cyrilzakka/clinical-trials huggingface dataset:
Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?

The purpose of the investigators is to determine the frequency of priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.

Priformis Syndrome is a neuromuscular disorder characterized by compression or irritation of the sciatic nerve under the piriformis muscle, tenderness in the piriformis muscle, and back, hip, and leg pain. The pain may radiate along the sciatic nerve trace in the gluteal region and posterior thigh. Diagnosis is based on clinical symptoms, specific physical examination findings, and positive response to local injection.

The diagnosis of piriformis syndrome is usually made only after lumbar spine pathologies are excluded. This traditional approach leads to underdiagnosis of piriformis syndrome. More than one cause may coexist in hip and/or leg pain.The existence of one cause does not exclude the other.Priformis syndrome should not be a diagnosis of exclusion.

In the differential diagnosis of hip and/or leg pain, physical examination to exclude piriformis syndrome and injection of local anesthetic into the piriformis muscle is much less invasive than surgery to confirm lumbar spine pathology and can be performed as an outpatient.Thus, early diagnosis and appropriate treatment process is accelerated. If there is an unfavorable response to the local injection, investigation for lumbar vertebral pathologies can be initiated.

The purpose of the investigators under this information and justifications is; To determine the frequency of Priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with unilateral hip and/or leg pain

Exclusion Criteria:

* no
A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients

The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.


Eligibility Criteria:
Inclusion Criteria:

1. Chronical ITP patients.
2. The subjects were diagnosed as ITP with bone marrow aspiration within 3 months before enrollment or in the screening period. And secondary immune thrombocytopenia (e.g., myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia) was excluded.
3. Patients had a mean platelet count of less than 30,000/µL in the screening period.
4. Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
5. Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have received a stable dose for at least 12 weeks.
6. Normal PT/INR and APTT.

Exclusion Criteria:

1. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
2. Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association \[NYHA\] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
3. Malignant disease
4. Cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
5. Patients with one of the following conditions should be excluded:

   * Treatment with immunoglobulins within 1 week preceding the first dose of study medication.
   * Treatment with splenectomy or rituximab within 12 weeks preceding the first dose of study medication.
   * Treatment with eltrombopag or Nplate within 4 weeks preceding the first dose of study medication.
   * Treatment with cyclophosphamide or vinca alkaloids within 4 weeks preceding the first dose of study medication.
6. ALT\>2×ULN，AST\>2×ULN，Total Bilirubin\>1.5×ULN，serum creatinine \>1.2×ULN，Total albumin \<0.9×LLN
Losartan for Patients With COVID-19 Not Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).


Eligibility Criteria:
Inclusion Criteria:

* Positive laboratory test for COVID-19 based on local laboratory standard
* Age greater than or equal to 18 years of age
* One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (\>101.5) or loss of taste / smell

Exclusion Criteria:

* Randomization \> 72 hours of meeting inclusion criteria
* Randomization \> 7 days of symptom onset
* Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
* Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema
* Pregnant or breastfeeding women
* Females able to have children not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate/Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study, condom use or abstinence during the study. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks.
* Patient reported history or electronic medical record history of kidney disease, defined as:

  1. Any history of dialysis
  2. History of chronic kidney disease stage IV
  3. Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 (must be have been measured within 1 month of enrollment)
  4. Other kidney disease that in the opinion of the investigator, would affect losartan clearance
* Patient reported dehydration and significantly decreased urine output in the past 72 hours
* Most recent systolic blood pressure prior to enrollment \<110 mmHg
* Patient reported history or electronic medical record history of severe liver disease, defined as:

  1. Cirrhosis
  2. History of hepatitis B or C
  3. Other liver disease that in the opinion of the investigator, would affect losartan clearance
  4. Documented AST or ALT \> 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record)
* Potassium \>5.0 mmol/L (must have been measured within 1 month) of enrollment
* Concurrent treatment with aliskiren
* Inability to obtain informed consent
* Enrollment in another blinded randomized clinical trial for COVID
Plasticizers and in Vitro Fertilization Outcomes

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women undergoing in vitro fertilization cycles
* Normal ovarian reserve (AMH \> 1.0 and AFC ≧ 5)

Exclusion Criteria:

* Daily homestay time \> 12 hrs
* Diminished ovarian reserve (AMH ≦ 1.0 or AFC\<5)
* Oophorectomy
* Gynecologic cancer patients
* Severe male infertility
Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study

Prospective interventional pilot study included children with septic shock, weight ≥ 10 Kgs and requiring continuous kidney replacement therapy. Cytosorb (CytoSorbents Inc, New Jersey, USA) cartridge was added to CKRT every 24 hours for a maximum of 96 hours. A control group of matched patients was also identified from an external database. The primary outcome of the study was the proportion of patients who achieved an equal or more than 50% relative reduction in vasopressors or inotropes dose from baseline to the end of treatment. Secondary outcomes included doses of vasopressors and inotropes, hemodynamic and biological changes, changes in severity scores and 28-day mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Children weighing ≥ 10 kg
2. Septic shock as defined by the International Pediatric Consensus Conference
3. Need for Continuous Renal Replacement Therapy (CRRT) = acute kidney injury defined by the KDIGO criteria (16) AND/OR fluid overload ≥ 10%

Exclusion Criteria:

* Refused consensus by parents
* Concomitant use of other extracorporeal blood purification techniques.
Prospective Pellevé™ Neck Wrinkle Study

Use of RF device to treat wrinkles of the neck

This is a prospective study evaluating the safety and efficacy of two treatments, spaced at 30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.

Eligibility Criteria:
Inclusion Criteria:

* 30-70 years of age
* Subjects with clinical evidence of neck wrinkles moderate to severe in severity as specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Willingness and ability to provide written photo consent and adherence to photography procedures(i.e., removal of jewelry and makeup).
* Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusion Criteria:

* Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
* Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study.
* Subjects who have had prior exposure to any botulinum toxin for rhytids in the treatment area in the 6 months preceding study enrollment through the duration of the study.
* Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment)within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography.
* Microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
* Active cut, wound, or infection on the skin.
* Oral Isotretinon within the past 12 months.
* Active HSV-1.
* History of keloids or hypertrophic scarring.
* Existing or history of skin malignancy in the treatment area during the past 12 months.
* Existing or history of skin disease in the treatment area during the past 12 months.
* History of collagen or vascular disease.
* Subjects who have implantable pacemaker, automatic implantable defibrillator/ cadioversor (AICD), or any other implantable electric device.
* Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics.
* History of autoimmune disease.
* History of any disease that inhibits pain sensation.
* History of Diabetes I or II.
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
* Subjects who anticipate the need for surgery or overnight hospitalization during the study.
* Subjects who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment or unreliability.
* Enrollment in any active study involving the use of investigational devices or drugs.
Sole-Therapy Treatment of Atrial Fibrillation

RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient between 18 and 80 years of age
2. Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:

   * Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
   * Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
   * Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
3. Left Atrial Size \< 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
5. Patient is willing and able to provide written informed consent.
6. Patient has a life expectancy of at least 2 years.
7. Patient is willing and able to attend the scheduled follow-up visits.
8. Weight \< 325 lbs

Exclusion Criteria:

1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
2. Prior cardiac surgery
3. Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
4. Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
5. Cerebrovascular accident within previous 6 months
6. Known carotid artery stenosis greater than 80%
7. Evidence of significant active infection
8. Patient unable to undergo TEE
9. Pregnant woman
10. Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
11. Presence of thrombus in the left atrium
12. Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
13. Patient is enrolled in another investigational study
The Efficacy of the Administration of Fibrinogen in Liver Transplantation

Objective:

* To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.
* To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.
* To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.

Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:

Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.

Placebo group, to whom the same dose volume of saline will be administered.

Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for liver transplantation
* Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.

Exclusion Criteria:

* Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.
* Known history of thromboembolic events in 30 days
* Known or suspected pregnancy
* Previous randomization in this trial
* Known or suspected allergy to trial products or related products
* Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin
* The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome
* Heart beating donors and living donor
* Patient reluctant to participate in the trial
Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation

The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm inactivity. These changes in muscle properties result in a decrease in the force generating capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing and a subsequent prolonged weaning process or failure. A prolonged weaning period is associated with longer duration of MV, which may result in a cascade of further diaphragm dysfunction, weakness, and injury.

Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation. However, neither study provided optimal stimulation settings. As such, the primary purpose of this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation to induce diaphragm contraction.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Age: 18 - 35 years
* Non-smoking
* Healthy
* Able to communicate in English
* Normal lung function
* Normal Body mass index between 18.5 and 24.9 kg/m2
* Willingness to adhere to the study rules

Exclusion Criteria:

* Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular, neuromuscular, gastrointestinal or muscle system
* Women who are pregnant or breast feeding or have the intention to become pregnant during the course of the study
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Known or suspected non-compliance, drug or alcohol abuse
* Intake of medication affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system or gastrointestinal or muscle system
* Presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
* Any metal or electronics inside of the body
* History of seizures or epilepsy
* Tattoos on the stimulation sites
* Previous enrolment into the current study
Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in and completed the primary study through the Day 28 visit.
* Received at least one dose of study drug in the primary study
* Able to give written informed consent prior to completion of the primary study

Exclusion Criteria:

* Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
* Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
* The Principal Investigator considers that the subject should not participate in the study
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
* Prior treatment must have been completed at least 4 weeks prior to enrollment
* No untreated primary or metastatic brain or meningeal tumors
* ECOG PS 0 or 1
* Meet all screening laboratory values

Exclusion Criteria:

* History of severe hypersensitivity reactions to other monoclonal antibodies
* Active autoimmune disease or a documented history of autoimmune disease
* Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
* Active infection
* Concurrent medical condition requiring the use of immunosuppressive medications
Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients

The primary objective is to establish the safety of the CO-rebreathing method for measuring total blood and plasma volume in CAD patients. The working hypothesis is that the CO-rebreathing method is safe in use with coronary artery disease patients and that it does not cause myocardial ischemia or cardiovascular damage.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease
* Stable COPD
* Optimal medication

Exclusion Criteria:

* Unstable disease
* co-morbidities