bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Agili-C Biphasic Implant in the Knee Joint
Condition: Cartilage Diseases; Osteochondritis Dissecans
MeSH terms: Osteochondritis; Osteochondritis Dissecans; Cartilage Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the performance of the Agili-C implants. The study
      hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and
      cartilage-bone joint surface defects.
    

Detailed description: 
      Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the
      treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are
      to be included in the study. Patients suffering from isolated, single and focal cartilage or
      osteochondral defect at the knee joint are considered for study inclusion.
    

Intervention name(s): Agili-C Bi-phasic Implant; mini-arthrotomy
Intervention type(s): Device; Procedure
Intervention description(s): The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone).
The implant will be inserted gently in a pressed fit manner.; The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded.
Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded.
Other intervention name(s): Agili-C implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cartilage; bone
Repeated Challenge of Insufficient Sleep: Endothelial Effects
Condition: Repeated Short Sleep Schedule
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to
      stay. Americans are working more and more, frequently at multiple jobs. The pattern of short
      sleep during the week followed by attempts to recover on the weekend is in common practice,
      but we know little of the associated health risks. What is the cost in terms of increasing
      known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and
      is this cost compounded with repetition, without adequate recovery? Evidence is accumulating
      to suggest that short sleep duration is linked to the development of metabolic and
      inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the
      development of cardiovascular disease include impaired vascular function and inflammation.
      The current proposal is designed to investigate the effects of repeated periods of short
      nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep
      opportunity per night), and each cycle of short sleep followed by a single night of recovery
      sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and
      microcirculatory vasodilation will be assessed using perfusion imaging techniques. The
      dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function,
      will also be investigated.
    

Detailed description: 
      Due to work, family, social and community obligations, millions of Americans cut back on
      sleep for several nights in a row before having an opportunity to catch up. When the
      opportunity does arise, it may only be for a single night, before the cycle of insufficient
      sleep repeats. This study investigated what happens to human biology when insufficient sleep
      becomes chronic and opportunities for recovery sleep are intermittent. It also investigated
      recovery sleep itself, and the biological processes involved in reversing the effects of an
      accumulated sleep deficit due to insufficient sleep duration.
    

Intervention name(s): repeated cycles of short sleep
Intervention type(s): Behavioral
Intervention description(s): - 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
ProQuad® Intramuscular vs Subcutaneous
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two
      doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in
      terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days
      following the second dose of ProQuad®

      Secondary objectives:

        -  To describe the antibody response rates to measles, mumps, rubella and varicella
           measured 30 days following the first dose of ProQuad® administered by IM or SC route,

        -  To describe the antibody titres to measles, mumps, rubella and varicella at 30 days
           following the first dose and at 42 days following the second dose of ProQuad® both
           administered by IM or SC route,

        -  To describe the safety profile of two doses of ProQuad® both administered by IM or SC
           route.
    


Intervention name(s): ProQuad®
Intervention type(s): Biological
Intervention description(s): Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
APSV in Vaccinia Naive Adults
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The study seeks to define, with precision, the safety and efficacy of APSV, two dose
      potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a
      classic �take� as defined by formation of a lesion at the injection site consistent with the
      �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed.
      The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of
      live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with
      takes for the Dryvax vaccine and is considered to be cross-protective for other
      orthopoxviruses, including variola. The study also seeks to characterize preliminarily the
      cell mediated immune (CMI) response to APSV (as compared to Dryvax).
    

Detailed description: 
      A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2
      dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single
      vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered
      a vaccination with Dryvax at the end of the study.
    

Intervention name(s): Aventis Pasteur Smallpox Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Smallpox; Aventis Pasteur; Vaccine
A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to learn if hemin can increase the production of heme oxygenase 1 and
      improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric
      emptying (gastroparesis).
    

Detailed description: 
      Therapeutic options for management of diabetic gastroparesis are limited. Failure to maintain
      upregulation of heme oxygenase 1 (HO1) leads to loss of interstitial cells of Cajal and
      delayed gastric emptying in diabetic non-obese diabetic mice.

      HO1 is an enzyme which protects cells from physical, chemical, and biologic stress. In mice
      with diabetes and slow gastric emptying, hemin increases HO-1 activity and improves gastric
      emptying. Hemin is produced from red blood cells and is approved by the Food and Drug
      Administration for treating acute porphyria, which is an inherited condition caused by an
      enzyme deficiency. Hemin is not approved by the Food and Drug Administration for treating
      gastroparesis.

      In this study subjects were randomized to intravenous hemin, prepared in albumin, or albumin
      alone. After infusions on days 1, 3, and 7, weekly infusions were administered for 7 weeks.
      Assessments included blood tests for HO1 protein and enzyme activity levels, gastric emptying
      with 13^C-spirulina breath test, autonomic functions (baseline and end), and gastrointestinal
      symptoms every 2 weeks.
    

Intervention name(s): Hemin; Albumin
Intervention type(s): Biological; Biological
Intervention description(s): 10 iv infusions for 8 weeks; 10 iv infusions for 8 weeks
Other intervention name(s): Panhematin®, (Ovation Pharmaceuticals, Deerfield, IL); Albumin (Human) 25% Solution manufactured by CSL Behring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Condition: Interstitial Lung Diseases
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The
      lung scarring that occurs in ILD is often irreversible with only mitigating therapy available
      so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to
      investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment,
      lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After
      careful characterization, cultured cells will be injected directly into the lesion by
      fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by
      measuring the key clinical indicators.
    


Intervention name(s): Lung stem cells
Intervention type(s): Biological
Intervention description(s): Patients will receive clinical grade lung stem cells (LSCs)injected into lung via fiberoptic bronchoscopy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the second generation
      dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available
      commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4 mg capsule
      in healthy adult male subjects. Subjects in this study will receive either a single oral dose
      of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a
      single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL
      0.4 mg capsule followed by a 28-day washout period both in fed state. The study will enroll
      approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable
      subjects. The total duration of a subject's involvement in this study is anticipated to be
      approximately 12 weeks.
    


Intervention name(s): Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg; Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
Intervention type(s): Drug; Drug
Intervention description(s): Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fed condition.; Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fed condition
Intervention MeSH terms: Tamsulosin; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg; Tamsulosin; healthy subject; bioequivalence; GI198745; dutasteride; tamsulosin hydrochloride
Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients
Condition: Intestinal Pseudo-Obstruction; Fecal Microbiota Transplantation
MeSH terms: Intestinal Pseudo-Obstruction
Study type: Interventional

Summary: 
      Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that
      primarily affects the movement of the intestines, leading to symptoms that resemble a true
      bowel obstruction but without a physical blockage. This condition is characterized by
      impaired motility of the gastrointestinal tract, which can result in severe symptoms and
      complications. In previous studies, the investigator found that sequential microbiota
      transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building
      on this foundation, the current study further investigates the effects of sequential
      interventions involving intestinal cleansing, small intestine bacterial treatment, fecal
      microbiota transplantation, and nutritional therapy on the short-term and long-term clinical
      symptom improvement in patients. Additionally, the investigator aim to elucidate the changes
      in gut microbiota phenotypes before and after treatment.
    


Intervention name(s): sequential fecal microbiota transplant combined with small intestinal fluid transplant
Intervention type(s): Other
Intervention description(s): for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration.
      Therefore, many specialists have used hysteroscopy as their first-line of routine exam for
      infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy
      as one of the routine steps in the fertility workup program has become mandatory before the
      final diagnosis of unexplained infertility.
    

Detailed description: 
      Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment
      of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an
      initial test without a high degree of suspicion for pathology due to the need for anesthesia
      in an operating room setting. The basic infertility work-up has included a HSG to evaluate
      the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction
      of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy
      (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final
      procedure in selected infertile women.

      Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity.
      However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy
      in most studies.
    

Intervention name(s): office micro hysteroscopy
Intervention type(s): Diagnostic Test
Intervention description(s): One hundred women with unexplained infertility recruited for office micro hysteroscopic sessions. A rigid fiberoptic 2-mm, 0 and 30 degrees angled hysteroscopy along with an operative channel for grasping forceps or scissors were used for both diagnostic and operative indications. The findings, complications, and patient tolerance were recorded.
Intervention model: Single Group Assignment
Intervention model description: One hundred women with unexplained infertility recruited for office micro hysteroscopic session
Masking: None (Open Label)
Primary purpose: Diagnostic
Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
Condition: Gout, Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation
      study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of
      SAP-001 in Gout Patients with Hyperuricemia. The study will be single dose ascending cohorts
      across three doses with a placebo control arm.
    

Detailed description: 
      A total of 24 eligible adult subjects will be randomized in a 3:1 randomization ratio into
      two blinded treatment groups in the three dose cohorts with matching placebo arm. The
      duration of the observation would be 5 days for each subject with a single SAP-001 dosing to
      evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of
      oral SAP-001 (once daily) in adults gout patients with hyperuricemia.
    

Intervention name(s): SAP-001
Intervention type(s): Drug
Intervention description(s): SAP-001 or placebo treatment in a 3:1 randomization ratio.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose with placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Barbed Suture in Single-port Laparoscopic Myomectomy
Condition: Uterine Myoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to test our hypothesis that the use of unidirectional knotless
      barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine
      wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.
    

Detailed description: 
      The investigators plan to perform a multi-center randomized clinical trial on women scheduled
      for laparoscopic myomectomy. All women will get the same preoperative and postoperative care.
      Women will be assigned by chance to one of two groups: one group will receive single-port
      laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will
      receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control
      group). The investigators will collect information on suturing time and complications related
      to surgery.
    

Intervention name(s): Single-port laparoscopic myomectomy; Multi-port laparoscopic myomectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).; The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the use of etanercept as a replacement therapy for
      ciclosporin in patients with plaque psoriasis.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of etanercept as a
      replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who
      have achieved an adequate response with ciclosporin.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Etanercept 50 mg QW initiated during taper of ciclosporin; Randomized to placebo during taper of ciclosporin
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis
Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The
      apelin and its receptor, which is named apj, are expressed in many tissues including
      sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

      Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of
      investigation, demonstrating for the first time in mouse models that apelin exerts a
      glucose-regulating in vivo action. The investigators propose a translational clinical
      research project whose goal is to provide the proof of concept of the favorable influence of
      apelin on insulin sensitivity in humans.
    


Intervention name(s): Apelin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An apelin clamp in which an apelin infusion will be administered; A clamp reference during which a placebo solution (saline solution) will be administered
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Apelin; insulin; volunteers