cyrilzakka/clinical-trials huggingface dataset:
Effect of Oxycodone on Anxiety State in Painless Abortion

In this study, 300 patients who underwent painless abortion in Ruijin Hospital and sub-central hospitals were selected through a multi-center randomized controlled study, and 300 patients who underwent painless abortion in Ruijin Hospital and each sub-center hospital were divided into intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O) by stratified group randomization method 1:1. The difference between the postoperative anxiety scores and depression scores of the two groups was observed, and the postoperative anxiety, depression and numerical pain scores were recorded. Finally, the relevant data were statistically analyzed and conclusions were drawn.

This study is a multicenter, randomized controlled clinical study. A total of 300 patients who underwent elective painless abortion surgery in Ruijin Hospital and other sub-central hospitals were enrolled, and they were randomly divided into 1:1 patients who received intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O). The scores of anxiety, depression and postoperative numerical rating scale (NRS) before and after surgery were observed, and the levels of serum stress response factors and inflammatory cytokines were monitored. The effects of oxycodone on anxiety, depression and postoperative acute pain in patients with painless abortion were investigated.

1. Main observation indicators:

   The difference between the post-operative anxiety score and the preoperative anxiety score
2. Secondary Observational Indicators:

   * Post-operative anxiety score
   * The difference between the post-operative depression score and the preoperative depression score
   * Post-operative depression score
   * Pain assessment after surgical recovery (NRS)
   * Laboratory tests
   * Patient and family satisfaction with postoperative analgesic treatment

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old
* Gestational age 6-12 weeks
* American Society of Anesthesiologists （ASA） Grading I-II
* Fluent communicator and able to complete self-rating scales on her own
* Voluntarily participate and sign the informed consent form

Exclusion Criteria:

* Patients who are allergic to anesthetic drugs such as propofol, oxycodone, fentanyl, etc., or who have had other anesthetic adverse events
* Patients with anxiety or depression
* Presence of organic mental disorders, mental retardation
* Severe acute and chronic infection, severe heart, liver and kidney insufficiency
* Patients with complications or bleeding \> 50ml during surgery
Bellomic PCA in Laparoscopic Gynecologic Surgery

In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiology physical status 1 or 2
* Patients scheduled for gynecological laparoscopic surgery under general anesthesia
* Patients who applied for the use of IV-PCA after surgery

Exclusion Criteria:

* Patients with side effects of opioids
* Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
* Patients with alcohol or drug dependence
* Patients with peptic ulcers, patients with gastrointestinal bleeding
* Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
* Symptoms of bronchial asthma or bronchospasm
* Patients with severe respiratory depression
* Moderate to severe renal impairment
* Patients with reduced blood volume or dehydration
* polyps in the nose
* angioedema
* Patients with or a history of the convulsive disease
* Patients for whom the use of neuromuscular blocking agents is contraindicated
Strength Training Protocol in Fibromyalgia Women

Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.

The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.

In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.

Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Women previously diagnosed with fibromyalgia and healthy women aged 18-75 years.
* Not be undertaking any physical activity or exercise programme for at least three months prior to the start of the protocol.

Exclusion Criteria:

* Participants in the study may not present any other illness and/or injury at the time of the assessments that would prevent them from carrying out the activity. In the same way, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.
IVIG Vs SCIG in CIDP

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing strategies are suggested, but these recommendations are based on expert opinion rather than high quality evidence. The adoption of a specific strategy is highly variable depending on the clinician and/or institutional setting. Recently, payors have also adopted strategies to reduce IgG therapy costs of by capping doses. These recommendations are often based on the presumption that IgG distribution is limited to the vascular space. While this assertion is logical, it does not account for changes adipose tissue may confer on target sites, nor does it account for the potential for adipose tissue to function serve as a metabolic sink or a source of inflammatory mediators. The later would be especially important in patients receiving SCIG. Several observational studies have evaluated IgG dosing in obese patients and have been the source of support for dosing strategies. Many of these studies were not representative of specific populations, contained a wide variety of patients with different IgG indications, and had inadequate serum sampling. More recently, the phase III randomized controlled PATH trial did not find a correlation with serum IgG concentrations and clinical endpoints. However, it is important to note that the study was not designed to evaluate pharmacokinetic and pharmacodynamic endpoints. There is also considerable interpatient variation in response; therefore, identification of patient characteristics that predict response or IgG change from baseline will be a useful tool to improve patient responses. Our study will evaluate the influence of body composition and other patient characteristics may have on IgG exposure when given intravenously or subcutaneously.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
* 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.

Exclusion Criteria:

* Patients receiving IVIG for indications other than CIDP will be excluded.
* Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl \< 50 mL/min) will be excluded
* Active malignancies
* Diabetes
* Myasthenia gravis
* Immunodeficiency
* Autoimmune disease
Ultrasound and X-ray in Detecting Articular Cartilage Calcification

Prospective study with an echography of the 2 knees and radiography of the 2 knees (front and profile) for each patient. If found calcification on ultrasound further examination with ultrasound wrists, hips and shoulders.

Osteo-articular echography is currently recognized as an important development among rheumatologists.

Chondrocalcinosis, which can promote joint inflammation and cartilage degeneration, is highly prevalent in elderly subjects.

Osteo-articular echography is currently reconized as an important development among rheumatologists and can efficiently use to detect Chondrocalcinosis.

The aim of this study is to find a correlation between radiography and echography in detecting CPPD crystal deposition, on a sample of patients and more important with a new generation of ultrasound with a probe superficial performance.

166 patients will be enrolled in this trial and an echography and a radiography of the 2 knees (front and profile) will be done for each patient.

Ih the echography show a calcification, further exams with wrists, hips shoulders echographies will be conducted.

In case of liquid epanchement, analysis of the liquid will be carried in order to eliminate the differential diagnostic including septic arthritis

Eligibility Criteria:
Inclusion Criteria:

* patient\> 70 years
* articular pathology of the knee
* consent signed

Exclusion Criteria:

* Not covered by social security
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL.

The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

Key Inclusion Criteria:

* Aged \>= 18 years old at the time of informed consent.
* Histologically confirmed follicular Grade 1-3a NHL.
* Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
* Bidimensionally measurable disease with at least 1 lesion \>= 2.0 cm in a single dimension.
* Acceptable hematologic, hepatic, and renal function parameters.
* Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs.

Key Exclusion Criteria:

* Follicular lymphoma Grade 3b.
* Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months).
* Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C).
* Prior lymphoma vaccine therapy within 12 months prior to Study Day 1.
* Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1.
* Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1.
* Prior allogeneic transplant.
* Transfusion-dependent subjects.
* Another primary malignancy requiring active treatment (except hormonal therapy).
* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain

Identification of the effects of spinal stabilization exercises and manual therapy methods on pain, function and quality of life in individuals with low back pain.

113 patients participating in the study were divided into two groups. The patients in the physiotherapy group were instructed to perform special spinal stabilization exercises, while the patients in the manual therapy group were instructed to perform soft tissue mobilizations, muscle-energy techniques, joint mobilizations and/or manipulation methods depending on the nature of their lower back pain problems. Both groups were offered stabilization, strengthening, stretching, balance and exercise trainings as well as recommendations as to the daily life activities in line with the requirements of each individual. The severity of the pain suffered by the individuals was evaluated through a Visual Analog Scale. Oswestry Disability Index and Short Form-36 (SF-36) Scale were made respectively with respect to the functional condition and life quality. Assessments were repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic low back pain
* must have pain at least 3 or more according to Visual analog scale

Exclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis
* Clinical diagnosis of Alzheimer
* Clinical diagnosis of Peripheral Neuropathy
* Clinical diagnosis of Diabetes Mellitus
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.

Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.

Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

1. Approved for cardiac transplantation
2. Listed with UNOS on the Status 1 list
3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

1. Contraindication to the administration of warfarin or anti-platelet agents
2. Primary coagulopathy or platelet disorder
3. Acute myocardial infarction within 48 hours prior to enrollment
4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation
5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
Safety of Apollo Micro Catheter in Pediatric Patients

This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).

-Why is this study being done?

The purpose of this study is to evaluate the safety of the Apollo Embolization Delivery Micro Catheter device (device that looks like a long thin hallow tube) when used in Pediatric patients with vascular malformations.

The Apollo Onyx Delivery Micro Catheter device is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Apollo Onyx™ Delivery Micro Catheter device is not approved for use in the U.S, although it is widely used and approved for use in Europe (CE0297).

This clinical study is sponsored by Dr. Alejandro Berenstein of St.Luke's-Roosevelt Hospital, New York who is also the principal Investigator of the study. Total duration of study is up to 30 months with approximately an 18 months enrollment period. Patients follow up period is up to 12 months upon enrollment.

Eligibility Criteria:
Inclusion Criteria:

* The subject or subject's legally authorized representative has signed and dated an informed Consent Form.
* Subject's age is ≤ 21 years.
* The subject has a confirmed diagnosis of brain arteriovenous malformation in the cerebral cortex, cerebellum or dura mater that is indicated for endovascular embolization with Onyx™ LES or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Systems and where the use of Apollo Embolization Delivery Micro Catheter may or may not be indicated for surgical resection.
* The subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
* The subject has a life expectancy of at least 1 year with the exception of new born babies with Vein of Galen malformation with cardiopulmonary failure where no other treatment option remains.
* The subject agrees to and is capable of completing all study required procedures

Exclusion Criteria:

* Female who is pregnant or lactating.
* Current participation in another investigational drug or device study.
* Subject has a brain tumor or other malignancy
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

The objectives of the study are:

1. Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein.
2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
3. Analysis of patient's blood samples for the detection of activated kinases.


Eligibility Criteria:
Inclusion Criteria:

Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories:

1. previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha.
2. not previously treated but with documented Fip1L1-PDGFRA fusion protein

Exclusion Criteria:

* Other diseases associated with hypereosinophilia
* Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
* ECOG performance status \>3

Other protocol-defined exclusion criteria may apply.
A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer

The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..

Eligibility Criteria:
Inclusion Criteria:

1. Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
2. Measureable disease per response evaluation criteria (RECIST) v1.1
3. Prior bevacizumab
4. Age \> or = 21 years
5. Adequate organ and marrow function
6. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
2. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
3. Subjects with brain metastases
4. Subjects with leptomeningial disease or neoplasms in the last 5 years
5. Blood pressure \>140/80
6. Significant intercurrent illness that will limit the patient's ability to participate in the study
7. Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
9. Pregnant or nursing women
10. New York Heart Association Classification II, III, or IV
11. Inability to comply with study and follow up procedure