bioihbjkbjnl/mcl2 huggingface dataset:
Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Condition: Ovarian Hyperstimulation Syndrome; Frozen-thawed Embryo Transfers
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Observational

Summary: 
      Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of
      ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between
      endometrium and embryo, which is fundamental for pregnancy.

      There are several FET protocols, including hormonal replacement therapy cycle (HRT), which
      enable clinicians to adapt the day of embryo transfer.

      However, increase in spontaneous miscarriages was observed with this latter protocol compared
      to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in
      relation with the lack of physiological corpus luteum.

      Then, Clinicians interrogate about measuring serum progesterone in order to adjust their
      treatment and/or transfer date. Various studies have shown thresholds below and/or above
      which pregnancy or live birth rate were lowered.

      The main objective is to find a serum progesterone threshold on the day of embryo transfer
      above which live birth rate is increased. The secondary objectives are to analyze the factors
      associated with increased serum progesterone on the day of transfer, to analyze the
      miscarriage rate, and impact of change on luteal phase support on day 12.
    


Intervention name(s): Identification of predictive factors
Intervention type(s): Other
Intervention description(s): Evaluation of the following variables : mother age (years), father age (years), serum progesterone (ng/ml), mother body mass index (kg/m2), serum Antimüllerian hormone (AMH) (ng/ml), infertility etiology (yes/no): 4 categories: idiopathic etiology, mixed origin infertility, male infertility, female infertility; smoker status among mothers (yes/no).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patient having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal
        replacement therapy
      
Keywords: serum progesterone; frozen-thawed embryo transfer; live birth rate
Cardiopulmonary Exercise Testing in Interstitial Lung Disease
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom.
      Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate
      cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.
    


Intervention name(s): cardiopulmonary exercise test
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with Interstitial lung diseases
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to assess the safety and effectiveness of the sirolimus
      coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native
      coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both
      stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.
    

Detailed description: 
      This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm
      design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to
      the bare metal BxTM VELOCITY stent, both mounted on the Raptorâ Rapid Exchange Stent Delivery
      System. A total of 220 patients will be entered in the study and will be randomized on a 1:1
      basis. Patients will be randomized to the coated or uncoated BX VELOCITY stent. Therefore,
      neither the Investigator nor the patient will know which stent will be implanted. Patients
      will be followed for twelve months post-procedure, with all patients having a repeat
      angiography at 6 months. An ancillary study with in-stent IVUS measurements at 6 months
      follow-up will be performed in all patients of 6 pre-selected clinical sites. It is assumed
      that these sites will enroll more than 90 patients.
    

Intervention name(s): Sirolimus coated Bx Velocity™; Bare metal Bx Velocity™
Intervention type(s): Device; Device
Intervention description(s): drug-eluting stent; bare-metal stent
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to investigate whether the infusion of a medicinal plant
      (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of
      type 2 Diabetes patients.
    

Detailed description: 
      Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult
      population. In many developing countries, this condition is regarded as major public health
      problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related
      with a condition of insulin resistance and relative insulin deficiency. As Diabetes
      progresses, medications are necessary to control glucose levels.

      The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus
      verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose
      levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been
      used as potential medication for controlling glucose levels in Diabetes patients. Few studies
      have explored this effect related to Cissus verticillata L.infusion, though it has been
      indicated by folk medicine of some Latin American countries.
    

Intervention name(s): glibenclamide; medicinal plant infusion
Intervention type(s): Drug; Other
Intervention description(s): 5 mg as pills, taken daily during the morning for 60 days; INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.
Other intervention name(s): Glibenclamida, Legrand GE; popular plant name: Insulina
Intervention MeSH terms: Glyburide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes,; medicinal plants,; glucose
Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Condition: Nerve Block; Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study the investigators would like to show that when patients undergo upper limb
      surgery under supraclavicular brachial plexus block, additional blocking of the
      Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet
      pain.
    

Detailed description: 
      The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm.
      Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet
      pain is complex and the study team hypothesize that blocking the ICBN has no impact on
      tourniquet pain. Patients will receive a supraclavicular block and be divided into two
      groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will
      receive a supraclavicular block as their primary anesthetic and then be divided into two
      groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics,
      conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will
      be the primary measures of this study.
    

Intervention name(s): Receive ICBN with ropivacaine; No ICBN block
Intervention type(s): Drug; Behavioral
Intervention description(s): ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.; The site of injection will be prepped with tinted chlorhexidine
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Intercostobrachial Nerve Block; Tourniquet Pain; Upper Limb Surgeries
Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers
Condition: Lipid Metabolism Disorder
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare laboratory tests profiles of a botanic drug
      XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy
      male volunteers between 18 and 50 years of age.
    

Detailed description: 
      Twenty (20) healthy male subjects will be enrolled and assigned to either XZK group or
      Lovastatin group at a 1:1 ratio at one site in the USA.
    

Intervention name(s): XueZhiKang; Lovastatin
Intervention type(s): Drug; Drug
Other intervention name(s): XZK; Mevacor
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Predictors of Teen Smoking-cessation
Condition: Cigarette Smoking
Study type: Observational

Summary: 
      The primary objective of this research is to explore relations between impulsive behavior and
      smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.

      It is hypothesized that teens who do not successfully stop smoking (or who drop out of the
      treatment program) will be more impulsive (from measures taken just prior to treatment) than
      those who do successfully stop or significantly reduce rate of smoking.
    


Intervention name(s): Not-On-Tobacco smoking cessation program
Intervention type(s): Behavioral
Intervention description(s): Adolescent quit-smoking program; Not-On-Tobacco
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be adolescent smokers between the ages of 13-19 recruited from local
        high-schools (Franklin county; Pike county, and Scioto County in Ohio), shopping malls, and
        newspaper ads.
      
Keywords: adolescent quit-smoking program.
Escitalopram as a Treatment for Pain in Polyneuropathy
Condition: Pain; Polyneuropathies
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is
      a relatively new drug used in the treatment of depression. Escitalopram's action mechanism on
      the brain suggests that escitalopram also may have an effect on neuropathic pain. This study
      will test the efficacy of escitalopram in patients with painful polyneuropathy.
    

Detailed description: 
      Tricyclic antidepressants appear to be the most efficacious treatment of painful
      polyneuropathy. However, these drugs are contraindicated in some patients and a substantial
      number of patients decline treatment due to side-effects. Therefore, effective drugs that are
      better tolerated are needed. Clinical and basic research has demonstrated that drugs with
      serotonergic action can alleviate neuropathic pain. Escitalopram increases serotonin
      concentration in the central nervous system, suggesting that it might be a potential
      alternative to current treatments of neuropathic pain. The aim of this study is to test if
      escitalopram would relieve painful polyneuropathy.

      Comparisons: Treatment with 20 mg escitalopram daily will be compared in a cross-over design
      with placebo. Each treatment period will last 6 weeks. During the last week of each treatment
      period, the dose will be tapered.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: polyneuropathies; pain; drug effects; escitalopram; serotonin uptake inhibitors
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial was to evaluate the effect of cortical bone
      decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.
    

Detailed description: 
      Background: The purpose of the current study was to evaluate the effect of cortical bone
      perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.

      Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with
      osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical
      bone at the area of regeneration was perforated using a #2 high speed round bur. No
      decortication of cortical bone was performed in the control group (n=7). Subsequently,
      defects were augmented by guided bone regeneration using resorbable membrane and bovine bone.
      After a healing period of 7 months, implant sites were created and trephine cores harvested
      for histological and histomorphometric analysis of the grafted areas.
    

Intervention name(s): Decortication
Intervention type(s): Procedure
Intervention description(s): cortical bone perforation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: histomorphometry
A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi center, open label, parallel group, single administration, phase I trial, in
      subjects with mild, moderate or severe renal impairment and a control group with normal renal
      function.
    

Detailed description: 
      Current diabetes therapy does not stop progression of the disease and the development of
      diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal
      impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has
      been established that chronic (sub)clinical inflammation is crucial for the onset and
      progression of DM.

      CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the
      cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte
      emigration from the bone marrow, activates monocytes and macrophages and directs their
      migration to sites of inflammation. Recent animal studies and clinical trials indicate a
      critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a
      potential target for therapeutic intervention in DM. Finally, protein overload and oxidative
      challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli,
      thereby accelerating the progression of diabetic nephropathy.

      As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to
      evaluate the role of renal impairment for adequate dosing recommendations in the planned
      target population.
    

Intervention name(s): NOX-E36
Intervention type(s): Drug
Intervention description(s): All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal impairment; NOX-E36
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in
      subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin
      combination therapy.

      The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication
      in subject who are inadequately controlled with metformin and DPP4 inhibitor will be
      evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in
      Korea.
    

Detailed description: 
      Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the
      following groups and primary efficacy variable analyzed at week 16.

      group 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt
      week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo
      + sitagliptin (with switching placebo to metformin at week 16)

      After 16 week of treatment, all subjects in 3 groups will be treated as triple combination of
      acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed.

        1. Primary Endpoint Changes in HbA1c (hemoglobin A1c) at 16 week from baseline between
           group1 vs grou2

        2. Secondary Endpoints (1) Changes of HbA1c at 24 week between 3 groups (2) Changed of
           post-prandial blood glucose at 2 hour (ppg2h) at 16, 24 week

      for exploratory purpose, following data will be collected and analyzed

        1. continuous glucose monitoring system (CGMS) data among selected subjects in 3 groups

        2. mixed meal tolerance test in only available institution. (glucose, insulin, GLP-1, GIP,
           glucagon ) among selected subjects in group 1 and group 2

        3. oxidative stress markers (8-OHdG, nitrotyrosin, CML)

        4. self monitoring of blood glucose
    

Intervention name(s): Acarbose; Placebo acarbose; placebo metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.; acarbose placebo; metformin placebo
Other intervention name(s): triple combination; dual combination (metformin+sitagliptin); dual combination (acarbose + sitagliptin)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acarbose; ACADEMIC
Detection of COVID-19 (SARS-CoV-2) in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)
Condition: COVID
Study type: Interventional

Summary: 
      The objective of this study is to look for the presence of SARS-CoV-2 in the semen of
      patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.
    

Detailed description: 
      This is a prospective monocentric, open-label, prospective study of male patients with
      CoV-2-SARS.
    

Intervention name(s): diagnostic
Intervention type(s): Diagnostic Test
Intervention description(s): The principle of this study is to propose to patients in whom a COVID-19 infection is suspected and who are screened for the disease, the joint search for the virus in the semen.
Intervention model: Single Group Assignment
Intervention model description: This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.
Masking: None (Open Label)
Primary purpose: Diagnostic
Microvascular Dilatation After Endogenous Induced Hyperinsulinemia
Condition: Hypertension; Obesity
MeSH terms: Hypertension; Obesity
Study type: Interventional

Summary: 
      In this study we will examine if the insulin-induced microvascular effects will occur after a
      physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological
      importance of the insulin-induced microvascular dilatation can be elucidated. In this study
      we hypothesize that oral glucose intake and consequently the endogenous induced
      hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy
      normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular
      dilatation, resulting from this physiological induced hyperinsulinemia, will be less in
      hypertensive and obese subjects compared to healthy controls.
    


Intervention name(s): Glucose solution; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water); single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Microcirculation; Insulin; Hypertension; Obesity
A Study of JNJ-64300535 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly
      electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy
      participants.
    


Intervention name(s): JNJ-64300535
Intervention type(s): Biological
Intervention description(s): JNJ-64300535 injection will be administered intramuscularly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other