bioihbjkbjnl/mcl2 huggingface dataset:
Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Effective pain relief after cardiac surgery has assumed importance with the introduction of
      fast track discharge protocols that requires early weaning from mechanical ventilation.
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of
      atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound
      has shown to improve early postoperative pain in various surgical procedures.

      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in
      animal and human models of pain.
    

Detailed description: 
      Effective pain relief after cardiac surgery has assumed importance with the introduction of
      fast track discharge protocols that requires early weaning from mechanical ventilation.
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of
      atelectasis, and prolongs recovery.

      A major cause of pain after cardiac surgery is the median sternotomy particularly on the
      first two postoperative days.

      The most often used analgesics in these patients are parenteral opioids which can lead to
      undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.

      Infiltration of local anesthetics near the surgical wound has shown to improve early
      postoperative pain in various surgical procedures.

      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in
      animal and human models of pain.

      It has been mentioned in a systematic review that it may be worthwhile to further study the
      role of supplemental magnesium in providing perioperative analgesia, because this is a
      relatively harmless molecule, is not expensive and also because the biological basis for its
      potential antinociceptive effect is promising.

      These effects are primarily based on physiological calcium antagonism, that is
      voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism
      of N-methyl-D-aspartate (NMDA) receptors.

      there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to
      bupivacain
    

Intervention name(s): Bupivacaine magnesium; Bupivacaine only
Intervention type(s): Drug; Drug
Intervention description(s): bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours; bupivacaine 0.125% infusion in the presternum , for 48 hours
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: post open heart surgery pain alleviation
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy
Condition: Obesity, Abdominal; Lung Disease
MeSH terms: Lung Diseases; Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the hospitalized patients with increased
      waist circumference exhibit cardiorespiratory alterations after chest physical therapy.
    

Detailed description: 
      The physiotherapist assessment will consist of anthropometry (body mass index, abdominal
      circumference, adipometer); chest inspection and palpation, vital signs (blood pressure,
      heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and
      later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and
      pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be
      divided into four groups according to waist circumference (increased or not, with respect to
      cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this
      assessment, chest physical therapy will begin according to the protocol for obstructive and
      restrictive respiratory disorders. The treatment will have an average duration of 30 minutes.
      At the end of treatment (single session) the patient will be assessed again after five and
      thirty minutes.
    

Intervention name(s): Chest physiotherapy chest wall expansion; Chest physiotherapy airway clearance modality
Intervention type(s): Other; Other
Intervention description(s): chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).; The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
Other intervention name(s): Chest physiotherapy; Chest physical therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Physical Therapy Modalities; Respiration Disorders; Respiratory Therapy
Anti-Mullerian Hormone - At My Home
Condition: Fertility Risk
Study type: Interventional

Summary: 
      The AMH^2 (Anti-Mullerian Hormone - At My Home) study is a head-to-head-to-head validation
      study aiming to evaluate the concordance of AMH levels found in blood collected via three
      different routes: collected at-home using the TAP II device, drawn through standard
      venipuncture techniques, and collected with the ADx card, another at-home collection device
      widely available on the market for commercial use.
    

Detailed description: 
      Today, information regarding fertility potential is challenging to obtain for healthy women;
      clinically meaningful in-clinic testing is limited by physician availability and patient
      willingness to undergo testing in-clinic. Meanwhile, at-home hormonal bloodwork relies on the
      use of an ADx card, and is not widely accepted as clinically reliable by the medical
      community. The Sponsor is developing a comprehensive home fertility assessment to enable
      couples to proactively estimate and manage their fertility and family building options.
      Accurate and reliable at-home AMH testing is necessary to reach this goal.

      This study aims to validate the clinical excellence and medical accuracy of blood drawn via
      the TAP II device relative to a standard in-clinic venipuncture draw and other options
      available on the market to support emerging telemedicine care models. In doing so, the
      Sponsor may receive CLIA validation for the TAP II in AMH testing and commercialize a Lab
      Developed Test.
    

Intervention name(s): Blood draw through TAP II; Blood draw through ADx cardT; Blood draw through standard venipuncture
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Two self-administered blood draws through TAP II device; One self-administered ADx card blood draw; One phlebotomist-performed standard venipuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The general aim of the trial is to determine the safety, tolerability and pharmacologic
      profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously
      to patients with chronic plaque psoriasis
    


Intervention name(s): AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 intravenous infusion; AbGn168 subcutaneous injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose intravenous infusion; single dose intravenous infusion; single dose intravenous infusion; single dose intravenous infusion; single dose intravenous infusion; single dose intravenous infusion; single dose intravenous infusion; single dose subcutaneous injection
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
Condition: Relapsed or Refractory Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine
      the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute
      lymphoblastic leukemia.
    

Detailed description: 
      This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine
      the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute
      lymphoblastic leukemia. The study will have the following sequential phases: Screening,
      Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and
      Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19
      cell infusion.
    

Intervention name(s): single dose of CNCT19
Intervention type(s): Biological
Intervention description(s): Dose A: 0.25 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Dose B: 1.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Dose C: 2.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer
Condition: Fasting; Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a
      supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high
      metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life,
      reduction of side effects and possible reduction in tumor progression.
    

Detailed description: 
      Prostate cancer is in Germany with approximately 25% of all cancers the most common cancer
      among man. Assumably there will be an increase in prostate cancer in the next few years
      because of demographic factors. The progressive metastatic prostate cancer often develops an
      androgen resistance. This so-called Castration-Resistant Prostate Cancer (CRPC) is not
      responsive to androgen deprivation therapy. Depending on symptoms and progression first-line
      chemotherapy - docetaxel and abiraterone are available.

      Intermittent fasting as a form of caloric restriction has been studied most extensively
      experimentally in recent years. It showed consistent beneficial effects on relevant
      inflammatory and oncological pathways. In the field of preclinical oncology research groups
      have recently focused on intermittent fasting with chemotherapeutic treatment and promising
      experimental data have been published. In summary, the combination of fasting and
      chemotherapy was more effective in various cancer animal models than chemotherapy alone.
    

Intervention name(s): Fasting; Control
Intervention type(s): Other; Other
Intervention description(s): Patients realize a 60h-modified fasting (36h before and 24h after chemotherapy) with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. Between chemotherapy a Mediterranean diet with nutrition training individually and in small groups by trained nutritionists at the Study Centre will be practiced.; Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fasting; Prostatic Neoplasms; Complementary Therapies; Urology
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, phase I study.
    

Detailed description: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of
      Telitacicept in Chinese patients with systemic lupus erythematosus.
    

Intervention name(s): Telitacicept; standard therapy
Intervention type(s): Biological; Drug
Intervention description(s): subcutaneous injection; A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.
Other intervention name(s): RC18
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; Telitacicept; Pharmacokinetics; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases
A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a
      protein made in the body to response to a foreign substance) response following tetanus,
      diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4.
    


Intervention name(s): Nipocalimab; Tdap; PPSV23
Intervention type(s): Drug; Biological; Biological
Intervention description(s): Nipocalimab will be administered as an IV infusion.; Tdap will be administered as an IM injection.; PPSV23 will be administered as an IM injection.
Other intervention name(s): JNJ-80202135; GSK Boostrix; MSD Pneumovax23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Aspirin Dosing in Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Since diabetic platelets are characterized by an enhanced turnover rate, it may be
      hypothesized that an increase in the frequency, rather than the dose, of drug administration
      may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this
      may enable COX-1 blockade of newly generated platelets. However, how different dosing
      regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has
      been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate
      how increasing the frequency of aspirin administration, remaining within the daily
      recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with
      coronary artery disease.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diabetes mellitus, coronary artery disease, aspirin therapy
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control,
      compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine
      and ethinyl estradiol (NLGM / EE).
    

Detailed description: 
      A multicenter, open label, descriptive study. Five hundred requiring contraception will
      receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after
      the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive
      efficacy will be assessed by the Pearl Index and by life table analysis. To assess
      satisfaction with the weekly transdermal contraceptive patch, this method will be compared to
      the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary
      outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2
      contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a
      third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of
      NLGM and 20 mcg of EE per day.
    

Intervention name(s): Norelgestromine (NLGM)/ethinyl estradiol (EE)
Intervention type(s): Drug
Intervention description(s): Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).
Intervention MeSH terms: Ethinyl Estradiol; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Hormonal patch; Norelgestromine; Ethinyl estradiol
Milk Components and Metabolic Syndrome
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Milk contains a vast number of bioactive components that have been suggested to have a
      positive impact on human health, of special interest is the effects related to metabolic
      syndrome and obesity but the effect of the individual milk components is not clear. This
      study examine whether it is beneficial for overweight and obese children to increase the
      intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.

      The participants will be randomized to receive skim milk, whey milk drink, casein milk drink
      or mineral water for 3 mo. They will be examined at baseline, end of intervention and
      followed up 3 month later.
    


Intervention name(s): Milk Components and Metabolic syndrome
Intervention type(s): Behavioral
Intervention description(s): 1 liter per day of the test drinks for 3 mo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity; metabolic syndrome; milk components; casein; whey; children; adolescent
Comparison of 2 Different Flow Rates During Oocyte Retrieval
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of different flow rates during oocyte
      retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.
    

Detailed description: 
      In the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42
      ml/sec or 0.62 ml/sec flow rate.

      The primary endpoint will be the number of oocytes retrieved, while secondary outcomes will
      include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of
      mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean
      oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of
      perivitelline space (PVS), structure of zona pellucida (ZP) and polar body (PB) morphology),
      fertilization rate (number of fertilized oocytes/number of mature oocytes), number of
      blastocysts and blastulation rate (number of blastocysts/number of 2PN).

      Patients aged 18-43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on
      the day of oocyte retrieval will be eligible for inclusion in the study.

      Prior to oocyte retrieval in eligible patients their left and right ovary will be randomly
      allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. Randomisation with
      minimisation will be employed.

      The specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum
      pump accordingly. A study nurse will be responsible for adjusting the aspiration pressure of
      the vacuum pump depending on randomization. The doctor performing the oocyte retrieval will
      not be aware of the flow rate used in each ovary.

      All follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an
      open flushing technique, using a 16G double-lumen needle.

      Data will be registered regarding the number of flushes required to retrieve a COC, the
      morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the
      blastocyst stage.
    

Intervention name(s): Oocyte retrieval with low aspiration flow rate; Oocyte retrieval with high aspiration flow rate
Intervention type(s): Procedure; Procedure
Intervention description(s): All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.42 ml/sec.; High aspiration flow rate All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.62 ml/sec.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Flow rate; Aspiration pressure; Oocyte retrieval