bioihbjkbjnl/mcl2 huggingface dataset:
Neuropsychological Rehabilitation of Spontaneous Confabulation
Condition: Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      Confabulators consistently generate false memories without intention to deceive and with
      great feeling of rightness. However, there is currently no known effective treatment for
      them. In order to fill this gap, the aim of this trial was to design a neuropsychological
      treatment based on the current theoretical models and test it experimentally in two groups of
      confabulators: experimental vs. control. The treatment consisted of some brief material that
      patients had to learn and recall at both immediate and delayed moments. After both
      recollections, patients were given feedback about their performance (errors and correct
      responses). Pre-treatment and post-treatment baselines were administered. Confabulators in
      the control group performed the baselines without treatment, and were then offered the
      treatment after the second baseline.
    


Intervention name(s): Neuropsychological treatment
Intervention type(s): Behavioral
Intervention description(s): Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
Other intervention name(s): Confabulations treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Confabulations; Neuropsychological rehabilitation; Memory
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study
      is designed to test the safety and the extent of the GW679769 affect on dexamethasone and
      ondansetron levels in humans.
    


Intervention name(s): Casopitant (GW679769) Oral Tablets; dexamethasone; ondansetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.; Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.; Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
Other intervention name(s): GW679769 Oral Tablets; dexamethasone oral tablets & intravenous; ondansetron oral tablets & intravenous
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Casopitant; BB 1101
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GW679769,; Casopitant,; Dexamethasone,; Healthy Human Volunteer; Ondansetron,
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety,
      tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in
      participants with postmenopausal osteoporosis, in a comparative manner.
    

Detailed description: 
      This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group
      study that includes 2 periods as:

        1. Main period (52 weeks), consists of Treatment Period 1 (26 weeks) and Treatment Period 2
           (26 weeks). On Day 1 of Treatment Period 1, prior to dosing, participants will be
           randomized in a 1:1 ratio to receive either RGB-14-P or Prolia®.

        2. Transition Period: consists of Treatment Period 3 (26 weeks). On Day 1 of Treatment
           Period 3 (Week 52), a subset of participants who received Prolia® during the Main Period
           will be re-randomized 1:1 to receive either a dose RGB-14-P or Prolia® in a
           double-blinded manner. A subset of participants continuing in the Transition Period who
           received RGB-14-P during the Main Period will continue to receive a dose of RGB-14- P
           but will also follow the randomization procedure to maintain blinding.

      All participants will receive the study drugs on 2 occasions (Weeks 0 and 26), on Day 1 of
      Treatment Periods 1 and 2. Participants continuing to the Transition Period will receive the
      study drugs on a third-occasion (Week 52), Day 1 of Treatment Period 3. One Treatment Period
      will take 6 months (26 weeks, 183 days).
    

Intervention name(s): RGB-14-P; Prolia®
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.; Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Biosimilars; Prolia®
Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease; Emphysema; Pulmonary Rehabilitation
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional

Summary: 
      Regular physical activity has been found to be important in maintaining health and well-being
      in people with COPD. The purpose of this study is to test new technology and health coaching
      aimed to help people with COPD become more physically active in their daily lives.
    

Detailed description: 
      This study consists of a home-based pulmonary rehabilitation system. The system consists of a
      tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls.
      The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A
      will complete the study activities during the first 8 weeks of the study followed by a period
      of observation. Group B will complete 8 weeks of observation followed by 8 weeks of
      rehabilitation.
    

Intervention name(s): Home-base Pulmonary Rehab with Health Coaching
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
Condition: Immunologic Diseases; Autoimmune Diseases; Systemic Lupus Erythematosus; Lupus Nephritis; Lupus Glomerulonephritis
MeSH terms: Nephritis; Lupus Nephritis; Glomerulonephritis; Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and
      effective in delaying and reducing renal flares in patients with lupus nephritis.
    

Detailed description: 
      LJP 394 (abetimus sodium) is a unique drug that is specifically designed to lower production
      of antibodies to double-stranded DNA. These antibodies are believed to contribute to kidney
      damage in patients with Systemic Lupus Erythematosus (SLE). Rising levels of these antibodies
      seem to be associated with exacerbations of kidney disease that are known as "renal flares."
      Currently, anti-inflammatory and cytotoxic drugs are used to treat renal flares.
      Unfortunately, these drugs are often associated with certain unpleasant side effects. The
      purpose of this trial is to determine whether LJP 394 can delay or reduce the number of renal
      flares. It is possible that if renal flares can be delayed or reduced, patients may be able
      to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of
      the side effects associated with these treatments.
    

Intervention name(s): Abetimus sodium (LJP 394)
Intervention type(s): Drug
Intervention MeSH terms: Abetimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Immunologic Diseases; Autoimmune Diseases; Systemic Lupus Erythematosus; SLE; Lupus Nephritis; Lupus Glomerulonephritis
Treatment of Localized Low Grade Lymphomas
Condition: Lymphoma, Low-Grade
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of
      chemotherapy in the treatment of localiezd low grade lymphoma
    

Detailed description: 
      The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long
      term remissions to some patients .

      No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is
      to determine wether prednisone administrated after first line local radiotherapy (30 GY) can
      pre in the treatment of localized low grade lymphomas of adult patients
    

Intervention name(s): radiotherapy; MINI CHEP
Intervention type(s): Procedure; Drug
Intervention description(s): mini chep+ radiotherapy; chemotherapy minichep 6 courses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized low grade lymphoma; Chemotherapy; Radiotherapy; Molecular analyses; primary
Exploring 8-iso Prostaglandin F2α and Adenosine Deaminase Levels in Periodontal Health and Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This study aims to assess the diagnostic potential of gingival crevicular fluid (GCF)
      biomarkers, specifically 8-iso Prostaglandin F2α (8-iso-PGF2α) and adenosine deaminase (ADA),
      in evaluating periodontal health and disease conditions.
    

Detailed description: 
      Conducted as a single-blind, cross-sectional investigation, this study comprised 26
      individuals categorized as periodontally healthy, 27 with gingivitis, and 27 diagnosed with
      periodontitis. The participant pool included individuals with various periodontal concerns
      who were referred to the Department of Periodontology Clinic at Kahramanmaraş Sütçü İmam
      University. The classification of periodontal health, gingivitis, and chronic periodontitis
      adhered to the 2018 criteria outlined by the European Federation of Periodontology
    

Intervention name(s): 8-iso Prostaglandin F2α and Adenosine Deaminase
Intervention type(s): Diagnostic Test
Intervention description(s): We took gingival crevicular fluid samples from patients who applied to our clinic and evaluated the -iso Prostaglandin F2α and Adenosine Deaminase levels in the samples.
Intervention MeSH terms: Adenosine; Dinoprost; Dinoprost tromethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 8-isoprostane, adenosine deaminase, GCF
Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate the change of the optic nerve sheath diameter
      according to the change of the neck position in pediatric patients undergoing palatoplasty.
    

Detailed description: 
      Palatoplaty is performed under neck extension in patients with cleft palate. The purpose of
      this study is to evaluate the effect of neck extension on the ultrasonographic optic nerve
      sheath diameter during palatoplasty.
    

Intervention name(s): Neck extension
Intervention type(s): Procedure
Intervention description(s): The neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older
        and under 24 months
Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the
      response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not
      amenable to curative surgery, or recurrence after prior surgery, who have had no prior
      chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor
      response population.
    


Intervention name(s): pemetrexed; cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): 700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles; 75 mg/m2, IV, every 21 days x 6 cycles
Other intervention name(s): LY231514; Alimta
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSA
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Hypotension, Orthostatic; Hypotension; Atrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor
      symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following
      randomization to continued therapy with droxidopa or placebo.
    

Detailed description: 
      Background :

      Multiple system atrophy (MSA) is a rare, sporadic progressive neurodegenerative disorder,
      rapidly leading to severe disability and impairment of quality of life. MSA is characterized
      by a variable combination of a poor levodopa parkinsonism and /or cerebellar ataxia and
      autonomic failure (cardiovascular and / or bladder and sexual dysfunction) (Gilman et al,
      2008). The prevalence is approximately 4-5 cases per 100 000 inhabitants.

      Orthostatic hypotension (OH) is one of the major symptoms of MSA, present in a large majority
      of patients, leading to significant disability because of impaired balance, falls and
      possibly syncope. Drugs available to treat OH in this disease are very limited.

      L-ThreoDOPS (L DOPS or DroxiDopa) is an orally administered synthetic catecholamine acid that
      is converted to the sympathetic neurotransmitter norepinephrine (NE) through a single step of
      decarboxylation by the endogenous enzyme 3,4-dihydroxyphenylalanine (DOPA) decarboxylase. It
      prevents symptoms related to OH by central and/peripheral mechanisms. This drug is currently
      developed for "neurogenic OH" by Chelsea Therapeutics on the basis of short duration
      placebo-controlled randomized trials. Besides an expected effect on OH, L-DOPS may also, by
      noradrenergic stimulation, improve some motor and non-motor symptoms common and disabling in
      MSA patients such as akinesia and fatigue.

      In this context, the French reference center for MSA and the 12 national centers with
      identified skills to manage this disease, propose to conduct a national multicenter
      randomized clinical trial versus placebo to evaluate the long term efficacy (3 months) of
      L-threo DOPS on the OH and other non-motor symptoms in MSA patients.
    

Intervention name(s): L-Threo DOPS; placebo
Intervention type(s): Drug; Drug
Intervention description(s): initial dose titration period (4 weeks) followed by 8 weeks at the max tolerated dose; initial period (4 weeks) followed by 8 weeks
Other intervention name(s): L DOPS or DroxiDopa
Intervention MeSH terms: Droxidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L-threo DOPS (DroxiDopa); Orthostatic Hypotension; Multiple system atrophy
Pain Control With Total Knee Replacement
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to study the effects of gabapentin on pain control in the
      perioperative and post-operative period of total knee arthroplasty.
    

Detailed description: 
      Being able to understand and better control pain in patients undergoing total knee
      arthroplasty will help in many different areas of medicine. Gabapentin is one pain control
      modality that has been used by many different orthopaedic surgeons with excellent
      retrospective results. Gabapentin, however, has never been studied, to the investigators
      knowledge, in a prospective randomized fashion in the United States for total knee
      arthroplasty. This study will be the first of its kind to truly compare the effects of
      gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo
      for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep
      quality.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Other intervention name(s): Fanatrex; Gabarone; Gralise; Horizant; Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of a Manualized Short-term Treatment of Internet and Computer Game Addiction
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to 1) determine the efficacy of manualized Short-term Treatment
      of Internet and Computer game Addiction (STICA), assess 2) the durability of treatment
      response in these patients and 3) the impact on associated psychiatric symptoms, e.g. social
      anxiety and depression.
    


Intervention name(s): STICA Intervention
Intervention type(s): Behavioral
Intervention description(s): Manualized Short-term Treatment for Internet and Computer game Addiction (STICA) based on cognitive behavior-therapy (combining individual and group therapy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: internet addiction; computer game addiction; STICA; short-term treatment; psychotherapy; internet and computer game addiction
Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating
Condition: Antidepressant Induced Excessive Sweating
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be
      effective in reducing excessive sweating caused by antidepressant treatment, and will have
      minimal adverse effects.
    

Detailed description: 
      Sweating is a common and bothersome side effect of treatment with antidepressants. Most or
      all antidepressants have been clearly shown to cause excessive sweating. It is unclear to
      what extent excessive sweating caused by antidepressants becomes less or goes away with time.
      In many instances, it continues to be a problem even after 6 or more months on the
      antidepressant.

      There is no generally accepted treatment for excessive sweating. This study has been designed
      to study whether terazosin is effective in reducing antidepressant-induced sweating, and
      whether it is well-tolerated and acceptable to patients. In addition, secondary objectives of
      this study are to determine the time taken for patients to respond to terazosin, the usual
      doses needed for improvement, and the extent of reduction in sweating. This information will
      not only help doctors in using terazosin for this purpose in their patients, but will help in
      designing further studies of this treatment.
    

Intervention name(s): terazosin
Intervention type(s): Drug
Other intervention name(s): Hytrin
Intervention MeSH terms: Terazosin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant induced excessive sweating
Dietary Choice in Active Older Adult Women
Condition: Exercise Addiction; Diet Habit; Obesity; Overweight; Weight Loss
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The present study aimed to determine the effects of negative-calorie diet supplemented with
      exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie
      diet with exercise among elderly adult women with abnormal weight gain.
    

Detailed description: 
      Background: Negative-calorie diet is among the popular dieting guides for weight loss;
      however, there is still little knowledge about this method.

      Objectives: The present study aimed to determine the effects of negative-calorie diet
      supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency
      with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

      Material and Methods: Participants included sedentary women (age 45-75 years) with overweight
      or obesity (n=111). They were randomly divided into two groups including negative calorie
      diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons
      completed the treatment. The weight assessment parameters including change in weight and body
      composition, blood sample tests were performed pre- and three month post-intervention.
    

Intervention name(s): NCDsport; LCDsport
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Negative Calorie Diet supplemented with exercise; Low-Calorie diet with exercise
Other intervention name(s): group I; group II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet; Exercise; Obesity; Overweight; Weight loss