cyrilzakka/clinical-trials huggingface dataset:
Elective Induction vs Spontaneous Labour in Patients With Heart Disease

Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were randomised into elective induction and spontaneous labour groups only after bishop score was equal to or more than 6.It was concluded that induction of labour with oxytocin is a relatively safe procedure in women with low risk heart disease with NYHA class I and II. It resulted in a similar caesarean delivery rate and was not associated with more maternal and neonatal complications.

Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml normal saline was prepared and given through infusion pump at initial rate of 3mU/min. Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were established.

Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given intravenously for pain relief.

Eligibility Criteria:
Inclusion Criteria:

* NYHA class I-II
* cephalic presentation
* singleton gestation

Exclusion Criteria:

* previous cesarean section,
* Primary pulmonary hypertension,
* Eisenmenger syndrome,
* Marfan syndrome,
* Left heart obstruction,
* Prior cardiac event or arrhythmia,
* Malformed fetus,
* Severe anemia (\<7g/dl),
* Intrauterine fetal death,
* other obstetrical indications for induction of labour
* patients on anticoagulation.
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.

Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.

Eligibility Criteria:
Inclusion Criteria:

* Performance status (WHO) 0-2
* Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
* HER-2 overexpression 2+ or 3+ using IHC or FISH +
* Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
* No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
* More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
* No prior first line chemotherapy for metastatic disease
* Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
* Paraffin block from the primary tumor available in the research lab
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
* Adequate cardiac function (LVEF \> 50%)
* Informed consent

Exclusion Criteria:

* Pregnant or nursing
* Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
* Positive pregnancy test
* Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria
* Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
* History of allergic reaction attributed to docetaxel
* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.

Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo elective LC.
* Adults (males and/or females) between the ages of 18-70 years old.

Exclusion Criteria:

* Chronic pain other than cholelithiasis.
* Patients who received analgesics or sedatives 24 h before scheduled surgery.
* Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \<30ml/min)
* Previous allergic response to granisetron.
* Pregnancy and lactation
* Patients with communication problems, cognitive dysfunction, or psychological disorders
* Daily corticosteroid use
Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant

Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age;
* The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on clinical examination and X-ray;
* The patient is eligible for surgical treatment of CMC I arthrosis in the opinion of the investigator.
* The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
* The patient is able to understand the aims and objectives of the trial and is willing to consent;
* The patient is willing and able to return for all study-related follow-up procedures;
* If the patient is female, is either using contraception or is postmenopausal, or male partner is using contraception

Exclusion Criteria:

* The patient is suffering from Rheumatoid arthritis in the index hand;
* The patient is suffering from Grade IV osteoarthritis of the CMC joint;
* The patient is suffering post-traumatic arthritis of the CMC joint in the index hand;
* The patient is a pregnant/lactating female (tested as per institutional requirements);
* Active or latent infection, or sepsis;
* Insufficient quantity or quality of bone and/or soft tissue in the index hand;
* Metal or polymer material sensitivity;
* Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;
* Patient with previous thumb surgery in the index hand
* In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to

  * Patients with a diagnosis of concomitant injury that may interfere with healing
  * Patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult
* Patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents
* Comorbidity that reduces life expectancy to less than 36 months
G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

* Use of acetaminophen
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification of the study-assigned blood glucose meter
Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain

To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergo gynecological or orthopedic surgery under epidural anesthesia

Exclusion Criteria:

* A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient.

In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress.

Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.

The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures.

Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery.

To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* elective noncardiac surgery (moderate-high-risk) lasting \> 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)

Exclusion Criteria:

* end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score \>22; predicted forced expiratory volume \< 30%, severe heart failure)
* life expectancy \< 24h
* psychiatric disorders or unability to give independent consent to the study
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.

Patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. Patients older than 55 years will receive the six blocks with attenuated chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients diagnosed with de novo mature B-ALL, Burkitt lymphoma (BL). Under physician's criteria, patients with unclassified B-lymphoma with intermediate characteristics between DLBCL and BL could be included.
* Candidate to intensive treatment.

Exclusion Criteria:

* Other ALL subtype different from mature B-ALL/BL
* Severe complications not due to mature B-ALL/BL (eg, sepsis, pneumonia, shock or hemorrhage) at diagnosis.
* Renal failure not due to mature B-ALL /BL
* Heart or liver failure
* Severe lung disease
* Secondary mature B-ALL/BL
* Hypersensitivity to foreign proteins
* Previous treatment with cytotoxic drugs
* Pregnancy/breastfeeding
* Severe psychiatric disease
* Lack of social or familiar support
Eldercare Technology in a Silver Culture Village

The aim of this project is to create ten smart devices that involve combining an interactive art environment with IC technology, arts and health administration. Investigators invited the elderly residents of Chang Gung Health and Culture Village to participate in the application of these devices, and participants were also requested to complete a technology acceptance model (TAM) questionnaire for these smart devices.

According to statistics in Taiwan, by 2050, one-third population of Taiwan citizens will be over 65 years old. By the definition in World Health Organization, "Active aging" is the process of optimizing opportunities for health, participation and security in order to enhance the quality of life as people age. Active aging aims to extend healthy life expectancy and quality of life for all people as they age.

Chang Gung Health and Culture Village is one of the largest and most experienced aged care and retirement living providers in Taiwan.In this project, for promoting the successful aging of elderly residents, investigators will integrate health management systems and wireless sensor networks, physiological telemetry, learning and exercise behavior in Chang Gung Health and Culture Village. The investigators expect to build a Intelligent Care Facilities space for Elders base on exercise and rehabilitation with ten smart devices that involve combining an interactive art environment with computer science technology, multimedia applications and health administration in three years. Investigators invited the elderly residents to participate in the application of these devices, thereby increasing participants' physical activity and improving the physiological conditions. Participants were also requested to complete a technology acceptance model (TAM) questionnaire for these smart devices.

With respect to old age, long-term care is the human rights. How to provide an excellent eldercare to the elder people is a challenge. "Elder care", "Technology", "Art", "Medicine", a team of interdisciplinary experts is required to achieve this goal. The products of this study will promote an excellent elder care, in the setting of their choice by offering older people the information, services and support needed to make choices which enhance health, well-being and independence. In addition to analyze the acceptance model of intelligent care facilities for elders, the investigators expect the experience can help academic and industrial circles to research and develop care facilities for elders in the future.

Eligibility Criteria:
Inclusion Criteria:

* elderly who lived in the Chang Gung Health and Culture Village

Exclusion Criteria:

* inability to complete questionnaires
Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Eligibility Criteria:
Inclusion Criteria:

* The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
* The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
* The subject must meet defined chemistry criteria as specified in the protocol
* Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
* The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form

Exclusion Criteria:

* The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion.
* The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
* The subject is a lactating or pregnant female.
Evaluation of Education and Equipment in the Prehospital Setting

In a national online based survey the investigators are targeting paramedics for these survey that are involved in prehospital setting. In this study the investigators want to get more information about the current standard or levels of education in prehospital emergency medicine (e.g. airway management) and the incidence of the independently application in daily practice. Furthermore the investigators want to know the current hygiene concepts especially in the actual SARS-CoV-2 Pandemic.

Every participant can answer the survey just once.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants/paramedics

Exclusion Criteria:

* None
Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma

This is a retrospective, single-center, non-randomized, non-controlled study. This study aims to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in lymphoma patients who were treated by autologous stem cell transplantation.

High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is the consolidation treatment for advanced lymphoma patients and approved for treating recurrent and refractory lymphoma by prolonging progression-free survival significantly while also improving quality of life. Evidences to date, have validated that changes of T-lymphocyte subsets after autologous stem cell transplantation associated closely with immunologic reconstitution, and have produced amazing effects in prognosis. Whether T-lymphocyte subsets changes could serve as an effective index for prognosis has been a serious question for lymphoma patients treated by autologous stem cell transplantation. In this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma patients before and after autologous stem cell transplantation, and evaluate the significant effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women≥18 years, \<65 years;
2. Lymphoma patients treated by autologous stem cell transplantation for the first time;
3. ECOG ≤ 2;
4. Ccr ≥ 50 ml/min;
5. ALT, AST and TBIL≤2.5-fold upper normal range;
6. Satisfactory heart and lung function;
7. Women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to practice birth control during the study and one year post study;
8. Good compliance and sighed informed consent voluntarily.

Patients should be conformed to all inclusion criteria above.

Exclusion Criteria:

1. Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;
2. Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
3. Serious complications;
4. LVEF\<55%;
5. Atopy or allergy to biological product derived from colibacillus;
6. Women who are breastfeeding, pregnant or refused to practice contraception;
7. Severe mental or nervous system diseases;
8. Severe abnormalities of heart, lung and central nervous system symptoms;
9. Patients with sickle cell disease, erythronoclastic anemia or other hematological disease which has an impact on medullary hematopoiesis;
10. Enrolled in other study currently or 30 days before screen;
11. Patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

Patients conformed to any of above criteria should be excluded from this study.
Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée

Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Background:

Sudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.

Main objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.

Methodology :

Recruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire

Analysis of the results after the recruitment has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Adult

Exclusion Criteria:

* Patients group : Not have a chronic neuropathy