cyrilzakka/clinical-trials huggingface dataset:
A New Birth Weight Prediction in Chinese Population

To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.

A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.

Exclusion Criteria:

* The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.
Obliterating Diabetic Microangiopathy of the Diabetic Foot

The purpose of this study will be the assessment of microangiopathy determined by the increase of capillary basement membrane thickness and decrease of capillary lumen area in the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients

Primary endpoint of the study is to quantitatively evaluate the presence of microangiopathy as increase of capillary basement membrane thickness and decrease of capillary lumen area determined by transmission electron microscopy analysis in type 2 diabetic patients with only motor-sensory neuropathy or chronic critical ischemia affected by foot ulcer.

The following parameters will be evaluated:

* presence of capillary (n/mm2) and thrombosis (%) and correlation of this quantitative histological data with ischemic parameters (TcPO2, ankle-brachial index) and risk of diastasis
* correlation between presence of inflammatory infiltrate (leukocytes/mm2) with blood inflammatory parameters (erythrocyte sedimentation rate (ESR), C-reactive protein, alpha-2 globulin)
* rate of diastasis and/or time required for recovery associated with histopathological data
* presence of acanthosis related to clinical and demographic variables

Eligibility Criteria:
Inclusion Criteria:-

* adult type 2 diabetic patients of either gender
* diabetes for more than 10 years
* motor-sensory diabetic neuropathy with or without chronic critical ischemia
* local residents
* ulcer with surgical therapy indication of removal the 1st ray because of gangrene or osteomyelitis

Exclusion Criteria:

* type 1 diabetic patients
* diabetes for less than 10 years
* renal replacement therapy
* urgent surgical procedure for sepsis
* immunosuppressive therapy
* not local residents

  * Cancer with adverse prognosis in months, or chemotheraputic treatment
  * Ongoing or planned pregnancy
  * Lack of consent to participate to the study
Comparison of TOT 8/4 Versus TOT 6/3

Transobturator tapes (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

Retrospective studies demonstrated that the distance between urethra and suburethral sling can vary considerably between 1 mm and 10 mm. In order to standardize the placement of the suburethral sling we choose two different distances between urethra and sling.

Transobturator tape (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final fixation of the sling and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

According to the used Hegar dilator sounds two different techniques are used:

TOT 8/4 or TOT 6/3.

Eligibility Criteria:
Inclusion Criteria:

* urinary incontinence

Exclusion Criteria:

* previous TOT or TVT
Cytokine Status of Covid-19 Patients

COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In the studies, the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and TNF-α, were evaluated. In addition, blood values of a limited number of cytokines were investigated similarly in a limited number of studies published in our country.

The causative agent of coronavirus 2019 (COVID-19) disease, which started in Wuhan province of China in December 2019, was severe acute respiratory failure syndrome coronavirus 2 (SARS-CoV-2), which quickly spread all over the world and caused a pandemic. COVID-19 can cause death with symptoms such as fever, cough, muscle pain, shortness of breath, and pneumonia (1). Pulmonary pathology of COVID-19 is diffuse alveolar damage, focal reactive hyperplasia of pneumocytes with patchy inflammatory cells, intravascular thrombosis, monocyte, macrophage and lymphocyte infiltration into pulmonary spaces. Severe infiltration of pulmonary tissue affects alveolar gas exchange. In addition, cardiovascular morbidity, tachyarrhythmia and thromboembolic events are observed in 1/5 of the hospitalized patients with troponin elevation, which is closely related to mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In the studies , the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and TNF-α, were evaluated. In addition, blood values of a limited number of cytokines were investigated in a similar way in a limited number of studies published in our country.

We aimed to study IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 at Covid 19 and healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Covid 19 PCR (+) results

Exclusion Criteria:

* Cancer Patients
* Patients with known immunodeficiency
* Pregnancy
Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* BMI under 35
* normal liver enzymes
* no bile duct dilatation in ultrasound
* cholecystolithiasis

Exclusion Criteria:

* NSAID allergy
* previous upper gi-surgery
* common bile duct stones in preoperative imaging
* history of severe acute pancreatitis
The Complete® Self-Expanding Stent and Stent Delivery System Registry

The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Eligibility Criteria:
Inclusion Criteria:

* The lesion(s) is either de-novo or restenotic in nature, located in either the common iliac artery or the external iliac artery and is \>50% stenosed
* Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent diameters of 6.0 - 10.0mm
* Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a lesion stenosis ≥50% with an Ankle Brachial Index (ABI) \< 0.90 or Toe Brachial Index (TBI) \<0.80 or an abnormal Pulse Volume Recording (PVR);
* Total lesion length is \< 110 mm;

Exclusion Criteria:

* Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;
* Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;
* Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
* Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;
* Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;
* Inadequate distal run-off;
* Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure;
* History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
* Platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or White Blood Count (WBC) \<3,000 cells/mm3;
* Creatinine \>2.0 mg/dl;
* Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;
Cervical Stairstep and Effects on Range of Motion (ROM)

Observe the effects of Cervical Stairstep on Cervical Spine Range of Motion

The cervical spine can be affected in a number of ways due to its vulnerability to injury. These injuries can result from poor posture, sports or occupation and can lead to degenerative changes. Cervical range of motion (ROM) is also affected by these injuries. When active ROM is restricted, the injury is of muscular origin. Pain with passive ROM indicates ligamentous injury whereas restricted passive ROM indicates blockage within bone or soft tissue. The normal range of motion in the cervical spine is 80-90 degrees flexion, 70 degrees extension, 20-45 degrees lateral flexion and 90 degrees of rotation. A common mechanism of cervical spine injury is axial loading. Axial loading can create a buckling effect within the cervical spine and decrease its ability to move normally, creating a limited ROM.

Eligibility Criteria:
Inclusion Criteria:

* students and faculty between ages 18 and 50

Exclusion Criteria:

* current neck pain (as measured by the Neck Disability Index (NDI) and utilizing Jackson's and maximal foraminal compression tests to assess for radiating symptoms)
* severe recent head trauma
* acute exacerbations within the past 3 months
* known cervical disc problems
* surgical fusions within the cervical spine
* highly acute symptoms
* a positive valsalva test
* seizure disorder
* analgesics
* muscle relaxants
* medications with effects on the musculoskeletal system
* chiropractic manipulation within 48 hours of the study
* Other exclusions can be made based on investigator judgment
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)

That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.
3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
4. Patient willing to give informed consent and follow study protocol.

Exclusion Criteria:

1. Wake resting SpO2 \< 90%
2. Patient requires BiLevel PAP or supplemental oxygen
3. The patient is medically unstable (e.g. respiratory or cardiac failure)
4. Patient unwilling to give informed consent or follow study protocol.
Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura

The interpretation of platelet counts has to be revaluated in the light of caplacizumab. By effectively blocking platelet binding sites on VWF-multimers, the nanobody leads to a rapid normalization of the platelet count within 3 to 4 days. Most importantly, caplacizumab uncouples platelet counts from ADAMTS13 activity and thereby launches unprecedented thrombocyte dynamics, with potential pitfalls for over- and undertreatment.

A relevant number of patients responds to caplacizumab with a brisk increase in platelet count, followed by a marked dip of platelets (patient on the left). This may mislead treating physicians into re-intensifying therapy, with a respective risk for adverse side-effects and complications. Taken together, these observations call for reliable descriptions and the identification of predictive parameters to predict the platelet response upon administration of caplacizumab in a large patient cohort. Here, PREDICT-2020 is designed as a retrospective study to specifically address the following aspects:

* Identifying and describing clusters of platelet responses to caplacizumab
* Identifying potential pitfalls for treating physicians
* Predicting the individual thrombocyte response
* Correlating platelet responses with individual patient outcome


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of autoimmune thrombotic thrombocytopenic purpura
* Treatment with at least a single dose of caplacizumab, either i.v. or s.c.
* Male or female patients older than 18 years of age

Exclusion Criteria:

* Hereditary thrombotic thrombocytopenic purpura
Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain

The main aim of this study is to investigate the effects of dry cupping on calf muscle trigger points in patients with plantar heel pain. A secondary aim is to examine the correlation between several outcome measures in those patients.

Plantar heel pain is a condition often seen by healthcare providers. It is presented as pain and tenderness under the heel with weight bearing activities. Approximately 15% of athletic and non-athletic adults who have foot complaints seek professional care for plantar heel pain. There are different names and definitions for this condition in the literature such as plantar heel pain, plantar fasciitis, plantar fasciosis, plantar fasciopathy, heel spur syndrome, and jogger's heel. The reason for inconsistency in defining the condition is due to disagreement on the underlying pathology. A number of conditions may result in plantar heel pain, namely plantar fasciitis (most common), calcaneus fracture, heel fat pad atrophy, and peripheral nerve dysfunction. Recently, several studies have shown that myofascial trigger points (MTrPs) or tender points in the calf muscles may be associated with plantar heel pain. Many studies have determined risk factors in the development of plantar heel pain, classifying them as either intrinsic or extrinsic. Intrinsic risk factors comprise the anatomical (ROM of the ankle and subtalar joints position) or demographic characteristics of the individual (age, gender, weight and height). Extrinsic risk factors are related mainly to the subject's activity environment, such as running on a hard surface, time spent weight bearing, and previous injury. All these factors lead to an increase in the mechanical load on the foot, specifically the plantar fascia. Treatment of plantar heel pain usually targets the plantar fascia or other structures in the plantar heel area using several interventions such as cortisone injection, therapeutic ultrasound, laser, ice, heel pads, and night splints. Evidence varies regarding the effectiveness of these interventions.

The main aim of this study is to investigate the immediate and carry-over effects of dry cupping on calf muscle trigger points on pain and function in patients with plantar heel pain.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral plantar heel pain.
* Trigger point(s) in the gastrocnemius/soleus muscle(s).
* Central or centro-medial tenderness in the plantar aspect of the heel.

Exclusion Criteria:

* Red flags: tumor, fracture, rheumatoid arthritis, osteoporosis, or any severe vascular condition in the lower limbs.
* Neurological symptoms: sciatica, tarsal tunnel syndrome.
* Previous surgery in the affected leg below the hip.
* Fibromyalgia.
* Previous manual therapy treatment for the same condition within the past 6 months.
* History of more than three corticosteroid injections within the past year.
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.


Eligibility Criteria:
Inclusion Criteria:

* Are age 6 to 21 years
* Provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable
* Have a history of symptomatic reactivity to cow's milk (i.e. Eczema, urticaria, upper or lower respiratory symptoms, GI disturbances, other rash or oral symptoms)
* Have a positive skin prick test (defined as wheal 3 mm ≥ negative control) and cow's milk- immunoglobulin E (IgE) \> 0.35 kilo Immunoglobulin Units (kIU)/L
* Have a positive OFC to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein).
* Are using appropriate birth control if subject is female and of child bearing age.
* Have self-injectable epinephrine (ie. EpiPen® or EpiPen Jr.®) available at home

Exclusion Criteria:

* Have a history of severe anaphylaxis defined as hypoxia (cyanosis or SpO2 ≤ 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence
* Have a history of intubation related to asthma
* Tolerate more than 184 milligrams of intact cow's milk protein at initial OFC
* Are pregnant or lactating
* Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of OFC (OFC needs to be rescheduled)
* Have pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
* Are currently taking greater than medium dose inhaled corticosteroid (\>400 mcg/day fluticasone or fluticasone equivalent if ≤ 12 years old or \> 600 mcg/day if \> 12 years old)
* Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
* Have used systemic corticosteroids within 4 weeks prior to baseline visit
* Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyome (ACE) inhibitor or tricyclic antidepressant therapy
* Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)
* Have participated in any interventional study for treatment of a food allergy in the past 12 months
* Have a severe reaction at initial DBPCFC, defined as either:

Life-threatening anaphylaxis, or Reaction requiring hospitalization
Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by procedure time, during an electrical procedure/study of the heart .

Transseptal puncture is a commonly performed procedure allowing access to the left atrium for catheter ablation. Historically, a conventional Brockenbrough needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature.1, 2 Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.3, 4

Previous studies have evaluated the feasibility and safety of radiofrequency (RF) energy applied to a conventional needle as a technique to access the left atrium, particularly in patients with a repeat procedure, fibrotic septum or aneurysmal septum.5, 6 As a result of this earlier work, a special proprietary device has been designed. The NRG RF needle (Baylis Medical Inc., Montreal, Canada), uses radiofrequency energy emitted from the needle tip to aid in transseptal access. Despite limited literature to support its superiority and safety7-9compared to the conventional approach, the new device has become adopted in some electrophysiology procedures involving a transseptal puncture.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach
* Patients greater than 18 years of age

Exclusion Criteria:

* Patients unable to grant informed, written consent