Inclusion criteria

* CBD stones
* age from 20 to 80,
* CBD \> 0.8 cm and \< 2.5 cm,
* American Society of Anesthesiologists (ASA) grade I, II or III,
* agreement to randomization and complete the study requirement. Exclusion criteria
* acute suppurative cholangitis,
* acute biliary pancreatitis,
* biliary malignancy,
* biliary malformation,
* distal CBD stenosis and or obstruction,
* trans-cystic stone extraction,
* explorations followed by choledochojejunostomy and choledochoduodenostomy.
LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study

The purpose of this research study is to see if a special CT scan (dual-energy CT) provides useful information in patients undergoing bronchsoscopic lung volume reduction (valve placement for emphysema). The investigators will enroll up to 30 participants in this study from University Hospitals Cleveland Medical Center. All of the participants from this study will undergo their valve procedure at University Hospitals Cleveland Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age at the time of written informed consent) with emphysema who have been deemed appropriate candidates for bronchoscopic lung volume reduction

Exclusion Criteria:

* Patients unable to provide consent
* Patients who are pregnant or nursing
* Women of child-bearing age will undergo pregnancy tests based on University Hospital (UH) standard bronchoscopy pre-procedural testing
* Patients unable to undergo a DECT chest (contraindications to a CT chest with intravenous contrast such as a reported or documented allergy to intravenous (IV) contrast or impaired renal function, defined as the following:
* Glomerular filtration rate (GFR) \<90 ml/min/1.73 m2 at the time of initial evaluation if patient age is ≤ 59 years
* GFR \<85 ml/min/1.73 m2 if patient age is 60-69 years
* GFR \<75 ml/min/1.73 m2 if patient age is ≥70 years
Recruit Blood Donors Via SMS During Epidemic of COVID-19

The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. Urgent recruitment of blood donors is therefore planned during the period from 30 April to 10 May via emergency recruitment SMS . This study has been designed to compare which information extraction frameworks would be more sensitive to blood donors in emergency situations.

Researches has showed that that the information extraction and processing in emergency was different from the normal situation. To understand what information the blood donors are more sensitive to in an environment that may pose a potential threat to themselves, this interventional study has been designed. Eligible blood donors in Guangzhou Blood Center has been randomly divided into four groups according to their sociological variables, their interval since last blood donation , their history donation times and the location of their last blood donation. Three groups of donors has been randomly selected as interventional groups, and will receive three kindly of emergency blood donor recruitment SMS respectively. The placebo group donors will only receive a May Day greeting SMS.

One blood donor recruitment SMS will emphasize what blood services will do to ensure the safety of blood donors during their donation in 2019-nCoV epidemic, one will shows information about a loss-based framework, while the third one will show information about a benefit-based framework .

Eligibility Criteria:
Inclusion Criteria:

* blood donors whose last turning up were between October 31, 2016 to October 31, 2019

Exclusion Criteria:

* Blood donors who were deferral by blood screening result and other situations. Blood donors who have indicated that they would not accept urgent recruitment.
Trendelenburg's Slide Prevention Study

The purpose of this study is to compare two cushioning materials (a gel mattress and an egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent patients from sliding toward the head of the bed during head-down positioning.

Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (\<2 inches) on average.

Patient undergoing laparoscopic gynecologic surgery are often placed in steep (30 to 45 degrees) Trendelenburg's (head lower than feet) position. This helps the bowels to move towards the patient's head, making surgery in the pelvis safer. During surgery, if patients slide a great deal toward the head of the bed, nerve injury and hernia risk may be increased. Several techniques are in use to prevent patients from sliding on the bed during surgery, and of these, increasing the friction between a patient's skin and the bed surface appears to be the safest technique. Two materials are in use to increase this friction: a gel pad or an egg-crate foam mattress upon which the patient lies with bare skin. This study is comparing these two materials to see which material is associated with the LEAST amount of patient slide. Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (\<2 inches) on average.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing gynecologic laparoscopic or robotic-assisted laparoscopic surgery
* Trendelenburg's position is planned
* General anesthesia is planned

Exclusion Criteria:

* Patients with intolerance of Trendelenburg's position
* Patients whose surgery are converted to laparotomy
Single Blinded First CMC Osteoarthritis Treatment

Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1-3 osteoarthritis of the basal joint

Exclusion Criteria:

* Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
* Patients who have received a corticosteroid injection in the last year to the 1st CMC joint on the proposed study side
* Patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis
* Patients who have concurrent DeQuervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months
* Patients undergoing evaluation of cervical radiculopathy
* Patients with fibromyalgia or inflammatory rheumatic disease
* Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
* Patients with any history of primary or secondary bone tumor
* Patients that are pregnant or terminally ill