bioihbjkbjnl/mcl2 huggingface dataset:
Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia
Condition: Morbidity; Mortality; Complications; Function
Study type: Interventional

Summary: 
      Total knee replacement is very common in Germany. After surgery patients have severe pain in
      the knee; initiation of the physiotherapy, however, is important in the first three days
      after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are
      commonly used after surgery. Both methods are used in Germany. Both methods have advantages
      and disadvantages. We wanted to answer the question which method of analgesia - after total
      knee replacement - is better concerning complications and function (after 3 months) ?
    


Intervention name(s): Femoral catheter; Epidural catheter
Intervention type(s): Device; Device
Intervention description(s): Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.; The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: epidural anesthesia; femoral block; patient control analgesia
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the
      GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study
      entry.
    


Intervention name(s): Pneumococcal vaccine GSK2830930A; Synflorix™
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose administered intramuscularly; 1 dose administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenzae; Safety; Pneumococcal vaccine; Streptococcus pneumoniae; Immunogenicity; Toddlers
Phase 1 Study of LQT-1213 in Healthy Adults
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled study to be conducted
      in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple
      ascending dose (MAD). Potential participants for each part will undergo screening procedures
      within 28 days of enrollment.
    


Intervention name(s): LQT-1213; Placebo
Intervention type(s): Drug; Other
Intervention description(s): LQT-1213 is a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor; Matching Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: LQT-1213; Congenital Long QT Syndrome; LQTS; Serum glucocorticoid regulated kinase-1; SGK-1 inhibitor
Immediate Impact of Lumbar Fascia Stretching on Hamstring Flexibility
Condition: Hamstring Injury
Study type: Interventional

Summary: 
      Introduction: the hamstring muscles has a great tendency to decrease its extensibility,
      originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in
      addition to other problems on adjacent structures. All this present a great socioeconomic
      impact in the investigator's society. Various techniques have been demostrated to prduce an
      increase in flexibility, among which are the fascial techniques.

      Objective: to evaluate the immediate efficacy of the treatment of the lumbar fascia in the
      flexibility of the hamstring musculature.

      Methods: 41 women between 18 and 39 years old, in two groups. The experimental group received
      a technique of fascial stretching in the lumbar area while the control group participated in
      an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by
      the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).
    

Detailed description: 
      The hamstring muscles has a great tendency to decrease its extensibility, originating a
      pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to
      other problems on adjacent structures. This study aims to help improve treatment for the
      problem mentioned before, which can be included within a therapeutic framework to combat SHS.
      In recent years, investigations have been carried out that include different techniques for
      stretching the hamstring muscles, as well as the treatment of other structures belonging to
      the posterior superficial chain. Within this last section, myofascial stretching techniques
      have been shown to be effective both in the short and medium term. Different techniques for
      stretching the hamstring muscles have been carried out with the aim of increasing the
      flexibility of the lower back in general.

      he objective is to evaluate the immediate efficacy of the treatment of the lumbar fascia in
      the flexibility of the hamstring musculature.

      The participants are 41 women between 18 and 39 years old, in two groups. The experimental
      group received a technique of fascial stretching in the lumbar area while the control group
      participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs
      was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test
      (PKE).
    

Intervention name(s): Treatment of the lumbar fasciae; Placebo intervention
Intervention type(s): Other; Other
Intervention description(s): Treat the lumbar facial with a manual technique; Introduce in a machine off
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hamstring muscles; lumbar fascia; flexibility
Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis
Condition: Cicatricial Trichiasis
MeSH terms: Trichiasis
Study type: Interventional

Summary: 
      in recent years there has been a significant shift from this destructive procedure to a
      reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal
      Rotation (BLTR).
    


Intervention name(s): Anterior Lamellar Recession; Bilamellar Tarsal Rotation
Intervention type(s): Procedure; Procedure
Intervention description(s): ALR is a common surgical treatment that splits the skin and orbicularis oculi muscle from the tarsus and conjunctiva to recede the anterior lamella and expose the tarsus. Interlamellar separation can be accomplished via a grey line technique, an eyelid crease approach, or a combination of the two; the full-thickness transverse blepharotomy combined with everting sutures to rotate the inferior portion of the upper lid outwards and this procedure has a low recurrence risk
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability
Condition: Beliefs; Disability Physical
Study type: Interventional

Summary: 
      This trial aims at comparing the effectiveness of different didactic tools developed for
      patients with chronic pain to correct misbeliefs and improve disability in patients with
      chronic low back pain
    

Detailed description: 
      This trial aims at comparing the effectiveness of different didactic tools (an educational
      website vs a booklet) developed for patients with chronic pain to correct misbeliefs and
      improve disability in patients with chronic low back pain.

      Participants of the 2 experimental groups will be invited to use the tool they receive during
      a one-month period.
    

Intervention name(s): Retrain pain educational website; Booklet
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will be invited to consult an educational website developped for patients with chronic pain; Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF,
      blood flow in the middle cerebral artery and diameter of superficial temporal artery and
      correlate that to known pathophysiology of headache to see if PGE2 is involved in headache
      pathophysiology.
    


Intervention name(s): PGE2
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
Condition: Immune (Idiopathic) Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the
      treatment of immune thrombocytopenic purpura.
    

Detailed description: 
      To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients
      diagnosed with immune thrombocytopenic purpura with respect to:

        1. Increase of platelet count ≥ 50x10^9/L (primary objective).

        2. Time taken for the platelet count to reach ≥ 50x10^9/L.

        3. The length of time the platelet count remains ≥ 50x10^9/L.

        4. The maximum platelet level.

        5. Regression of bleeding episodes during the first 10 or 14 days.

      To determine if IGIV3I Grifols 10% is safe with respect to:

      Nature, severity and frequency of adverse reactions during and after infusions by percentage
      of subjects and percentage of infusions.
    

Intervention name(s): IGIV3I Grifols
Intervention type(s): Biological
Intervention description(s): Immune Globulin Intravenous (Human)
Other intervention name(s): IGIV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study compared an in-home asthma management program provided by nurses or respiratory
      therapists to see if those receiving program had fewer hospitalizations, clinic and emergency
      room visits and higher levels of satisfaction and health related quality of life.
    

Detailed description: 
      Background: Disease management may improve outcomes and reduce cost. We compared an in-home
      asthma management program (AMP) delivered by respiratory therapists (RTs) or nurses (RNs) to
      standard care (SC) in 159 adults with moderate to severe asthma to determine the effect on
      health care utilization (HCU), patient satisfaction (PS) and health related quality of life
      (HRQOL).

      Methods: This single center, prospective trial randomized subjects, age 18-64, to three
      groups: SC, AMP-RT or AMP-RN. Outcomes at six-months were HCU, cost, pulmonary function,
      symptoms, environmental assessment, asthma self-management, HRQOL (SF-36; St. Georges
      Respiratory Questionnaire [SGRQ]) and PS. Frequencies were compared using chi 2; all other
      variables were compared using ANOVA with a post-hoc test.
    

Intervention name(s): In-home asthma management program (AMP) provided by nurses; In-home asthma management program (AMP) provided by respiratory therapists
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.); The AMP included asthma education (medications use, monitoring, triggers, steps to manage asthma attacks), demonstration and training (peak flow meter use, MDI and nebulizer use, asthma diary), home environment assessment and suggestions for environmental changes (mattress covers, control of dust, pets, fumes, cleaning materials, cock roach control, etc.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Asthma management; cost; disease management; respiratory care; nursing; health care utilization; health related quality of life
Prostate Biopsy Access Needle & Needle Guide Feasibility Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The objective of the study is to assess the design features of a modified stainless steel
      access needle (single use disposable) in a clinical setting and a disposable, single use,
      custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The
      disposable stainless steel access needle may be used with or without the disposable needle
      guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary
      purpose of the single-use disposable access needle is to guide the use of a biopsy gun to
      obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of
      the perineum. The primary purpose of the disposable needle guide is to stabilize the needle
      biopsy and better approximate the most direct path to the prostate.
    

Detailed description: 
      The objective of the study is to assess the design features of a modified stainless steel
      access needle (single use disposable) in a clinical setting with and a disposable, single
      use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe.
      The disposable stainless steel access needle may be used with or without the disposable
      needle guide, but will always be used with ultrasound image guidance and a biopsy gun. The
      primary purpose of the single-use disposable access needle is to guide the use of a biopsy
      gun to obtain a tissue sample from the patient's prostate gland through a percutaneous
      puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize
      the needle biopsy and better approximate the most direct path to the prostate. For some
      subjects, the study will assess the fit and functionality of the stainless steel access
      needle when used in conjunction with the disposable needle guide as well as multiple handling
      aspects of the access needle and disposable needle guide when utilized in a prostate biopsy
      procedure. The study will also assess the ability of trans-rectal ultrasound to appropriately
      image the stainless steel access needle and biopsy gun needle at, near, and within the
      prostate tissue.
    

Intervention name(s): Access needle
Intervention type(s): Procedure
Intervention description(s): The primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Transperineal; Transrectal; Needle Guide; Biopsy
Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3%
      of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as
      obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only
      medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with
      SRI treatment, most patients continue to experience significant OCD symptoms, impaired
      functioning, and diminished quality of life. Recent evidence suggest that a different
      neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target
      glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from
      OCD. In this study the investigators are recruiting patients to receive the drug memantine,
      which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD
      medications they are taking.

      Open label memantine will be titrated in 5mg increments weekly to target dose of 10mg po bid
      for up to 6 weeks. Memantine will be continued to 12 weeks in those with treatment
      response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV
      ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks
      of memantine).
    

Detailed description: 
      see above
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD
Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Human experimental pain models are useful in understanding the mechanisms underlying clinical
      pain conditions and can be used to test the analgesic efficacy of drugs used in the
      management of pain. Once established these models can be used as mechanism biomarkers in
      early development clinical studies to establish proof of mechanism for novel compounds. The
      cold pain model is a mechanistic pain biomarker with potential application in proof of
      mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research
      Unit and demonstrate we can effectively screen subjects for this model and examine the effect
      of morphine, diphenhydramine, and gabapentin in the cold pain model.
    

Detailed description: 
      Cold pain methodology development
    

Intervention name(s): Gabapentin; Diphenhydramine; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule, single 1200mg dose; Tablet, single 50mg dose; IV, single 10mg dose; Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
Intervention MeSH terms: Diphenhydramine; Promethazine; Morphine; Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Cold pain methodology; Healthy male volunteers; gabapentin; Diphenhydramine; morphine
Evaluation of a Preoperative Education in Total Knee Arthroplasty
Condition: Knee Osteoarthritis (Knee OA)
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted
      education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there
      is lack of validated booklet containing evidence based informations.

      Our aim is to assess the impact of an evidence based education pre-operative booklet on
      patient's knowledge and beliefs. The secondary objectives are to assess the impact of the
      booklet on patient's satisfaction on the information received, the length of stay in
      orthopedic surgery and the transfer rate to rehabilitation wards.

      To show a difference of 2 points on the knowledge score (range 0-10) between the two groups,
      with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations
      will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and
      beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data
      will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher
      exact test.

      The study protocol was approved by the local Ethic Committee.
    

Detailed description: 
      The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted
      education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there
      is lack of validated booklet containing evidence based informations.

      Our aim is to assess the impact of an evidence based education pre-operative booklet on
      patient's knowledge and beliefs. The secondary objectives are to assess the impact of the
      booklet on patient's satisfaction on the information received, the length of stay in
      orthopedic surgery and the transfer rate to rehabilitation wards.

      To show a difference of 2 points on the knowledge score (range 0-10) between the two groups,
      with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations
      will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and
      beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data
      will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher
      exact test.

      The study protocol was approved by the local Ethic Committee.
    

Intervention name(s): Kruskal-Wallis and qualitative parameters
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: • Knee osteoarthritis; Total knee arthroplasty; Selfcare; Booklet; Rehabilitation