bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)
Condition: Infant,Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this research is to determine the effect of premature birth on later heart
      function and metabolism.
    

Detailed description: 
      The purpose of this study is to determine the effects of premature birth on cardiac function,
      cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using
      cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration
      studies.
    

Intervention name(s): Pulmonary Function Testing; Electrocardiogram; Positron Emission Tomography; Magnetic Resonance Imaging
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Subjects will undergo Spirometry and Plethysmography; Subjects will undergo an electrocardiogram to ensure sinus rhythm; Subjects will undergo positron emission tomography to detect images of the heart; Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Young adults born premature (some of them are registered on the National Lung Project) and Healthy Controls will undergo pulmonary function testing, cardiac positron emission tomography, and cardiac magnetic resonance imaging.
Masking: None (Open Label)
Primary purpose: Other
Keywords: premature adults; premature; premature lung function; premature cardiac function; MRI; PET
Generation of Biological Samples Positive to Triptorelin for Anti-doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Androgens are used for doping purpose because they can increase muscle mass and strength.
      These drugs are included in the list of prohibited substances of the World Anti-Doping Agency
      (WADA). The prohibition of its use has given rise to a great variety of strategies of
      indirect androgenic doping, whose purpose is to produce a sustained increase in endogenous
      testosterone.

      Triptorelin acetate is a gonadotropin-releasing hormone (GnRH) agonist. Daily subcutaneous
      administration of triptorelin causes an initial increase in circulating levels of luteinizing
      hormone (LH) and follicle stimulating hormone (FSH), producing a transient increase in
      testosterone levels. However, prolonged daily administration results in a paradoxical
      decrease in LH and FSH levels due to desensitization of GnRH receptors, decreasing
      testosterone production to levels similar to castration.

      Thus, the initial flare reaction produced by triptorelin administration could be used by
      athletes as an indirect androgenic doping method to stimulate the synthesis of endogenous LH
      and testosterone with the aim of improving physical performance.

      Hypothesis:

      Subcutaneous administration of triptorelin in healthy subjects allows obtaining positive
      urine samples that will be used to identify analytical strategies for doping detection.
      Triptorelin concentrations and its metabolites can be measured in urine.

      Objectives:

      Primary objective: To measure triptorelin concentrations in urine samples for anti-doping
      control.

      Secondary objectives: To identify triptorelin metabolites in urine. To explore the time
      window in which the drug or its metabolites can be detected in urine after administration.

      Methods:

      Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition
      (triptorelin) administered subcutaneously in a single dose to 2 subjects.
    


Intervention name(s): Triptorelin
Intervention type(s): Drug
Intervention description(s): Subjects receive a single subcutaneous dose of 0,1 mg of Triptorelin acetate.
Intervention MeSH terms: Triptorelin Pamoate
Intervention model: Single Group Assignment
Intervention model description: The study model consists on a single group of subjects who receive the treatment condition (triptorelin)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Triptorelin; Anti-doping control; Athletic performance; Gonadotropin-releasing hormone
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Condition: Pediatric Brain Stem Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypofractionated radiotherapy reduce the patient and family burden through decreasing the
      overall treatment time. This study is to evaluate the clinical end results of the
      hypofractionated radiotherapy in DIPG compared to the conventional treatment. The
      non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital,
      stay or engagement, for more than its half with the same results.
    

Detailed description: 
      In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic
      pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up
      to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.

      This schedule offers a reduction in patient burden, especially preferable in children with a
      poor compliance and performance status. The non-inferiority of the hypofractionated regimen
      in its clinical end-results, with the reduction of the overall treatment time to less than
      its half will decrease the burden for the patient, his/her family and the treating
      department. This will be considered as added value without compromising the survival or
      increasing side effects.
    

Intervention name(s): Hypofractionated radiotherapy; Conventional arm
Intervention type(s): Radiation; Radiation
Intervention description(s): A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week; A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DIPG; Hypofractionated Radiotherapy; Radiotherapy; Median survival
An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether aripiprazole injection into the shoulder or
      the buttocks produces similar effects in the body
    

Detailed description: 
      Extended-release gluteal intramuscular (IM) injection of aripiprazole has been tested in
      subjects with schizophrenia for safety and tolerability. This study will compare the gluteal
      IM aripiprazole injection with deltoid IM aripiprazole injection for safety and tolerability.
    

Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): One injection of 400 mg aripiprazole IM depot
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Schizophrenia, extended release antipsychotic
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Condition: Osteosarcoma Metastatic
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated
      dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients
      with relapsed/progressive osteosarcoma metastatic to the lung.
    


Intervention name(s): Cisplatin liposomal
Intervention type(s): Drug
Other intervention name(s): SLIT Cisplatin
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteosarcoma; relapsed; progressive; metastatic; lung
A Comparison of the Littler Flap With the Bipedicled Nerve Flap
Condition: Soft Tissue Defect of Digit; Nerve Injury
Study type: Interventional

Summary: 
      A retrospective study is conducted with 59 patients who has a combination of soft tissue and
      digital nerve defects following trauma treated using the Littler flap or bipedicle nerve
      flap.Patients are divided into two groups. The group reconstructed with the Litter flap
      includes 26 patients and the group reconstructed with the bipedicle nerve flap includes 33
      patients.Discriminatory sensation, pain and cold intolerance of the reconstructed finger, and
      patient satisfaction were evaluated.
    

Detailed description: 
      At final follow-up, we measured the sensation of the pulp of the reconstructed finger and the
      flap using the static two-point discrimination (2PD) test and Semmes-Weinstein monofilament
      (SWM) examination. The test points were at the centers of the radial and ulnar portions of
      the finger pulp and the flap. Cold intolerance of the injured and donor fingers was assessed
      using the self-administered Cold Intolerance Severity Score questionnaire. The maximum score
      was 100; scores were grouped as mild (0 to 25), moderate (26 to 50), severe (51 to 75), and
      extremely severe (76 to 100). Pain was given subjectively by the patient using a grading
      system that included grade 1, none; grade 2, mild, no interference with daily activities;
      grade 3, moderate, patient works but has some limitation in use of the hand because of pain;
      and grade 4, severe, cannot work or use hand. The Tinel sign on the donor and recipient sites
      was graded as follows: grade 1, none; grade 2, mild, slight tingle; grade 3, moderate, very
      uncomfortable; and grade 4, severe, patient unable to use hand because of any stimulation of
      the neuroma. Finally, patients reported their satisfaction with functional recovery of the
      injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a
      5-point response scale. All tests were performed by an independent senior hand surgeon.
    

Intervention name(s): nerve flap
Intervention type(s): Procedure
Intervention description(s): sensory reconstruction via a nerve graft included in the flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nerve flap; sensory reconstruction; nerve repair
A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
Condition: Renal Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD
      patients
    

Detailed description: 
      This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind,
      placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 to treat anemia in
      non-dialysis-dependent chronic kidney disease patients.
    

Intervention name(s): AND017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orally, 3 times per week in Period 1 and randomize to TIW or QW group at the same dose in Period 2; Orally, 3 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
Condition: Chronic Myeloid Leukemia; Acute Myelogenous Leukemia; Myelodysplasia; Acute Lymphocytic Leukemia; Severe Aplastic Anemia; Non-Hodgkin's Lymphoma; Lymphoproliferative Disease; Multiple Myeloma; Advanced Myeloproliferative Disease
MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Aplastic; Myeloproliferative Disorders; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the safety and efficacy of performing
      unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative
      therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to
      demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40%
      at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to
      demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.
    


Intervention name(s): Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
Intervention type(s): Drug
Intervention description(s): Day Preparative Regimen for GVHD Prophylaxis
7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
3 Fludarabine 30 mg/m(2)IV
2 REST Tacrolimus 0.01 mg/kg CIVI
1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
1 Methotrexate 5mg/m(2)IV
3 Methotrexate 5mg/m(2)IV
6 Methotrexate 5mg/m(2)IV
7 G-CSF 5mcg/kg SQ daily
11 Methotrexate 5mg/m(2)IV
90 Evaluate Response
Intervention MeSH terms: Methotrexate; Fludarabine phosphate; Fludarabine; Busulfan; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Matched Unrelated Donor; Stem Cell Transplantation; Busulfan; fludarabine; Hematopoietic Disorder
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Condition: Spinal Deformity; Spinal Fractures; Spinal Injuries; Kyphosis
MeSH terms: Kyphosis; Fractures, Bone; Spinal Fractures; Spinal Injuries
Study type: Observational

Summary: 
      The objective of this investigation is to confirm the results obtained in a pilot study
      showing that certain radiological parameters based on computed tomography (CT) scans seem to
      reliably detect posterior ligament complex (PLC) injury without the need for Magnetic
      Resonance Imaging (MRI)
    

Detailed description: 
      Integrity of posterior ligament complex (PLC) has an important bearing on the treatment
      strategies for thoracolumbar (TL) fractures. Magnetic Resonance Imaging (MRI) is the gold
      standard to confirm PLC injury. The routine use of MRI has its limitations especially since
      in most trauma centers MRI is not the primary assessment for TL fractures due to reduced
      availability, increased cost and its adverse applicability in trauma setting and in case of a
      polytrauma. In contrast computed tomography (CT) scans are an integral part of trauma
      evaluation protocols, are accurate in spine fracture diagnosis and are performed in less
      time, making them suitable to assess polytrauma scenarios. In a recent pilot study, a number
      of radiological parameters based on CT scans have shown to reliably detect PLC injury when
      compared to MRI. The aim of the study is to reconfirm and validate these CT based parameters
      to assess PLC injury compared to MRI.
    

Intervention name(s): Retrospective radiological evaluation
Intervention type(s): Other
Intervention description(s): Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participating study sites will retrospectively identify all eligible patients in the
        medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If
        required by local regulations, patients choosing to participate will sign and date an
        informed consent form (ICF).
      
Keywords: Posterior ligamentous complex; Thoracolumbar fractures; Interspinous distance; Local kyphosis
Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI
Condition: Facial Wrinkles
MeSH terms: Facies
Study type: Interventional

Summary: 
      This is a study to assess how safe and effective an investigational product, Belotero® is in
      people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds
      are wrinkles on the face that go from outside of the nostrils to the edges of the mouth.
    

Detailed description: 
      The Fitzpatrick Skin Phototype Scale goes from number 1 (I), which is the very lightest skin
      tone, to number 6 (VI) which is the very darkest skin tone. This study is to determine the
      safety and effectiveness of Belotero® in people with skin phototypes of 1(I)thru 6 (VI).
    

Intervention name(s): Belotero®
Intervention type(s): Device
Intervention description(s): Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer
Other intervention name(s): Nasolabial folds
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasolabial folds
The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Condition: Amputation; Diabetic Foot; Valve Disease, Aortic; Valve Heart Disease
MeSH terms: Heart Diseases; Diabetic Foot; Heart Valve Diseases; Aortic Diseases; Aortic Valve Disease
Study type: Observational

Summary: 
      The goal of this observational study is to learn about the association between cardiac valve
      calcification and the 1-year mortality after lower-extremity amputation in diabetic patients.
      Diabetic patients requiring lower-extremity amputation were retrospectively studied.
      Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using
      echocardiography at baseline. One-year follow-up was conducted and included clinical visits,
      hospital record assessment, and telephone reviews to obtain the survival status of patients.
      Researchers compare the survival group to the mortality group to study the relationship
      between the cardiac valve calcification and mortality.
    

Detailed description: 
      This study aimed to investigate the association between cardiac valve calcification and
      1-year mortality in diabetic patients after lower-extremity amputation. The investigator
      recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for
      diabetic foot ulcers that needed amputation surgery. Clinical characteristics of each patient
      and the laboratory examination were collected before surgery. Cardiac valve calcification was
      assessed at baseline. This study obtained the survival status of patients within one year
      through outpatient follow-up and telephone follow-up. Researchers compared the survival group
      to the mortality group to see if the mortality group had a higher prevalence of heart valve
      calcification.
    

Intervention name(s): calcified cardiac valve
Intervention type(s): Other
Intervention description(s): patients have cardiac cardiac valve before surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigator recruited consecutive patients who were admitted to the Sun Yat-sen
        Memorial Hospital for diabetic foot ulcers that needed amputation surgery between July 2017
        and March 2021 and were followed up for 1 year after amputation surgery
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Condition: Degenerative Joint Disease of Hip
MeSH terms: Joint Diseases; Osteoarthritis; Osteoarthritis, Hip
Study type: Observational

Summary: 
      The purpose of this prospective, multicenter, single arm study is to confirm the long-term
      safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by
      evaluating long-term (10 years after surgery) follow-up results.
    

Detailed description: 
      This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips
      enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study.
      The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox
      delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips,
      enrolled and followed in a European Post-market Study ("A prospective, multicenter,
      non-randomized, clinical outcome study of the R3 Acetabular System in patients with
      degenerative hip disease").

      The purpose of this prospective, multicenter, single arm study is to confirm the long-term
      safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by
      evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the
      following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant
      survivorship at 10 years post surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This clinical study can fulfill its objectives only if appropriate subjects are enrolled.
        All relevant medical and non-medical conditions should be taken into consideration when
        deciding whether a particular patient is suitable.
Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes
Condition: Type1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one
      Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility
      and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system
      (intervention group) compared to standard of care therapy (control group).
    

Detailed description: 
      Women will be recruited with a singleton pregnancy up to 12 weeks gestation. Participants
      will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of
      insulin pump without closed-loop or multiple daily insulin injections). Participants will be
      stratified according to study center, baseline Hba1c, and method of insulin delivery (pump or
      injections). Participants will be followed-up till delivery. To account for differences in
      the type of continuous glucose monitoring (CGM) used between the intervention group and the
      control group, the same CGM system as in the 780 insulin pump group (Guardian™ Sensor 3 and
      once available the Guardian 4 sensor) will be used in a blinded manner in the control group
      to collect CGM data during at least four different time points in pregnancy: at 14-17 weeks,
      20-23 weeks, 26-29 weeks and 33-36 weeks.
    

Intervention name(s): 780G; standard of care
Intervention type(s): Device; Device
Intervention description(s): 780G closed-loop insulin delivery system (Medtronic); continue with standard of care treatment (pump without closed-loop or MDI)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1/1 randomization to 780G or continue with standard of care
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: closed-loop insulin delivery