bioihbjkbjnl/mcl2 huggingface dataset:
Speed of Processing Training to Improve Cognition in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate the effectiveness of a computerized
      technique designed to improve processing speed (i.e. the amount of time it takes for a
      person's brain to process information) in a multiple sclerosis (MS) population. The study is
      designed to study how well this technique can help people with MS increase their processing
      speed and their ability to function better in everyday life. This treatment protocol has been
      studied extensively with older adults, showing improvements on standard laboratory measures
      of processing speed and performance of activities of daily living.
    

Detailed description: 
      This study is a double-blind, placebo-control randomized clinical trial examining the
      efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits
      in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in
      individuals with MS and such deficits have been shown to exert significant negative impact on
      multiple aspects of everyday life, including occupational and social functioning. Despite
      these findings, few studies have attempted to remediate PS deficits in order to improve the
      everyday functioning of individuals with MS. This study is designed to (1) apply a treatment
      protocol for PS impairments well-validated in an aging population to individuals with MS with
      objectively observable deficits in PS and document its efficacy on standard
      neuropsychological outcome measures. In addition, the investigators will (2) assess the
      effectiveness of the intervention utilizing global measures of everyday life, including an
      objective measure (the Timed Activities of Daily Living; TIADL), as well as additional
      questionnaires to be completed by both the participant and a significant other. This study is
      also designed to (3) examine the influence of degree of PS impairment on treatment efficacy
      using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol
      and (5) examine the utility of booster sessions to facilitate long-term treatment effects.
    

Intervention name(s): Speed of Processing Training (SPT); Placebo Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Processing Speed; Intervention; Multiple Sclerosis; Cognition
PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Headache; Flushing
Study type: Interventional

Summary: 
      The aim is to investigate the incidence of headache, migraine attacks and flushing after
      pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with
      sumatriptan in patients with migraine
    

Detailed description: 
      Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine
      pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine
      patients and will induce flushing in all patients. We are investigating whether treatment
      with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and
      migraine is induced.

      The purpose of this study is to investigate PACAP38-induced headache and migraine in patients
      with migraine who have been treated with either sumatriptan or placebo using
      purpose-developed standardized interview. The study will be conducted with a double-blind,
      placebo-controlled crossover study design.
    

Intervention name(s): Imigran; Isotonic Saline; Pituitary adenylate cyclase-activating peptide-38
Intervention type(s): Drug; Other; Other
Intervention description(s): All patients will undergo this intervention on one of two study days; All patients will undergo this intervention on one of two study days; All patients will undergo this intervention on both study days
Other intervention name(s): Sumatriptan; PACAP38
Intervention MeSH terms: Sumatriptan; Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral
      contraceptives with non-use, focusing specifically on Valette® compared to other users of low
      estrogen dose combined oral contraceptives.
    

Detailed description: 
      This is a population-based case-control study in Germany.

      Cases are women who are between 15 and 49 years old with a diagnosis of venous
      thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December
      2007.

      Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4
      controls matched by year of birth and region will be allocated to each case.

      Both cases and controls will receive a similar self-administered questionnaire except of some
      case-specific questions which are not applicable for the controls.

      Study participants will be asked for their informed consent. Data confidentiality will be
      ensured by the Berlin Center for Epidemiology and Health Research.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and
        2007

        Controls: population sample
      
Keywords: venous thromboembolism
A Study of AST-008 in Healthy Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to
      evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.
    


Intervention name(s): AST-008
Intervention type(s): Drug
Intervention description(s): AST-008 is a toll-like receptor 9 agonist.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Screening
Analgesic Effect of M-TAPA on LC
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect
      on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery.

      Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet
      University, Sivas, Turkey, from April 2023 to May 2023.

      Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no
      block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had
      bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the
      surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS)
      and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol
      consumption was calculated.
    


Intervention name(s): modified thoracoabdominal nerve block through perichondrial approach
Intervention type(s): Procedure
Intervention description(s): Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: modified thoracoabdominal nerve block through perichondrial approach; postoperative pain; laparoscopic cholecystectomy
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and blood pressure lowering effect of
      different doses of PF-00489791 in patients with mild to moderate high blood pressure
    


Intervention name(s): placebo; PF-00489791; PF-00489791; PF-00489791
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): placebo, oral, tablets, once daily, for 28 days; PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days; PF-00489791 4 mg, oral, tablets, once daily, for 28 days; PF-00489791 10 mg, oral, tablets, once daily, for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Clinical Trial; Randomized Controlled Trial; Humans; Cyclic Nucleotide Phosphodiesterases Type 5
Scalpel vs Diathermy in Repeat Cesarean Delivery
Condition: Complications; Cesarean Section
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in
      pregnant patients undergoing repeat elective cesarean delivery.
    

Detailed description: 
      It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat
      cesarean delivery will have less incision time, as well as less blood loss. A second
      hypothesis is that the use of diathermy, compared with scalpel will not increase in
      post-operative pain.

        1. This is a randomized prospective study in women undergoing elective repeat cesarean
           delivery at Medical Center Hospital in Odessa Texas.

        2. Women undergoing cesarean delivery will be randomized into two groups: One group will
           undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous
           tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel
           will be used to achieve the same aim.

        3. A standardized abdominal wall incision will be made with either diathermy in cut mode or
           scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons
           preference. All patients in the study will get standard skin incision in terms of length
           and depth which will be marked by a ruler.

        4. Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding
           will be measured. Blood loss will be calculated by weighing (in grams) the "used" lap
           sponges and comparing this to the weight (in grams0 of "fresh" lap sponges.

        5. Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will
           be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.
    

Intervention name(s): scalpel; Diathermy
Intervention type(s): Device; Device
Intervention description(s): used to cut the abdominal wall.; Diathermy used to cut , coagulate the tissue
Other intervention name(s): Blade; Bovie
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study will be conducted to evaluate the outcomes of action observation therapy on fine
      motor skills of affected upper limb among patients with chronic stroke.
    

Detailed description: 
      The data for study will be collected for the duration of 5 months, data will be collected at
      1st, 4th, 8th, 12th and then at 16th week of follow up. It is a Randomized Control Trial.
      Patients will be selected by Consecutive Sampling from Ittefaq Hospital Trust, Lahore. All
      patients were right handed prior to stroke. Screening tools used will be Canadian
      Neurological Scale, the Mini-Mental State Examination (MMSE), the Bell Barrage test, and the
      ideomotor apraxia test (SpinnlerRognoni).Tests for assessment will be Fugl-Meyer test (FM)
      (of the upper limb), Frenchay Arm test (FAT), Box and Block test (BBT), Modified Ashworth
      Scale (AS) and Functional Independence Measure Motor items (FIMM). The SPSS version 21 will
      be used for analyzing data. The descriptive data will be expressed in Frequency and
      Percentages, while within the group differences will be measured by Mixed Model Anova.
    

Intervention name(s): Neurodevelopmental Techniques; Action observation Therapy
Intervention type(s): Other; Other
Intervention description(s): )Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.; (a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min). + Conventional treatment protocol as in group A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Psychological Treatment of Overweight Binge Eaters Minority Supplement
Condition: Binge Eating Disorder; Cognitive Therapy/Methods; Mental Disorders/Epidemiology; Obesity/Epidemiology; Obesity/Therapy
MeSH terms: Obesity; Overweight; Bulimia; Feeding and Eating Disorders; Mental Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating
      disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but
      its long-term impact and time course on other BED-related symptoms remain largely unknown.
      This study compares the effects of group CBT and group IPT across BED-related symptoms among
      overweight individuals with BED.
    

Detailed description: 
      Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating
      disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but
      its long-term impact and time course on other BED-related symptoms remain largely unknown.
      This study compares the effects of group CBT and group IPT across BED-related symptoms among
      overweight individuals with BED. METHODS: One hundred sixty-two overweight patients meeting
      DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or
      group IPT. Assessments of binge eating and associated eating disorder psychopathology,
      general psychological functioning, and weight occurred before treatment, at posttreatment,
      and at 4-month intervals up to 12 months following treatment. RESULTS: Binge-eating recovery
      rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and
      at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly
      through follow-up but remained significantly below pretreatment levels. Across treatments,
      patients had similar significant reductions in associated eating disorders and psychiatric
      symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly
      in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased
      significantly but only slightly, with the greatest reduction among patients sustaining
      recovery from binge eating from posttreatment to 1-year follow-up. CONCLUSIONS: Group IPT is
      a viable alternative to group CBT for the treatment of overweight patients with BED. Although
      lacking a nonspecific control condition limits conclusions about treatment specificity, both
      treatments showed initial and long-term efficacy for the core and related symptoms of BED.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Interpersonal Therapy (IPT)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Body Mass Index; Bulimia/therapy; Comorbidity; Interpersonal Relations; Psychotherapy/methods
Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
Condition: The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Prospective study comparing hemodynamic and respiratory changes and exercise capacity during
      Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of
      premature infants and term controls
    

Detailed description: 
      The study population included 4 groups of infants; preterm infants born < 300 weeks'
      gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants
      born < 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks'
      gestation) and term controls.

      Pulmonary function testing and spirometry were measured Participants performed CPET on an
      electronically braked cycle ergometer. During the exercise testing, serial saturation, heart
      rate and blood pressure measurements were obtained.

      The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the
      study.
    

Intervention name(s): Cardio-Pulmonary-Exercise-Testing (CPET)
Intervention type(s): Diagnostic Test
Intervention description(s): Cardio-Pulmonary-Exercise-Testing (CPET) . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants performed CPET on an electronically braked cycle ergometer . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study.
Masking: None (Open Label)
Primary purpose: Other
Study of ALXN2050 in Healthy Adult Participants of Japanese Descent
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in
      healthy participants of Japanese descent.
    


Intervention name(s): ALXN2050; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet.; Oral tablet.
Other intervention name(s): ACH-0145228 (formerly)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ALXN2050; Pharmacokinetics; Pharmacodynamics; Japanese Descent
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and
      efficacy of orally administered ATR-101 in subjects with classic congenital adrenal
      hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to
      6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of
      5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
    


Intervention name(s): ATR-101
Intervention type(s): Drug
Intervention description(s): 125-1000 mg twice per week
Other intervention name(s): Nevanimibe hydrochloride
Intervention model: Single Group Assignment
Intervention model description: Single treatment arm with up to 5 planned dosing periods with escalating doses. Subjects were dosed with each dose level for 2 weeks, followed by 2 weeks of matching placebo (subjects blinded).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ATR-101; classic congenital adrenal hyperplasia; 21-hydroxylase deficiency; CAH
EEG Detection of Delirium
Condition: Post Operative Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at
      the bedside. It is an easy-to-use device that only requires the operator to place an adhesive
      strip of electrodes on the patient's forehead, connected to the device. The goal of this
      study is to determine EEG thresholds for the diagnostic of delirium.

      Methods : This prospective observational study includes patients undergoing orthopedic or
      degestive surgery. Each subject will have an EEG reading before surgery and twice daily after
      surgery until discharge or up to 5 days. Patients will be monitored for post operative
      delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a
      geriatrician. EEG relative power reading will be compared between patient with and without a
      delirium diagnostic.
    


Intervention name(s): Prefrontal EEG (VEEGix by NeuroServo)
Intervention type(s): Device
Intervention description(s): Prefrontal EEG reading
Intervention model: Single Group Assignment
Intervention model description: Prospective observational study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Post operative delirium; Older Adults; Electroencephalography