bioihbjkbjnl/mcl2 huggingface dataset:
CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care
Condition: Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Common mental illness, such as anxiety disorders and depression, is the main
      cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be
      effective in alleviating target symptoms of these disorders, but its effect on sick leave
      rates has not been sufficiently addressed. The investigators have developed an intervention
      called return to work (RTW), which is based in cognitive behavioral theory, that has a
      primary aim of helping sick-listed patients with common mental illness return to work. This
      new treatment has not been evaluated in a randomized controlled trial.

      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical
      common mental illness in a randomized controlled trial conducted in primary care.
      Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes
      are days of sick leave and clinician severity rating of psychiatric symptoms. This study
      could contribute to new knowledge regarding how to best treat patients on sick leave with
      mild common mental illness.
    


Intervention name(s): Cognitive behavior therapy; Return to work
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.; Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies
      by our group and others have shown that human recombinant growth hormone (GH) improves height
      velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive
      results have prompted us to ask further questions regarding GH use in CF including: a) Do
      patients with better baseline body weight and pulmonary function derive more benefit from
      treatment than those with worse weight and pulmonary function?, b) Does GH use improve the
      patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained?
      We hypothesize that GH treatment in CF patients will improve their clinical status and their
      quality of life. We further hypothesize that these effects will be present regardless of
      baseline body weight or pulmonary function, and that positive outcome will be sustained for
      at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit
      40 prepubertal children from five CF centers across the United States (8 per center).
      Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either
      the first or the second year. All subjects will be seen every three months. We will evaluate
      the following parameters every three months: 1) height, height velocity and Z-score, 2) body
      weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing
      DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak
      inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL
      forms specific for CF ("The Cystic Fibrosis Questionnaire"). After one year of study,
      subjects will "cross-over" to the other treatment arm. This 24 month study will allow us to
      statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple
      centers, and will allow us to assess sustained effect in the 20 subjects who receive GH
      during the first year, by comparing their results to results obtained during the year post
      treatment.
    


Intervention name(s): Human recombinant growth hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Primary purpose: Treatment
Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the
      relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed
      AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE
      (i.e. FLU alone in the MP29-02 vehicle; REF).

      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when
      administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product,
      Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE
      on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess
      adverse events.
    

Detailed description: 
      This study will enrol healthy subjects. It is considered that study results are more
      discriminative in healthy subjects than in rhinitis patients as there are no interferences by
      varying rhinitis symptoms and respective differences in the status of the nasal mucosa
      regarding the 3 study periods.

      The time schedule for serum sampling (pre-dose and 8, 15, 30, 45 min, 1, 1¼, 1½, 2, 2½, 3, 4,
      6, 8, 12, and 24 h p.a., time refer to the end of the second spray into the second nostril of
      each administration) is derived from previous bioavailability studies assuming a mean tmax of
      1 h p.a. [P5] and a mean t1/2 of 3 h [L9]. Sampling times are expected to cover an AUC0-tlast
      above 80% of the total AUC of fluticasone propionate (bioanalytical detection method with a
      LLOQ of 0.5 pg/mL).
    

Intervention name(s): Azelastine, Fluticasone; Fluticasone mono; Fluticasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray (= US formulation as used in pivotal studies); REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies); COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product)
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Evaluation of Porous Silica in Men
Condition: Safety Issues
Study type: Interventional

Summary: 
      The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of
      porous silica administered as a food additive can be used safely in normal weight and obese
      male humans, without significant side effects on gastrointestinal function, bowel emptying
      habits, and biomarkers.
    

Detailed description: 
      This single blinded safety study will consist of two study arms and include 10 males each
      (18-35 years). One arm will include participants with normal weight and one with obesity.
      After a placebo run-in period, all subjects will be given porous silica three times daily,
      with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study
      with highest dose for additional 10 weeks (Phase 2).

      The participants will have weekly contacts during with the representative for the study (PI
      or other research staff). Clinical examinations, and blood sampling will be performed day 1,
      7, 14, and 21. Faeces and morning urinary sampling day 1, and 21. Information regarding
      eating habits, sleep patterns, living conditions and gastrointestinal health were obtained
      from written forms and orally. If gastrointestinal adverse events would occur after increased
      dosage, the study staff will adapt the dosage protocol to facilitate adherence.
    

Intervention name(s): Porous silica; Placebo (microcrystalline cellulose)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The particle is rod shaped and approximately 1-3 x 0.4-0.5 micrometers with pore sizes in the range of 70-130 Ångström or 7-13 nanometer.; All participants starts with five days placebo run in period
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Alkaline Ionized Water: Sports Recovery and Inflammation Management
Condition: Sports Recovery
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether consumption of alkaline ionized water is
      effective for accelerating sports recovery.
    

Detailed description: 
      Alkaline ionized water versus tap water is consumed for one week prior to an exercise
      challenge, using a cross-over study design.
    

Intervention name(s): Alkaline ionized water; Tap water
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a 2 period one-day, double-masked, randomized, repeated measures,
      non-dispensing, cross-over study where the main purpose of this study is to compare the
      performance of a new daily disposable silicone hydrogel lens with that of an existing similar
      lens.
    


Intervention name(s): Test 8.5BC; Test 9.0BC; Control 8.5BC; Control 9.0BC
Intervention type(s): Device; Device; Device; Device
Intervention description(s): senofilcon A contact lenses with 8.5 base curve; senofilcon A contact lenses with 9.0 base curve; narafilcon A contact lenses with 8.5 base curve; narafilcon A contact lenses with 9.0 base curve
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Contra-lateral Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?
Condition: Food-drug Interaction
Study type: Interventional

Summary: 
      Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances
      shown to interact with a variety of medications. However, unanswered questions remain
      regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice
      interactions. Compounds in grapefruit juice called furanocoumarins have been established as
      major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs,
      leading to increased circulating drug concentrations. Increased drug concentrations can in
      turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown,
      paradoxically, to decrease circulating concentrations of some drugs, including the
      non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible
      metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine
      concentrations is unknown. The purpose of the proposed study is to compare the effects of a
      "furanocoumarin-free" grapefruit juice with grapefruit juice on circulating concentrations of
      fexofenadine.
    

Detailed description: 
      Participants: Healthy volunteers of any race/ethnicity, ranging in age from 18 to 65 years,
      will be enrolled.

      Procedures (methods): Procedures will include administration of water, furanocoumarin-free
      grapefruit juice, or grapefruit juice with fexofenadine; placement of an intravenous (IV)
      line; and collection of blood over 72 hours.
    

Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention description(s): This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice, or furanocoumarin-free grapefruit juice.
Other intervention name(s): Screening: labs, physical exam; Placement of an intravenous (IV) line; Collection of blood over 72 hours
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Repeated Subcutaneous Administration of ABvac40 in Mild to Moderate Alzheimer's Disease Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This first time study in humans was designed to assess tolerability and safety of repeated
      subcutaneous injections of ABvac40, an active immunization against the C-terminal end of
      Abeta1-40.
    


Intervention name(s): ABvac40; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus
      placebo control on the transition to overt nephropathy in patients with diabetic nephropathy
      manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy
      and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan,
      Telmisartan) for diabetic nephropathy patients.
    

Detailed description: 
      A prospective, randomised, double-blind, multicentric and comparative study to investigate,
      on a long-term basis, the preventive effect on the transition to overt nephropathy and the
      safety of Telmisartan (Micardis) against placebo in patients with diabetic nephropathy,
      manifesting microalbuminuria associated with type II diabetes.

      Study Hypothesis:

      The hypothesis is that Telmisartan (Micardis) at 40 mg or 80 mg versus placebo control in
      patients with concurrent type II diabetic mellitus or diabetic nephropathy demonstrating
      microalbuminuria, has the preventive effect on transition from incipient to overt
      nephropathy.

      Comparison(s):

      The primary endpoint is defined as the transition from incipient to overt nephropathy, and
      the non-transition curve will be demonstrated based on the Kaplan-Meier method. The
      evaluation criteria for the point to transition to overt nephropathy is defined as urinary
      albumin to creatinine ratios at consecutive 2 measuring points increasing over 300
      mg/g-Creatinine and excess 30% increase comparing with the baseline value. The curve of
      non-transition will be compared with Logrank test. Those in BIBR277 groups are sequentially
      compared with that in the placebo group by the closed testing procedure.
    

Intervention name(s): Telmisartan capsule 40 mg; Placebo; Telmisartan capsule 80 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma
Condition: Hilar Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma; Klatskin Tumor
Study type: Observational

Summary: 
      Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for
      staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with
      biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with
      reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet
      estimated. The objective of the study was estimation of the short-term results of
      split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the
      first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA)
      cholangiocarcinoma compared with portal vein embolization (PVE).
    

Detailed description: 
      ALPPS has been recently proposed as the most effective method to induce marked and rapid
      hypertrophy of FLR with 95-100% completion rate of the second stage. The most common
      indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory
      immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality
      reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be
      treated by ALPPS.

      Recently reported modifications of in situ splitting (partial ALPPS, RALPPS
      (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy)
      and ALTPS (associating liver tourniquet and right portal vein ligation for staged
      hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby
      reducing postoperative morbidity.

      The other important idea was to preserve all initial benefits of ALPPS in terms of liver
      hypertrophy and completeness of the second stage. To date, there is no evidence of the
      benefits of any new ALPPS modification over others in reducing the morbidity of procedure,
      particularly in patients with CCA..
    

Intervention name(s): RALPPS; portal vein embolization + major liver resection
Intervention type(s): Procedure; Procedure
Intervention description(s): RALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage; PVE on the first stage and major liver resection on the second stage
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients refered to the Center from other hospitals and primary care clinics
      
Keywords: ALPPS; RALPPS; Portal Vein Embolization; Hilar Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 2

Summary: 
      In heavy marijuana smokers, opioid receptor blockade increases the subjective and
      cardiovascular effects of marijuana. The current study was designed to clarify
      opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function
      for marijuana-elicited effects in heavy marijuana smokers. For this within-subject,
      double-blind study, a marijuana smoking procedure was designed to characterize a
      dose-response relationship for marijuana's subjective and cardiovascular effects under
      blinded conditions.
    


Intervention name(s): Inactive Marijuana (0% THC); Active Marijuana (5.5% THC); Active Marijuana (6.2% THC); Naltrexone; Placebo naltrexone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Marijuana cigarette containing 0% THC; Marijuana cigarette containing 5.5% THC; Marijuana cigarette containing 6.2% THC; Naltrexone (12mg/70kg); Naltrexone (0mg)
Other intervention name(s): Cannabis; Cannabis; Cannabis; Revia; PBO
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: naltrexone; smoked marijuana; marijuana use
Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      We want to investigate if early follicular phase downregulation and androgen priming, by use
      of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs
      of improvement compared to standard short antagonist protocol
    


Intervention name(s): Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH
Intervention type(s): Drug
Intervention MeSH terms: Androgens; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intraarticular Distal Radius Fractures, X-fix or Volar Fixation
Condition: Dorsally Displaced Intraarticular Distal Radius Fractures; Age 50 - 74 for Females or 60-74 for Males; Low Energy Trauma
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Distal radius fractures are treated surgically if severely displaced. This study aims to
      investigate the outcome after surgery. The investigators will randomize patients to either
      external fixation with optional addition of k-wires or open reduction and fixation with a
      volar plate.
    

Detailed description: 
      This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish
      National board on Ethical Permits
    

Intervention name(s): External fixation; Volar plate
Intervention type(s): Procedure; Procedure
Intervention description(s): Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s); Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.
Other intervention name(s): Stryker's Hoffman external fixation; Synthes Two Column Plate (TCP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radius; fracture; wrist; external; fixation; volar; plate; DASH; PRWE