bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Follow-up After ACL Reconstruction
Condition: Deficiency of Anterior Cruciate Ligament; Injury of Anterior Cruciate Ligament
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      No former studies have done long-term evaluation on patients reconstructed with hamstrings
      graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel.
      The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum
      of 10 years after surgery. According to former published studies on alike methods, the use of
      transtibial drilling of the femoral graft tunnel causes an increased rotational instability
      of the knee. The investigators aim to map the clinical stability of this group as well as
      evaluating the general outcome at the long-time horizon.
    

Detailed description: 
      Patients will be invited to a clinical follow-up with x-ray of the knee, scoring of Lysholm
      and IKDC subjective scores, clinical examination including instrumented testing with a
      KT-1000. After informed consent data will be collected from patient records and stored in a
      secured internal database. Analysis will be done with the SPSS package.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients reconstructed with Howells guide, hamstrings graft and transtibial drilling at
        Haraldsplass Deaconess Hospital from 1999 to 2001.
Effect of Secretin in Functional Dyspepsia and Healthy Subjects
Condition: Dyspepsia; Healthy
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Insights into the pathophysiology of functional dyspepsia, with recent demonstration of
      inflammation with eosinophilia and mastocytosis in the duodenum (3, 6, 7), providing a
      possible lead toward reduced secretion of a potential mediator of post-prandial gastric
      accommodation, the gastrointestinal peptide hormone secretin. The dominant site of synthesis
      and secretion of this hormone are enteroendocrine S cells in the duodenum.
      Inflammation-induced damage to these cells could produce a deficiency. Since intraluminal
      acid is a prominent stimulant of S cell secretion, the attempts to treat functional dyspepsia
      with anti-secretory medications could actually exacerbate a secretin deficiency syndrome.
      This raises the possibility of the therapeutic use of a secretin agonist or a positive
      allosteric modulator of the secretin receptor for patients with functional dyspepsia.
    

Detailed description: 
      The investigators will utilize single photon emission computed tomography (SPECT) methodology
      and gamma scintigraphy present in the GI laboratory of the outpatient Clinical Research Unit
      to study fasting gastric volumes and postprandial gastric accommodation responses and gastric
      emptying rates of a standardized meal in patients with functional dyspepsia and healthy
      subjects. Both groups will be studied twice, using crossover design, once with administration
      of secretin and once with placebo.
    

Intervention name(s): Human Secretin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injected once over one minute; Injected once over one minute
Other intervention name(s): ChiRhoStim; Normal Saline
Intervention MeSH terms: Secretin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Outcomes of Delivery in Patients With Dyspareunia
Condition: Dyspareunia; Pregnancy; Provoked Vestibulodynia; Pelvic Floor Dysfunction
MeSH terms: Dyspareunia; Vulvodynia; Vulvar Vestibulitis
Study type: Observational

Summary: 
      The focus of this pilot study is to determine if a woman who experiences pain during sexual
      intercourse has a higher risk of complications during labor and delivery secondary to pelvic
      floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is
      unclear whether women with prepartum dyspareunia experience an improvement following vaginal
      delivery. While physicians may expect that vaginal birth improves dyspareunia due to the
      stretching effect on pelvic floor, to date, there is insufficient evidence to support this
      claim. The Investigators plan to prospectively study 200 patients at our Institution, collect
      information regarding birth and follow them, via questionnaires, regarding their dyspareunia
      postpartum.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical
        Center, above the age of 18
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the reciprocal control between gastric functions
      and intestinal parameters in the development of satiation in obese people.
    

Detailed description: 
      Obesity has reached pandemic proportions, obesity-associated complications are extensive and
      the current treatment options are limited. These facts demonstrate the need for an improved
      understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element
      in the control of satiation; discrepancies exist, however, for the role of gastric and
      intestinal parameters in the control of satiation in relation to body mass. To achieve a
      comprehensive understanding for the reciprocal control between gastric functions and
      intestinal parameters in the development of satiation in obese people the investigators will
      compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1),
      peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy
      volunteers.

      Time needed to reach the level of satiation and total calorie intake will be measured by a
      standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath
      test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient
      drink.
    

Intervention name(s): ensure plus; standardized test meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL; scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glucagon-like peptide-1; peptide tyrosine tyrosine; ghrelin; stomach; small intestine; gastric emptying
A Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
Condition: Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
MeSH terms: Facies
Study type: Interventional

Summary: 
      20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation
      treatment, meet all the inclusion and none of the exclusion criteria, and have signed a
      written informed consent, will be enrolled. Subjects will be divided randomly into two
      treatment groups:

        1. Group A: subjects will use a basic skin care regime following a full facial rejuvenation
           with hyaluronic acid soft-tissue filler and botulinum neurotoxin.

        2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with
           hyaluronic acid soft-tissue filler and botulinum neurotoxin.

      The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit
      2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation
      (Visit 5).

      Changes in the subjects' quality of skin will be determined by the PI's assessment of skin
      tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as
      well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and
      hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.

      Subjects' satisfaction with treatments and their quality of skin will be determined through a
      self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The
      impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks
      following the treatments.
    


Intervention name(s): NuDerm® System; Placebo
Intervention type(s): Other; Other
Intervention description(s): The Nu-Derm® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation.; Basic skin care regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate if clazosentan (on top of normal routine medical care) can reduce
      the risk of developing complications related to cerebral vasospasm and permanent brain damage
      as compared to normal routine medical care alone.
    

Detailed description: 
      When a blood vessel just outside the brain bursts and causes bleeding onto its surface, the
      space surrounding the brain (the subarachnoid space) fills with blood. This condition is
      called subarachnoid hemorrhage. The bleeding due to the rupture of a pouch-like structure or
      a bulge (called an aneurysm) that formed on one of the blood vessels is condition called
      aneurysmal subarachnoid hemorrhage (aSAH).

      In this study, clazosentan is being tested against normal routine medical care to determine
      if clazosentan can reduce the risk of developing complications related to vasospasm and
      permanent brain damage.

      Participation will last for approximately 6 months from the episode of bleeding. For subjects
      randomized in the high-risk prevention group, treatment will start within 96 hours following
      the time of the aneurysm rupture, and be administered where possible, for 14 days. For
      subjects randomized in the early treatment group, treatment must begin within 24 hours of the
      time of the angiogram documenting the cerebral vasospasm necessary for entry into the study.
      Treatment will be administered for a minimum of 6 days and a maximum of 14 days. Recruitment
      in the early treatment group has been discontinued.

      The end-of-study will be conducted as a telephone interview 6 months after the episode of
      bleeding.
    

Intervention name(s): Clazosentan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.; Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.
Other intervention name(s): ACT-108475
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of MD1003 in Amyotrophic Lateral Sclerosis
Condition: ALS; Amyotrophic Lateral Sclerosis; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms
      (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during
      which all patients will receive biotin 300 mg/day.
    


Intervention name(s): MD1003; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): capsules 100mg 3 times per day; capsules 100mg lactose 3 times per day
Other intervention name(s): BIOTIN
Intervention MeSH terms: Biotin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The primary objective of the study is to evaluate the safety of biotin at 300 mg/day over placebo in patients with amyotrophic lateral sclerosis.
This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during which all patients will receive biotin 300 mg/day.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Biotin; MD1003; ALSFRS-R
Sarcopenia and Diabetes Mellitus
Condition: Sarcopenia
MeSH terms: Sarcopenia; Diabetes Mellitus
Study type: Observational

Summary: 
      The association of diabetes mellitus type 2 (T2DM) with sarcopenia has not been adequately
      investigated. Sarcopenia is characterized by progressive and generalized loss of skeletal
      muscle mass which may affect performance.
    

Detailed description: 
      The relationship between DM and sarcopenia has not been extensively investigated. Skeletal
      muscle is the primary site of glucose deposition, and decreased muscle mass plays a role in
      impaired glucose metabolism in patients with insulin resistance and type 2 diabetes. Skeletal
      muscle resistance to insulin action appears to be the link between type 2 diabetes (T2DM) and
      sarcopenia. Hyperglycemia is a metabolic dysfunction which can potentially damage muscle
      cells. Insulin deficiency leads to marked muscle catabolism that can be reversed by exogenous
      insulin administration.

      The metabolic disorder in diabetics may be reversible.Thus, it may be possible to restore
      physical ability by restoring the musculoskeletal system.Therefore, the diagnosis of
      sarcopenia if made can lead to interventions which may prevent the deterioration of body
      composition and the subsequent deterioration of quality of life. According to the results of
      the aforementioned studies it is still inconclusive if the metabolic disorder in diabetes may
      be related to sarcopenia, or sarcopenia may be a consequence of diabetes.
    

Intervention name(s): WHOLE BODY DXA
Intervention type(s): Radiation
Intervention description(s): Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A group of 36 patients, aged 20-80 years old, 18 male and 17 female with type 2 diabetes
        mellitus, and a control group with the same demographic characteristics, participated in
        the study. All were previously examined by an endocrinologist (in a public hospital,
        private or university outpatient clinic) from March to July 2018. The control group
        consisted of 14 community people who visited the endocrinology outpatient hospital clinic
        for a routine checkup, or with a non-related to diabetes disease.
      
Keywords: sarcopenia; diabetes mellitus; skeletal muscle index
Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy
Condition: COPD
Study type: Observational

Summary: 
      This is a prospective non-interventional trial to measure the health related quality of life
      of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple
      therapy (Trimbow®) and characterisation of determinants of treatment adherence.
    

Detailed description: 
      The primary goal of COPD therapy is the prevention of exacerbations and clinical
      deterioration. To achieve these goals, treatment adherence (i.e. taking medication as
      prescribed) is important. However, non-adherence (not taking medication as prescribed) is
      common in COPD and can be affected by lifestyle changes or use of multiple inhalers.

      The effects of Trimbow® on patients' health related quality of life, adherence and clinical
      outcomes have not been assessed in a UK real-world setting. This non-interventional trial
      aims to collect data from COPD patients under routine care over a 6 month period, for whom
      their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to
      investigate any changes in quality of life, as well as changes in lung function and the need
      for any additional therapy over 6 months. We also plan to investigate the adherence or
      reasons for non-adherence to Trimbow® as used in everyday routine.
    

Intervention name(s): Non-interventional
Intervention type(s): Other
Intervention description(s): As this is a Non-interventional trial, only data obtained within the current routine management of COPD at outpatient respiratory centres or GP centres will be documented.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will only be included in the Non-Interventional Trial if Trimbow® has been
        prescribed in line with its current marketing authorisation and the guidance specified in
        the summary of product characteristics (SmPC).

        Physicians are urged to offer enrolment to all of their eligible patients consecutively as
        they present for their routine visit, and not select patients from their patient database.

        Eligible patients may only be included in the NIT after providing written (witnessed, where
        required by law or regulation), IEC-approved informed consent, or, if incapable of doing
        so, after such consent has been provided by a legally acceptable representative of the
        patient.
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial
Condition: Postpartum Period
Study type: Interventional

Summary: 
      In order to determine the timing of LNG-IUS insertion that results in a greater proportion of
      women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial
      of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks
      gestation and greater. At the time of vaginal delivery, women will be randomized to receive
      either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks
      post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to
      confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number
      of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the
      safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms
      experienced by participants. This is a sub-study of the Contraceptive Choice Project, a
      prospective cohort study that aims to improve the use of long-acting contraception by
      removing financial barriers which has already enrolled over 5,000 patients. Association of
      this study with CHOICE offers unique advantages including infrastructure to support subject
      recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS
      devices.

      We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS
      immediately after placenta delivery will have higher rates of LNG-IUS continuation due to
      poor rates of follow up in the interval insertion group. This is likely to be particularly
      noticeable in our patient population, which is largely uninsured with poor access to
      healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping,
      which may be disguised by the post-partum period. Published reports of immediate
      post-placenta insertion focus on expulsion rates and do not report on symptoms and
      satisfaction rates.
    


Intervention name(s): Post-Placenta Mirena Insertion; Interval Insertion
Intervention type(s): Device; Device
Intervention description(s): Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta; Insertion of Mirena 4-8 weeks post partum after vaginal delivery
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Postnatal care
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Africa and Middle East. The objective of the study is to compare
      glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30
      twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in
      subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.
    


Intervention name(s): biphasic insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment