cyrilzakka/clinical-trials huggingface dataset:
Application of 3D Printing Guide Plate in Endoscopic Spinal Surgery

Application of 3D printing guide plate in endoscopic spinal surgery

This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgeries, in patients with low back pain, lumbosacral radicular pain, abnormal sensation or muscle strength or reflex of lower extremity, cauda equina syndrome, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

This study involved diseases such as lumbar disc herniation, lumbar spinal stenosis, radiculopathy, disc degeneration, etc. Endoscopic spinal surgeries are effective treatments for these disease. Needle Puncture is the key technology in endoscopic spinal surgeries.

In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.

The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT or evoked pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Pain lasting ≥12 weeks;
3. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications;
4. Pain intensity≥4 out of 10 on the numerical rating scale (NRS);
5. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features;
6. Agree with endoscopic spinal surgeries.

Exclusion Criteria:

1. Patient refusal to participate in the study;
2. Pregnant or nursing;
3. Allergies to local anesthetics, contrast dyes or steroids;
4. Significant anatomic deformity (either congenital or acquired) making it difficult to access the target as evidenced by computed tomography/magnetic resonance imaging;
5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;
6. Systemic infection;
7. Injection site infection;
8. Unstable medical or psychiatric condition;
9. Unable to tolerate the surgeries.
The Safety and Efficacy of Epidural Oxycodone

There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.

In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.


Eligibility Criteria:
Inclusion Criteria:

* Planned gynecological lower abdomen surgery with epidural pain treatment
* Informed consent obtained

Exclusion Criteria:

* Planned surgery under regional anesthesia
* contraindication to the study drug
* contraindication to the lumbar puncture
* Contraindication to oxycodone
* Pregnancy or lactation
* no informed consent
A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice

This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety Update Report", which is to be regularly sent to the European Medicines Agency (EMEA) and the responsible German Higher Federal Authority (BfArM).

Female subjects with distinctive follicle stimulating hormone (FSH) and LH deficiency require both FSH and LH. Until now these subjects were treated either with a combination of two recombinant preparations (r-hFSH and r-hLH) or else with a menotropin preparation, composed of urinary human FSH (u-hFSH) and human chorionic gonadotropin (hCG) as LH-replacement.

In Pergoveris™ for the first time both hormones FSH and LH are available as recombinant produced hormones in a combination preparation.

Pergoveris has both hormones i.e. FSH and LH available as recombinant produced hormones in a combination preparation in the ratio 2:1. This study is planned to record data for the stimulation not only in case of the ovarian stimulation with intercourse for the optimum (VZO) but also the intrauterine insemination (IUI) and the ovarian stimulation for the assisted reproduction \[in-vitro fertilisation (IVF) and intracytoplasmatic sperm injection (ICSI)\] in subjects with severe FSH and LH deficiency and learn more about this subject group and the applied stimulation plan.

Apart from the demographic data, anamnestic details e.g. reason for the infertility, duration of the unfulfilled wish for children, past medical treatment for conception and accompanying illnesses will be documented. The duration of the stimulation with Pergoveris as well as the dose per day will be recorded from the cycle documentations. Follicle sizes and hormones will be documented in accordance with the respectively carried out cycle monitoring. The result of the treatment is related to the number of cycles with ovulation stimulation using hCG, the number of the cycles with puncture, the number of the cycles with embryo transfer, the number and quality of the ova and embryos, on occurred pregnancies and documented abortions. Multiple pregnancies and births will also be recorded.

OBJECTIVES

* To find the reason for the diagnosis of the severe LH deficiency such as e.g. low endogenous LH, amenorrhea, low endometrial thickness or low estradiol level.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects undergoing stimulation with Pergoveris for the ovarian stimulation with VZO or with IUI or in preparation for a technology of the assisted conception such as IVF or ICSI

Exclusion Criteria:

* Subjects receiving combination cycles with clomifen, follitropin beta, urinary FSH, urinary human menopausal gonadotropin (hMG)
Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital

Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO) synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of adherence to treatment .

Anemia is one of the most important complications that affects morbidity and mortality in chronic kidney disease (CKD) patients. It has significant impacts on those patients such as fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and physical activity, growth retardation and decreased cognitive functions, left ventricular hypertrophy, and congestive heart failure So, proper management of anemia is very important .


Eligibility Criteria:
Inclusion Criteria:

* (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.

Exclusion Criteria:

* Children who have no other co existent hematological disorder .
PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, the strategies for graft-versus-host disease (GVHD) prophylaxis mainly include ex vivo and in vivo T-cell depletion (TCD) in haploidentical HSCT (haplo-HSCT). In vivo TCD modalities have become mainstream including granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols. The ATG strategy has been widely used. Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. In addition, infections, especially viral infections, remain an important drawback of this strategy. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* A patient age of 18-65 years
* Haploidentical hematopoietic stem cell transplant recipient
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Zimmer Trabecular Metal Total Ankle PMCF

The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

The study design is a prospective, multicenter, study of the commercially available Zimmer Trabecular Metal Ankle semiconstrained implants. The study will require each site to obtain Institutional Review Board approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. Follow-up surveys will occur at 4, 6, 8, and 9 years.

Eligibility Criteria:
Inclusion Criteria:

* The patient is \> 18 years of age
* The patient is skeletally mature
* The patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis.
* The patient is willing and able to provide written informed consent
* Patient is willing and able to cooperate in the required post-operative therapy
* The patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the Informed Consent
* The patient has participated in the Informed Consent process and has signed the Institutional Review Board/European Commission approved Informed Consent

Exclusion Criteria:

* The patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant.
* The patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery.
* The patient has a local/systemic infection that may affect the prosthetic joint
* The patient has a previous history of infection in the affected joint
* The patient is known to be pregnant
* The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease)
* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials
* The patient is unwilling or unable to give consent or to comply with the follow-up program
Cervical Vagus Nerve Block Prevents Ocularvagal Reflex

In ophthalmic surgery, surgical operations such as pulling certain eye tissues or compressing the eyeball often leads to bradycardia, arrhythmia even cardiac arrest, bradypnea, nausea and vomiting and elevated blood sugar level. The condition is called the ocularvagal reflex (OVR). Traditionally, when the bradycardia or arrhythmia happens, the operation has to be suspended, and atropine or isoproterenol is given intravenously to treat the bradycardia. Vagus nerve block may be an effective way to prevent and alleviate this vagal reflex. However it is difficult to perform the nerve block with anatomical landmark (blind) methods. In this study, the investigators used ultrasound-guided right cervical vagus nerve block to reduce the incidence of the OVR. The researchers hypothesized that low concentrations of lidocaine or ropivacaine can block the right cervical vagus nerve and reduce the incidence of intraoperative OVR. Researchers evaluated the changes of heart rate, blood pressure, oxygen saturation, and airway pressure in patients undergoing high-risk OVR surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients received surgeries with high-risk OVR, including the strabismus surgery, the posterior scleral reinforcement, and the insertion of ocular implant.

Exclusion Criteria:

* Those who have pre-existed vocal cord damage before surgery (such as hoarseness, electronic laryngoscopy shows fixed vocal cords or arytenoid cartilage dislocation).
* Those with a history of surgery on the both sides of the neck (eg, thyroidectomy, carotid endarterectomy).
* American Society of Anesthesiologist (ASA) Grade \> 3
* Patients with infection at the neck puncture site, or severe coagulation abnormalities before surgery, or a history of local anesthetic allergy, or who have a pacemaker.
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.

A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants of 2 months of age
* The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
* Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
* Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
* Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
* Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
* Axillary temperature ≤37℃

Exclusion Criteria:

* Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
* Patients with fever or acute disease.
* Have thrombocytopenia or hemorrhagic diseases
* Patients undergoing immunosuppressive therapy or immunodeficiency
* Have uncontrolled epilepsy or other progressive neurological disorders
* Other situations that the investigator consider as non-eligible
CFTR Related Pancreatitis Study

The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age : 4 years and older
* Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis
* History: at least one of the following:

  1. Carry one or two CFTR mutations
  2. Borderline sweat chloride levels
  3. Has Family History of CF
  4. Has had positive CF Newborn screening

     Exclusion Criteria:
* Pregnant females: will be excluded at screening.
Cardiovascular Risk Factors in a Cohort of Latina Women

To conduct a cross-sectional study of cardiovascular risk factors in a cohort of Latina women.

BACKGROUND:

Cardiovascular disease (CVD) is the leading cause of death among Latina women (LW) in the United States. Nursing knowledge in the area of CVD and Latina women is currently underdeveloped. Most studies have included Mexican women with limited information on how predictors such as resources, situational, personal, and demographic factors have an effect on the CVD-related dietary practices, physical activity, and exercise practices among Latina women subgroups such as Central American women.

DESIGN NARRATIVE:

To conduct a cross-sectional and follow-up preliminary intervention study in order to describe and analyze the CVD-related diet, physical activity, and exercise practices predictors in 221 Mexican and Central American women recruited from six counties in Northern California. Face-to-face interviews were conducted with Mexican American and Central American women (ages 40-75) who had at least one risk factor for CVD to answer the following questions: What were the CVD-related risk factors, dietary practices, physical activity, and exercise behaviors in Mexican and Central American women who were 40 to 75 years and who had at least one risk factor for CVD? What was the relationship between predictor variables (resources, situational, personal, and demographic factors) with CVD-related diet practices, physical activity, and exercise behaviors (outcome variables)?, and what were the short and intermediate-term effects of a cardiovascular nursing intervention on diet, physical activity, and exercise? A sample of 221 women was targeted. Data were collected during the first two years of the project to provide substantial research-based information to develop a cardiovascular nursing intervention to support Latina women efforts to promote heart health and prevent CVD. Data were analyzed during the third year and the cardiovascular nursing intervention was developed to determine the short (3 months) and intermediate-term (6 months) effects in the outcome variables. A randomly selected sample of 60 women from the same cohort was randomly assigned to the developed intervention group (n=30 in each group) and to a delayed-intervention control group.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients

The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of a respirator for the duration of the study as judged by the Investigator.
3. QMG score ≥12 at Screening and Baseline.

Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing.
2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
3. Thymectomy performed \< 12 months prior to screening.
4. Total IgG level \<6 g/L (at screening).
5. Absolute neutrophil count \<1500 cells/mm3(at screening).

Other, more specific exclusion criteria are defined in the protocol
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. In this study we investigate if the consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during nocturnal SWS.


Eligibility Criteria:
Inclusion Criteria:

* healthy Subjects
* unobtrusive, neuropsychological screening
* age: 18-35 years
* right handed

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* contraindications to MRI
Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 months
* Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
* Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion Criteria:

• Received any prior H1N1 vaccination