cyrilzakka/clinical-trials huggingface dataset:
Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure

The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.

Recurrent implantation failure (RIF), defined as failure of conception following three or more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality embryos, is a major cause of distress amongst infertile couples. While factors underlying implantation failure are many, most cases remain unexplained. In order to improve pregnancy outcomes and delivery rates in women with unexplained RIF, various investigational treatments have been proposed.

The investigators propose a prospective controlled randomized comparative study to evaluate the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200 patients will be recruited and randomized between two groups. The study group will receive Bemiparin plus standard care; while the control group will receive only standard care. Treatment will start on the day following embryo transfer and will be continued until 12 weeks gestation in the event of pregnancy.

The primary objective is to determine the effect of Bemiparin on implantation rate in women with unexplained recurrent implantation failure.

Eligibility Criteria:
Inclusion Criteria:

* History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer.
* Normal uterine cavity (as assessed by hysteroscopy or HSG).
* Normal hormonal investigation: TSH, PRL, FBS.
* Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S, Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.
* Normal semen analysis and mild/moderate male factor (Total motile sperm count \> 5 million/ml and/or normal WHO morphology \>20%.
* Patient provides written informed consent.

Exclusion Criteria:

* Evidence of low ovarian reserve by at least one of the following: AMH ≤ 1,5 ng/mL and/or basal CD 3 FSH ≥ 10 mIU/mL and/or basal CD 3 Estradiol ≥ 60 ng/mL and/or previous egg collection yield ≤ 3 oocytes.
* Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition...).
* Severe male factor infertility (Total motile sperm count \< 5 million/ml and/or normal WHO morphology \<20%).
* Hypersensitivity to Heparin or its derivatives.
* Acquired thrombophilia.
* Active hemorrhage or increased risk of bleeding due to impairment of homeostasis.
* Severe impairment of liver or pancreatic function.
* Severe renal insufficiency (Creatinine Clearance \< 30 ml/min).
* Injuries to or operations on the central nervous system, eyes and ears within the last 2 months.
* Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
* Acute bacterial endocarditis and endocarditis lenta.
* Any organic lesion with high risk of bleeding (e.g.: active peptic ulcer, hemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).
Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
* at least 1 month post-stroke
* willingness to participate the project
* minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test)
* passive Range of Motion (ROM) of the shoulder and elbow of more than 90°

Exclusion Criteria:

* epilepsy
* severe spasticity at upper limb (\>= 3 Ashworth scale)
* implanted electronic device
* respiratory insufficiency
* pregnancy
* peripheral neuropathies
* cutaneous ulcers at the stimulation zone
* other use of FES on the upper limb
Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.

This is a Phase IV, randomized, open-label, 2-arm, multicenter study evaluating the efficacy and safety of olaparib in Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have BRCA1/2 mutations. Approximately 42 subjects will be randomized in a 2:1 ratio to olaparib or to investigator's choice of NHA (enzalutamide or abiraterone acetate).

Eligibility Criteria:
Inclusion criteria：

1. Histologically confirmed diagnosis of prostate cancer.
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
6. Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
7. Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

Exclusion criteria：

1. Any previous treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor, including olaparib.
2. Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization.
3. History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
4. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.

This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to 14-unit NobelProcera® Zirconia Implant Bridge. This data collection will be conducted in up to 11 centers (see Appendix I) and will include between 150 to 200 subjects.

The aim of this retrospective multicenter data collection is to evaluate the safety, performance, and clinical benefits of NobelProcera® Zirconia Implant Bridges (4 to 14 units) in daily dental practice.


Eligibility Criteria:
Inclusion Criteria:

* Subject was at least 18 years old at the time of treatment,
* Subjects treated with at least one NobelProcera® Zirconia Implant Bridge (4- to 14-unit supported by 2 to 10 implants).

Exclusion Criteria:

* none
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.


Eligibility Criteria:
Inclusion Criteria:

Patients who present with intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating instability of the responsible segment of the lumbar spine, have severe symptoms that affect daily life and work, and have poor conservative treatment results. Therefore, RPE-P/TLIF single segment or double segment surgical treatment is recommended.

Exclusion Criteria:

(1) Simple lumbar spinal stenosis without responsible segment instability; (2) Long segment (3 or more) spinal stenosis with lumbar instability; (3) Patients with major internal medicine underlying diseases who cannot tolerate surgery; (4) Individuals with comorbid mental disorders or Alzheimer's disease who are unable to cooperate with relevant scale filling and subsequent follow-up; (5) Age\<18 years old.
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.

Postoperative pulmonary complications (PPCs) are the principal cause of morbidity, mortality and prolonged hospitalizations in surgical patients, which results in a 50% increase in healthcare costs compared to postoperative cardiac complications. This is especially evident following cardiovascular surgery. One of the most common PPCs is atelectasis, resulting in dyspnea, tachypnea and hypoxemia.

Postoperative atelectasis is a predictable consequence of anesthesia, surgical trauma, and pain associated with breathing. Methods aimed at increasing lung volume and treating atelectasis, commonly known as postoperative physiotherapy, play an important role in preventing PPCs. These methods include cough and deep breathing, continuous positive airway pressure (CPAP), postural drainage, incentive spirometry and positive end expiratory pressure (PEEP).

Incentive spirometry has served as a convenient approach for the postoperative patient to sustain maximal inflations and encourage deep breathing. Although incentive spirometry is used commonly by post-operative patients, evidence fails to support its benefit.

PEEP is a well-known pulmonary physiologic principle. There are on average 600 million alveoli in the lung. Each alveolus has surfactant to resist the natural propensity for these small air sacs to collapse during exhalation. Despite this surfactant, some alveoli will collapse and not be available for gas exchange. This atelectasis results in a ventilation/perfusion mismatch where alveolar units are perfused but not adequately ventilated. This is referred to as shunting and results in hypoxemia (decreased PaO2). PEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one of the safest ways to increase PaO2 and is used on almost all modern ventilator settings.

The purpose of this study is to compare a novel breathing device, called the GO2 Mouthpiece, which uses the concept of PEEP, to the incentive spirometer in postoperative patients.

Eligibility Criteria:
Inclusion Criteria

1. Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery
2. Able to provide written informed consent
3. Maintenance of an arterial line postoperatively

Exclusion Criteria

1. Active smoking, within three months of surgery
2. Forced expiratory volume in one second (FEV1) \<75% predicted
3. Relative risk to develop pulmonary barotrauma as evident by history of pneumothorax or emphysema
4. Unable or unwilling to provide informed consent, cognitive impairment
Adherence to Computer-assisted Maxillofacial Reconstructions

The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

computer-aided design

Eligibility Criteria:
Inclusion Criteria:

1. Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
2. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.

Exclusion Criteria:

1. Patients undergoing computer-assisted implant surgery were excluded.
2. Patients undergoing computer-assisted orthognathic surgery were excluded.
Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease

Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men \< 55 years old, women \< 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between early-onset myocardial infarction and atherosclerosis.

Premature coronary heart disease is defined as the first onset of male \< 55 years old, female \< 65 years old, confirmed by clinical examination. A number of studies have found that smokers have a significantly increased risk of acute myocardial infarction, and suggest that continued smoking is still an independent predictor of mace. These findings suggest that smoking is significantly associated with early-onset coronary heart disease. A number of studies have found that smoking can increase peripheral arterial stiffness. At present, there is no study on peripheral arterial stiffness in patients with early-onset myocardial infarction, so we suspect that peripheral arterial stiffness in patients with early-onset myocardial infarction is significantly increased

Eligibility Criteria:
Inclusion Criteria:

* The onset of coronary heart disease (including acute coronary syndrome and stable angina pectoris) was less than 55 years old in men and 65 years in women

Exclusion Criteria:

* Non coronary heart disease leading to chest pain (myocarditis, pericarditis, pulmonary embolism, aortic dissection, unstable angina pectoris) definite infection tumor liver and kidney insufficiency autoimmune disease acromegaly hyperthyroidism and subclinical hyperthyroidism secondary hypertension, etc.
FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≤ 15 kg.
* Elective cardiac surgery with cardiopulmonary bypass.
* Coagulopathic bleeding after cardiopulmonary bypass.
* Availability and willingness of the parent/legal guardian to provide informed consent.

Exclusion Criteria:

* Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
* Patient or family history of coagulopathy and/or thromboses.
* Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs

This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.

Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, this study will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. This study will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, the study will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.

Eligibility Criteria:
Inclusion Criteria:

* Minnesota physician or physician assistant
* Controlled substance prescriber not following state requirements to maintain an active PDMP account, or opioid prescriber not searching the PDMP or infrequently searching the PDMP

Exclusion Criteria:

* No e-mail address available
Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia

The study is aimed at confronting a surgical pleth index based protocol for intraoperative analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are expected.


Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<80 years
* American society of anesthesiology (ASA) physical status I -II
* 6 hrs fasting

Exclusion Criteria:

* Arrhythmia or Pacemaker
* Central or peripheral nervous system or muscular disease
* Drugs active on autonomous nervous system (eg clonidine)
* Obesity (BMI \>35)
* Chronic Pain
* Addictions or central nervous acting drugs use
* Hypertension (if not treated)
* Connective tissue disease
* Pregnancy
* Allergy or hypersensitivity to study drugs
* QT prolongation
* Absence of inclusion criteria
Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome

Evaluate the efficacy of two regimens of management in relieving chronic refractory pain in patients with upper limb complex regional pain syndrome after orthopedic trauma

Ideal therapy for Complex Regional Pain Syndrome is multimodal with the use of physical therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures. Within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory drugs (NSAIDs), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and N-methyl-D-aspartate (NMDA) receptor antagonists (i.e., Ketamine).

In complex Regional Pain Syndrome treatment, stellate ganglion block (SGB) is a well-established method of nerve blockade of the sympathetic ganglia in the lower cervical and upper thoracic region.

Epidural block have differential block as sensory, motor, and sympathetic. Nerve functions are blunt at different rates and to different degrees. Sensory block occurs with a lower concentration of Local anathesia and develops faster than motor block with coexisting sympathectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged more than 21 years old of both sexes with American Society of Anesthesiologists I and II
2. Upper limb trauma patients with pain disproportionate to the degree of tissue injury and persists beyond the normal expected time for tissue healing
3. Patients diagnosed as (Complex Regional Pain Syndrome ) based on Budapest criteria There should be at least one symptom or sign in three of the four previous categories that can not be explained by other diagnosis.
4. The average daily pain intensity required on Numerical Rating Scale is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy Non-steroidal anti-inflammatory drugs, Antiepileptic drugs(AEDs), antidepressants), as well as physical therapy and psychiatric care.

Exclusion Criteria:

* Patient refusal
* Patients with unstable psychological or psychiatric conditions, including: untreated bipolar disorder, post-traumatic stress disorder, major depression, severe personality disorder and psychotic illness
* Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies.
* Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs
* Patients with previous severe reactions, contraindication or allergy to ketamine
* Patients with hepatic or renal impairment
* Active infection at the injection site
* Known allergies to medications
* Previous neck surgeries
* Raynaud's disease or Raynaud's phenomena
* Coagulopathy
Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

This study is based on human anatomical data and uses computer-aided engineering (CAE) software such as biomedical image processing software, reverse engineering software, CAD software, and finite element analysis software to create a three-dimensional bracing model. With the help of 3D printing technology, we have developed personalized brace, completed the personalized rapid design and optimization of the three series of support equipment products such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.

The traditional brace mainly includes small splints or gypsums. The manufacturing process is rough, and the flexibility is poor. In recent years, with the development of orthopedic surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress has been made in R\&D, production, and assembly of orthoses. In developed countries, orthoses is not only widely used after orthopedic surgery and the department of rehabilitation, but it has become the main auxiliary device for sports trauma surgery, immobilization, treatment, and rehabilitation training. Leading bracing company such as DJO has developed multi-brand correction devices such as Aircast®, Chattanooga, CMF, COMPEX®, DonJoy®, Empi® and ProCare®. However, these braces are not designed and manufactured based on patients. Individually designed products for anatomical structures still have many problems in clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.

Exclusion Criteria:

* Severe peripheral ligament injury of should, knee and ankle.