cyrilzakka/clinical-trials huggingface dataset:
Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall response rate after 4 cycles of velcade and dexamethasone administration.


Eligibility Criteria:
Inclusion Criteria:

* Have received at least 1 and no more than 3 prior lines of therapy for multiple myeloma
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* The toxicities resulting from previous therapy must be resolved or stabilized to less than or equal (\<=)Grade 1 prior to drug administration
* A woman of childbearing potential must have a negative highly sensitive serum (human chorionic gonadotropin \[hCG\]) or urine pregnancy tests at screening within 14 days prior to Cycle 1 Day 1
* Have documented evidence of progressive disease/disease progression based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria on or after their last regimen

Exclusion Criteria:

* Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day (mg/day) for a maximum of 4 days) before treatment.
* Received autologous stem cell transplant (ASCT) within 12 weeks before the date of randomization, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
* Plans to undergo a stem cell transplant prior to progression of disease on this study, that is, these participants should not be enrolled in order to reduce disease burden prior to transplant
* Is known to be infected with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
* Had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities
Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus

The aim of this study is to explore the diagnostic efficacy of oral glucose tolerance test in early pregnancy and establish the prediction model for gestational diabetes mellitus, so as to provide the optimal screening of gestational diabetes mellitus in the first trimester. The treatment started when the pregnancy was confirmed by transvaginal ultrasound (around 6 weeks of gestation) and continued until 42 days postpartum. The study is a single center, prospective cohort study. A total of 781 participants within 14 weeks of gestation were recruited.


Eligibility Criteria:
Inclusion Criteria:

* 1. Intrauterine pregnancy within 7-14 weeks of gestation
* 2. 20-45 years of age
* 3. Singleton pregnancy
* 4. Giving informed consent and willing to participate in this study
* 5. Planning to give birth in Women's Hospital School of Medicine Zhejiang University

Exclusion Criteria:

* 1. Pre-existing diabetes
* 2. Taking medications that may affect blood glucose levels within one month
* 3. Participating in other intervention studies
* 4. Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation
Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

It is well known that lowering average blood glucose decreases the risk of diabetic complications involving the small vessels, such as those found in the eyes, nerves and kidney. It is less clear however, if controlling fluctuations in blood glucose will further help to prevent such complications.

The purpose of this study is to examine the relationship between extreme fluctuations in glucose and damage to the blood vessel lining.

Studies have shown that glycemic variability is associated with oxidative stress which in turn has been correlated with endothelial damage. Further, endothelial damage has been identified as a critical event lending way to the vascular complications seen in many disease states.

The specific aim of this study is to investigate the relationship between short-term glycemic variability and biomarkers of endothelial dysfunction while analyzing the influence of different variables and adjusting for covariates.

Data obtained from a continuous glucose monitoring system(CGMS), a device that continuously records interstitial glucose for a 72 hour period, is used to calculate glycemic variability. Serology for the determination of endothelial dysfunction biomarkers is obtained on day three.

Pearson and Spearman Rank Order correlations are utilized to determine whether there are any significant correlations between measures of glycemic variability and biomarker levels of endothelial dysfunction. Multiple regression analysis would also determine if glycemic variability predicts elevated biomarker levels even after controlling for other variables.

Provided the high prevalence of diabetic complications and their staggering socioeconomic costs, it is important to elucidate the relationship between glycemic variability and endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin \<8.0%

Exclusion Criteria:

* Age \<18 or \>65
* BMI \>35
* Pregnant
* Baseline glycosylated hemoglobin \<6.0% or \>8.0%
* Winthrop University Hospital Employee or Staff member
* Vulnerable subject
* Uncontrolled hypertension(defined as systolic blood pressure \>130 or diastolic blood pressure \>80mmHg)
* Uncontrolled dyslipidemia (defined as LDL \>130mg/dL; HDL \<30mg/dL or triglycerides \>199mg/dL)
* Current smoker or significant smoke exposure(defined as greater than 2 hours of exposure to second-hand smoke within the preceding 48hrs)
* Sympathomimetic use within the past week
* History of cardiovascular disease
* History of paroxysmal nocturnal hemoglobinuria
* History of thrombotic thrombocytopenic purpura
* History of stage II-V Chronic Kidney Disease
Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy

Adeno-tonsillectomy is one of the most common surgeries in children. The most common complication associated is postoperative pain. If not well controlled, especially in preschool children, it can lead to a longer recovery period, delayed discharge, and nutritional deficiencies resulting in dehydration. These factors will increase hospitalization period and the need for intravenous fluids.

For this purpose, a large number of studies has been designed to evaluate the analgesic effects of various drugs during the perioperative period. Opioids are associated with sedation and respiratory depression, NSAIDs increase the risk of reoperation for bleeding while local anesthetics may cause vasoconstriction of the operation site.

For several years, N-methyl-D-aspartate (NMDA) receptors antagonists, such as ketamine and magnesium, have been used successfully to decrease postoperative pain and analgesic requirements in adult patients undergoing a number of different procedures. Ketamine reduces the needed analgesia after tonsillectomy. Most studies have shown that ketamine administration has no side effects such as hemodynamic, respiratory complications and airway problems.

Magnesium is a physiological antagonist of the NMDA receptor ion channel that plays a key role in central sensitization. Many studies have investigated the effect of magnesium sulphate on postoperative pain and opioid consumption. However, results of those studies were variable. Whereas most studies describe the reduction of postoperative analgesic requirements after magnesium sulfate, a few studies show insignificant beneficial effects.

A previous study evaluated the effect of low dose ketamine (0.15 mg/kg) and magnesium sulfate (30 mg/kg) on post tonsillectomy pain in children, which did not demonstrate a decrease in pain or analgesic consumption in children undergoing tonsillectomy. In this study, the investigators will increase the dose of ketamine to (0.5 mg/kg) and magnesium sulfate to (40 mg/kg) to evaluate their effect on postoperative pain in pediatric patients undergoing adeno-tonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders.
2. American society of anesthesiologists (ASA) physical status class I and ll.
3. Patients undergoing adeno-tonsillectomy.

Exclusion Criteria:

1. Inability to provide an informed consent.
2. Patients with suspected difficult airway.
3. History of allergy to ketamine or magnesium.
4. Metabolic and endocrine disorders.
5. Growth developmental, and motor-mental retardation.
Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome

Combined letrozole with chromium versus letrozole only in induction of ovulation in polycystic ovary syndrome

Randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* female patients aged from 18 to 35 years Anovulatory cycles Pcos

Exclusion Criteria:

* female patients aged more than 35years Male factor of infertility Other factors of infertility than pcos
Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia

The disability inflected by dystonia encouraged the development of many neurosurgical procedures.

This is a prospective study included 120 patients suffering from intractable secondary dystonia.

They were subjected to different neurosurgical treatments and were assessed through the follow up period

Background:

Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.

The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.

Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.

Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.

Eligibility Criteria:
Inclusion Criteria:

* secondary dystonia of previous etiologies

Exclusion Criteria:

* patients who are not candidate for anaesthesia
Biomechanics and Clinical Outcomes in Responders and Non-Responders

Knee osteoarthritis is a degenerative joint disease that affects many older adults. However, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required.

The included participants will be provided with informed consent and an explanation of the study procedure before enrolling in data collection. The data collection will be arranged in the same order. Practice trials will be provided before the start of data collection. The data collection will consist of standardized questionnaires, assessments, and tests commonly used in clinics.

During data collection, markerless motion capture systems will be placed around the area of interest. The markerless system does not require markers to be attached to the participant's body.

The data collection will include:

1. Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, and the Kellgren-Lawrence score.
2. Patient-reported questionnaires such as the numeric pain rating scale, knee injury and osteoarthritis outcome score, Western Ontario and McMaster Universities Osteoarthritis, and Depression, Anxiety, and Stress Scale - 21 Items.
3. Clinical assessments such as the Varus-valgus laxity test, Foot posture index, Range of motion, Muscle flexibility, and Muscle strength.
4. Functional tests such as the Timed up and go test, Five times sit-to-stand test, Four-meter walk test, and Bipedal quiet stance test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee osteoarthritis based on American College of Rheumatology
* Pain intensity of ≥ 4 out of 10 at the pre-treatment day
* Ability to walk for at least six meters without an assistive device

Exclusion Criteria:

* History of previous lower limb surgery, such as total hip replacement
* History of neurological disorder, such as stroke
* History of vestibular disease, such as Meniere's disease
Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery

The main objective of the study is to demonstrate the efficacy of Dexmedetomidine on the prolongation of analgesia obtained by interscalenic bloc of the brachial plexus and intravenous injection of Dexamethasone (efficacy objective).

This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of Dexmedetomidine over the absence of Dexmedetomidine, in adjuvantation of a loco regional anesthesia (interscalenic bloc of the brachial plexus + intravenous injection of Dexamethasone), on the prolongation of the analgesia, following a surgery of the rotator cuff of the shoulder under arthroscopy.

Patients will be randomized into 2 groups according to the treatment received:

* Dexmedetomidine;
* Nothing (control arm). The investigator (anesthesiologist) who will perform the randomization will not be blinded to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patient undergoing arthroscopic shoulder surgery to repair the rotator cuff tendons;
* Patient capable of understanding the information related to the study, of reading the information leaflet and agreeing to sign the consent form.

Exclusion Criteria:

* Patient on oral morphines before surgery;
* Contraindication to performing a general anesthesia associated with a shoulder loco regional anesthesia in a single injection;
* Contraindication to take oral morphines;
* Any non-arthroscopic repair (intraoperative conversion to "open sky" technique);
* Any other loco regional anesthesia than an interscalenic block (change of intraoperative strategy);
* Pregnant or lactating woman;
* Intolerance or allergy or contraindication to one of the treatments under study;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial.
Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome

To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in relieving chronic refractory pain in patients with complex regional pain syndrome

Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that initially became commercially available for human use in 1970 as a rapid-acting intravenous (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.

Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and abuse potential. It is favorable due to its short half-life and lack of clinically significant respiratory depression. In addition to its anesthetic effects, ketamine has analgesic, anti-inflammatory, and antidepressant activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 21 years old of both sexes with American Standards Association I ,II.
* Patients diagnosed as ( CRPS) based on Budapest criteria
* The average daily pain intensity required on (NRS) is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy as non steroidal anti- inflammatory drugs (NSAIDs), antiepileptic (AEDs), antidepressants), as well as physical therapy and psychiatric care

Exclusion Criteria:

* patients 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 within 3 months of enrollment.
* 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 cardiovascular disease (hypertension, arrhythmia), hepatic, renal or other organ impairment.
Patient Education in Ankylosing Spondylitis

This study was carried out to investigate the effect of a nurse-led disease management education program in AS on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. A total of 122 patients diagnosed with AS according to the modified New York criteria were included in the study. The intervention group received nurse-led individualized disease management education. In the control group, no interventions were performed other than routine clinical procedures.

This study was carried out to investigate the effect of a nurse-led disease management education program in AS on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. A total of 122 patients diagnosed with AS according to the modified New York criteria were included in the study. The intervention group received nurse-led individualized disease management education. After the education, the group was contacted by telephone six times for 12 weeks to monitor the results. Patient education was provided through booklets and videos. In the control group, no interventions were performed other than routine clinical procedures.Patients were assessed using the same scales at baseline and end of the week 12.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years
* Have a clinical diagnosis AS according to the modified New York criteria
* Receiving TNF-α inhibitor treatment.

Exclusion Criteria:

* Communication difficulties
* Illiterates
Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study

This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.

The purpose of the study is to measure the rate of expulsion of the copper intrauterine device (ParaGard®) when placed immediately after childbirth. Many women in the United States have unintended pregnancies. Long-acting reversible birth control methods, like the copper intrauterine device (IUD), help prevent unintended pregnancy. This is because, once in place, the copper IUD provides excellent pregnancy prevention, and women using it do not have to do anything extra to make sure it works (like taking a birth control pill every day, for example). The copper IUD is safe and well liked among women who use it. Around the world, women have been getting their IUD fitted right after childbirth for the past 20 years, and this practice has been shown to be safe. This service has been offered at HUP since early 2014. When the IUD is placed after birth, there is a chance that it could fall out, as the uterus shrinks back to its pre-pregnancy size. Women who get their IUD fitted right after childbirth will be observed, and describe the rate of IUD expulsion at 6 months postpartum. Factors associated with IUD expulsion will be noted. Adult pregnant women delivering at the Hospital of the University of Pennsylvania, desiring an immediate IUD, and willing to follow up 6 months after birth, will be eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman age 18 years or more
* Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
* Anticipating a delivery at the Hospital of the University of Pennsylvania
* Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
* Able and willing to give consent in English
* Willing to follow up 6 months after delivery

Exclusion Criteria:

* Allergy or contraindication to TCu380A
* Known cervical cancer or carcinoma in situ
* History of undiagnosed abnormal vaginal bleeding prior to pregnancy
* Unwilling to follow up in the six months following delivery will be excluded

Additional exclusion criteria apply after delivery:

* Preterm delivery (33 weeks 6 days gestation or less at birth)
* Clinical diagnosis of chorioamnionitis or treatment for presumed chorioamnionitis
* No longer desiring immediate postplacental TCu380A placement
* Subjects aged less than 18 years
* Men are excluded by the nature of this women's health research.