bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Growth Hormone (GH) on Lipid Depots
Condition: Growth Hormone Deficiency
Study type: Interventional

Summary: 
      This study aims at investigating the effect of growth hormone on lipid-content of muscle and
      liver as well as visceral fat mass in relation to insulin sensitivity.

      In addition, hormonal regulation and free fatty availability is assessed during a physical
      exercise at 50-60% VO2max.

      Finally, the value of physical exercise in diagnosing growth hormone deficiency is
      investigated.

      Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise
      capacity and free fatty availability will influence these changes. 2)Growth hormone
      replacement therapy will predominantly reduce visceral fat mass and increase free fatty
      availability.

      3)Free fatty availability during exercise will be reduced in growth hormone deficient
      patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency
    

Detailed description: 
      Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral
      insulin sensitivity is assessed.

      Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass
      by MR-imaging.

      Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free
      fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical
      investigations are performed in adult growth hormone (GH) deficient patients before and after
      six months GH replacement therapy, in sedentary matched control subjects and in endurance
      trained athletes.
    

Intervention name(s): Growth hormone replacement therapy in growth hormone deficient patients only.
Intervention type(s): Drug
Intervention description(s): Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months
Other intervention name(s): Genotropin
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells
Condition: Melanoma; Neoplasm Metastasis
MeSH terms: Melanoma; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with
      Stage IV melanoma.
    

Detailed description: 
      A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology
      Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more
      efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further
      studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma
      cells from a melanoma cell line treated with heat before loading. Both studies have shown
      that DCs manufactured in this novel way were more efficient in priming the melanoma specific
      CD8+ cells. Thus, the strategy for this clinical trial will be to test recent laboratory
      findings in the clinical setting. An additional objective of the study will be to determine
      the effectiveness of a frozen vaccine product which differs from previous vaccines that were
      manufactured "fresh".

      This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV
      melanoma. The trial will accrue a total of 30 subjects. The primary goal of this trial will
      be to test the safety/tolerability/feasibility of the vaccine preparation and the rate of
      objective clinical response. A 15% objective response rate will be accepted in patients who
      have failed previous therapy with IL-2 and/or dacarbazine (DTIC) and/or temozolomide which
      are standard treatments for patients with malignant melanoma.

      Each subject will be given 7 initial injections in a fixed dose amount. The first 4 doses
      will be given at 2-week intervals (Weeks 0, 2, 4 and 6); the last 3 doses will be given at
      4-week intervals (Weeks 10, 14, and 18). Those patients who exhibit stable disease, partial
      response or complete response after 7 injections will be given 4 more vaccinations. Each of
      these additional 4 vaccinations will be given 3 months apart (Weeks 36, 48, 72 and 96). Scans
      and re-staging tests will be performed at scheduled intervals throughout the study.
    

Intervention name(s): Dendritic cell vaccination
Intervention type(s): Biological
Intervention description(s): Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic; Vaccine; Melanoma; Stage IV metastatic melanoma
Unilateral Massage as a Potential Treatment for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the
      left hemisphere. In this study a moderate pressure massage will be conducted by a trained
      professional on one of the following conditions: the right side of the body, the left side of
      the body, or both sides of the body (a traditional massage on the back of the body) while EEG
      measurements of brain activity are recorded and mood ratings are obtained.
    


Intervention name(s): Bi-lateral massage
Intervention type(s): Other
Intervention description(s): Unilateral massage on the left side of the body.
Other intervention name(s): Massage on the left side of the body.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unilateral Massage; Depression
Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome
Condition: Piriformis Syndrome
MeSH terms: Piriformis Muscle Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of hold relax agonist contraction and active
      release therapy on reducing pain intensity, improving functioning and sleep quality in
      patient with piriformis syndrome.

      Both these techniques are passive, non-invasive manual therapy techniques which are easy to
      perform and less time consuming and may yield better outcomes resulting improved quality of
      life.
    


Intervention name(s): Hold Relax with Agonist Contraction; Active Release Therapy
Intervention type(s): Other; Other
Intervention description(s): Participant will be in prone lying and heating pad will be applied on gluteal region for 10 to 15 minutes.
Passive sustained stretch to piriformis will be applied for 10 seconds.
The participant will be asked to actively contract the muscle for about 10 seconds (isometric contraction) and then relax.
Immediately after that participant is ask to again actively contract the muscle against therapist resistance for 6-10 seconds.
Ask the participant to relax while therapist will apply stretch the muscle to its new tissue tension barrier position and this position will be maintained for 30 seconds.
This maneuver is repeated for 3 to 4 repetitions, each starting from where the previous finished.; Specific muscle will be warmed up by applying heating pad for 10 to 15 minutes.
Patient will be positioned prone lying and the therapist will be standing at the side of affected limb.
Therapist will apply deep pressure at the area of tenderness while patient will actively move the limb from internal to external rotation repeatedly.
This maneuver will take about 15 minutes to complete in one session and will be applied alternatively 3 days a week for two weeks.
After this, cold pack is applied and general ROMs and strengthening exercises are performed to prevent soreness
Other intervention name(s): Proprioceptive Neuromuscular Facilitation Technique; Soft Tissue Mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Function, Pain,Hold Relax ,Sleep Quality, Mobilization
Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      We assessed the influence of time of administration of ACE inhibitors on circadian blood
      pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56
      days as first line treatment.
    

Detailed description: 
      Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure
      (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life
      and offer the advantage of a single daily dose, usually empirically taken in the morning.

      Objective: We assessed the influence of time of administration of ACE inhibitors on circadian
      BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

      Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with
      stage 1 of hypertension and naive to BP lowering medications, were included. They were
      randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or
      in the evening for 28 days, with crossover without washout period on day 29th and additional
      28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days
      28 and 56.
    

Intervention name(s): Perindopril Oral Tablet
Intervention type(s): Drug
Intervention description(s): Perindopril oral tablet morning versus evening
Other intervention name(s): Coversyl 10 mg
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Hypertension; Perindopril; chronobiology; Africa
Postoperative Cognitive Dysfunction in Heart Surgery
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Observational

Summary: 
      To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late
      postoperative periods by comparing the preop and postop period mini mental status tests in
      participants undergoing open heart surgery, and to compare the results of the investgators
      clinic with the world literature.
    

Detailed description: 
      Postoperative delirium (POD) and Cognitive Dysfunction (POCD) are changes in mental status,
      especially in the geriatric surgery population.Unlike other forms of delirium, POD results in
      early full recovery.Postoperative Cognitive Dysfunction (POCD) is more difficult to define
      and implies temporal consciousness impairment associated with surgery.

      While the diagnosis of delirium requires the detection of symptoms, the diagnosis of POCD
      requires preoperative neuropsychological testing and determining how much reduction will mean
      cognitive dysfunction. Postoperative delirium management is complex and requires multiple
      strategies. Methods of treating and preventing POCD are still uncertain.It is known that POCD
      is most commonly seen in patients undergoing open heart surgery.In this study, the
      investigators aim is to evaluate whether there is any change in cognitive status in the
      postoperative period compared to the preoperative period of participants who will undergo
      open heart surgery due to valve pathology or coronary stenosis.
    

Intervention name(s): Preoperative cognitive functions of participants undergoing open heart surgery; Postoperative cognitive functions of particiants undergoing open heart surgery
Intervention type(s): Other; Other
Intervention description(s): Surgery times and cross-clamping times of the participants who will undergo open heart surgery were recorded.; Changes in mini mental test scores were recorded in the postoperative period.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A study was planned on 140 patients undergoing open heart surgery.
      
Keywords: COGNITIVE DYSFUNCTİON; HEART SURGERY; POSTOPERATIVE DELIRIUM
Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
Condition: Post Partum Haemorrhage in Patients Undergoing Cesarean Section
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the effect of melatonin on pain and amount of blood
      loss after cesarean delivery one hundred twenty women with singleton term pregnancy
      undergoing elective or emergency lower segment cesarean section under spinal anesthesia were
      included in this study. The patients were randomly allocated to one of three groups of 40
      each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of
      anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated
      Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery
      of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic
      variables,will be recorded.Patients were instructed preoperatively in the use of the verbal
      rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If
      the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp
      100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS
      >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For
      determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and
      ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin
      values were determined both before surgery and 12 h following surgery
    


Intervention name(s): melatonin 3mg; melatonin 6mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To receive sublingual 3 mg melatonin before spinal of anesthesia .; To receive sublingual 6 mg melatonin before spinal of anesthesia .; To receive sublingual placebo tablet before spinal of anesthesia .
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Post partum haemorrhage; Cesarean; Pain
Canrenone as Add-on in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy on blood pressure reduction, safety and tolerability of two
      different dosages of canrenone as add-on therapy in patients already treated with Angiotensin
      Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics
      at the maximum dosage.
    

Detailed description: 
      To evaluate the efficacy on blood pressure reduction, safety and tolerability of two
      different dosages of canrenone as add-on therapy in patients already treated with Angiotensin
      Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics
      at the maximum dosage.

      In this multi-centre, phase IV, randomized, controlled, open-label, parallel groups trial,
      180 Caucasian patients affected by uncomplicated, essential hypertension, not well controlled
      by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage will be
      enrolled.

      At baseline patients will be randomized to canrenone, 50 mg, or canrenone 100 mg once a day,
      in addition to their current therapy, for three months.

      At the baseline, and after 3 months will be evaluated: systolic (SBP) and diastolic blood
      pressure (DBP), pulse pressure (PP), heart rate, fasting plasma glucose (FPG), homeostasis
      model assessment insulin (HOMA-index), total cholesterol, HDL-cholesterol, triglycerides,
      LDL-cholesterol, sodium, potassium, calcium, magnesium, uric acid, estimated glomerular
      filtration rate (eGFR), plasmatic urea, brain natriuretic peptide (BNP), aldosterone, and
      galectin-3.
    

Intervention name(s): Canrenone 50 vs canrenone 100 mg
Intervention type(s): Drug
Intervention MeSH terms: Canrenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
Condition: Raynaud's Phenomenon; Systemic Sclerosis
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      The effect of deep oscillation and biofeedback on Raynaud's phenomenon secondary to systemic
      sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was
      performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for
      four weeks or were randomized to the control group.
    


Intervention name(s): Biofeedback; Deep oscillation
Intervention type(s): Other; Other
Intervention description(s): Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.; Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Raynaud's phenomenon; biofeedback; deep oscillation; systemic sclerosis; physiotherapy
Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare two methods for neuromuscular monitoring,
      acceleromyography and mechanomyography for establishing the dose-response relationship and
      the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized
      that there would be no significant difference between potencies estimated using
      acceleromyography and mechanomyography.
    


Intervention name(s): TOF-Watch SX (Acceleromyography)
Intervention type(s): Device
Intervention description(s): Randomization of AMG to dominant or non-dominant arm. MMG at contralateral arm.
Allocation: Randomized
Masking: Single
Primary purpose: Treatment
Keywords: Acceleromyography; Mechanomyography; Neuromuscular block; Neuromuscular monitoring; Dose-response; Potency; Rocuronium
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl)
      buccal film in the treatment of dental pain.
    


Intervention name(s): Oxycodone; Buprenorphine; Placebo Film; Placebo Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single-dose of over-encapsulated oral 5-mg oxycodone capsule; Single-dose of buprenorphine HCl buccal film; Single-dose of placebo buccal film; Single-dose of oral placebo capsule
Other intervention name(s): Oxycodone capsule; BEMA Buprenorphine; BELBUCA; Buprenorphine HCl buccal film; Buprenorphine HCl buccal soluble film; Placebo; Placebo buccal film; BEMA placebo; Placebo; Oxycodone placebo
Intervention MeSH terms: Oxycodone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Deep Inhalation on Mannitol Responsiveness
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess how the inhalation technique used (deep inhalations versus tidal
      breathing) influences the results of a mannitol challenge test and a methacholine challenge
      test, if at all.
    

Detailed description: 
      This study will look at airway responsiveness to inhaled methacholine and mannitol
      administered with and without deep inhalation. This study will also investigate the role of
      airway inflammation on these responses, using sputum differential cell counts and fractional
      exhaled nitric oxide.

      This is a single center, open label, randomized study. Individuals with stable asthma will be
      eligible for enrollment. The study will consist of two parts, screening and testing.

      Part 1: Screening

      Participants will undergo consent procedures and assessments of fractional exhaled nitric
      oxide levels, airway responsiveness to methacholine and sputum induction. If participants
      show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be
      scheduled to undergo the testing part of the study.

      Part 2: Testing

      Participants will be randomized to undergo two methacholine or two mannitol challenges.
      Further randomization will occur with respect to whether the standard challenge method or the
      modified challenge method is performed first.
    

Intervention name(s): Deep inhalation technique; Tidal breathing technique; Methacholine; Mannitol
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Use of deep inhalations for administration of inhalant; Use of tidal breathing for administration of inhalant; Methacholine direct bronchoconstrictor used for bronchoprovocation challenge; Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Other intervention name(s): Provocholine; Aridol
Intervention MeSH terms: Mannitol; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mannitol; Methacholine; Deep inhalation; Tidal breathing