bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety
      and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.
      Since both of these medications have independently shown promise in helping with cocaine
      abuse we are proposing that together they may be even more successful in the treatment of
      cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of
      the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine
      abstinence among cocaine-dependent patients. This study includes free treatment for cocaine
      dependence that includes medication.
    

Detailed description: 
      Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine
      abstinence among cocaine-dependent patients.

      Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence
      (via urine toxicology) for three consecutive weeks during the study will be significantly
      greater for the combined pharmacotherapies group compared to the placebo group.

      Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be
      greater in the combined pharmacotherapies group compared to the placebo group.

      Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the
      number of using days per week), as measured by the time-line follow-back method, will show a
      greater reduction in use for the combined pharmacotherapies group compared to the placebo
      group.

      Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among
      cocaine-dependent patients.

      Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined
      pharmacotherapies group compared to the placebo group.

      Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global
      functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of
      mechanism of action.
    

Intervention name(s): Adderall-XR and Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adderall-XR 60mg/day and Topiramate 300mg/day; Placebo
Intervention MeSH terms: Topiramate; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine; Adderall; Topiramate; ADHD
A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
Condition: Healthy Volunteers; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at how two different semaglutide versions reach and stay in the blood
      after injection. The study aims to show similar levels of semaglutide in the blood when using
      the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide.
      Which version participants get is decided by chance. One version is the one that doctors
      already can prescribe and the other is the new version. Participants will get the medicines
      as an injection under the skin of the stomach with the use of a pen-injector. The type of
      pen-injector is different for the two versions of semaglutide. The study will last for about
      80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the
      visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have
      to stop the study if the study doctor thinks that there are risks for their health. Women
      cannot take part if pregnant, breast-feeding or planning to become pregnant during the study
      period.
    


Intervention name(s): Semaglutide
Intervention type(s): Drug
Intervention description(s): Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Condition: Non-infectious Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and
      efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
    


Intervention name(s): ADX-102 Ophthalmic Solution (0.5%); Vehicle of ADX-102 Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.; Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Other intervention name(s): Reproxalap; Vehicle of Reproxlap
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: reproxalap
Children's Intake of Foods Reduced in Energy Density
Condition: Vegetable Intake
Study type: Interventional

Summary: 
      The purpose of this research is to investigate children's responses to incorporating
      vegetables into selected entrees and snacks over several days. The hypothesis is that
      children will increase their vegetable intake by consuming foods that have been reduced in
      energy density through the addition of vegetables. Effects on energy intake will also be
      examined.
    


Intervention name(s): Energy density feeding study
Intervention type(s): Other
Intervention description(s): In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The objective of this study is to detect the evidence on the immune response following acute
      SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to
      SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after
      infection for both symptomatic and asymptomatic patients.
    

Detailed description: 
      A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled
      were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab
      specimens.

      For the study, serum samples of the 30 patients will be collected and will be investigated
      for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks
      after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples
      will be collected after that for 6 months later; one serum sample tested every month for 6
      months after.

      The following questions will be addressed:-

        1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2?

        2. How long is the duration of detection of serum IgG antibodies and antibody titres over
           time following infection with SARS-CoV-2?
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients attending sohag university hospital and have recent COVID -19 infection
      
Biospecimen description: 
      serum
    
Keywords: COVID19 IGg
Clinical Applications of a Joystick in Femoral Shaft Fractures
Condition: Femur Shaft Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      This study will use a new "H" joystick for reduction on patients with femur fractures to
      investigate the reduction time, operating time and bone healing status for the evaluation of
      the clinical application benefits of this joystick.
    

Detailed description: 
      This study will design a new "H" joystick for reduction (which has received the national
      utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with
      femur fractures to investigate the reduction time, operating time and bone healing status for
      the evaluation of the clinical application benefits of this joystick.
    

Intervention name(s): "H" joystick; Common reduction methods
Intervention type(s): Device; Procedure
Intervention description(s): A joystick that corrects lateral displacement and angulation for multi-direction reduction; Manual reduction methods without the assistance of any devices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: closed reduction; locked intramedullary nailing
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
Condition: Erectile Dysfunction; Lower Urinary Tract Symptoms
MeSH terms: Erectile Dysfunction; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of Alfuzosin in treating Erectile
      Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline
      in erectile function (EF) domain of International Index of Erectile Function (IIEF).
    

Detailed description: 
      This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be
      screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet
      once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the
      original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group
      receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom
      index.
    

Intervention name(s): Placebo; Alfuzosin
Intervention type(s): Drug; Drug
Intervention description(s): Alfuzosin-matched One tablet once daily; 10 mg once daily
Intervention MeSH terms: Alfuzosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Condition: Episodic Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Evidence-based medicine depends on distinguishing between pharmacological effects and placebo
      effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate
      fundamental questions concerning pharmacological effects, placebo effects and their
      interactions. Relief of symptoms of acute migraine will be the test condition for this
      scientific experiment because of migraine's evident clinical significance and the possibility
      of using participants as their own control during sequential acute migraine attacks. Our
      overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an
      FDA-proven effective medication for acute migraine) and the effects of placebo treatment can
      be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge
      has the possibility to suggest potentially more efficient methodologies to test new
      medications that can be used to augment and enhance the apparatus of the RCT.

      General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo
      effect, how such effects vary in different knowledge/expectations contexts, and mutually
      constitute one another and interact.

      General Hypothesis: The measured pharmacological effect of an effective medication
      (rizatriptan) and the measured effect of placebo treatment are determined significantly by
      different knowledge/expectations contexts.
    


Intervention name(s): Maxalt; placebo pill; placebo pills
Intervention type(s): Drug; Drug; Drug
Intervention description(s): anti-migraine drug; placebo pills; placebo pills
Other intervention name(s): rizatriptan
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Condition: Asthma; Smoking; Steroid Resistance; Corticosteroid Insensitivity
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The
      causes of this phenomenon are currently unknown. The investigators will perform a number of
      blood & breathing tests to try to discover the cause/s behind this phenomenon with the aim of
      producing leads for further investigation and possible new treatments for smokers with
      asthma.
    

Detailed description: 
      Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The
      causes of this phenomenon are currently unknown. However research into steroid resistance in
      severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD)
      points to a number of possible causes. We will characterise a group of smokers with asthma
      and perform a number of investigations and compare the results to ex-smokers and never
      smokers with asthma with the aim of establishing which previously published steroid
      resistance phenomena are related to the steroid resistance displayed by smokers with asthma.
      Results produced from this trial will provide hypothesis generating information leading to
      future pharmaceutical trials.
    

Intervention name(s): oral steroid-dexamethasone
Intervention type(s): Drug
Intervention description(s): 2 week steroid trial
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Smoking; Steroid Resistance; Corticosteroid insensitivity
Bioavailability of Golden Rice Carotenoids in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      This investigation protocol uses an isotope reference method to evaluate bioavailability of
      ß-C in rice and its bioconversion to vitamin A.

      A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of
      β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be
      collected up to 33 days after the doses. The absorption kinetics will be determined by
      tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice
      β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be
      quantitatively determined.
    

Detailed description: 
      Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug
      ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil
      dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix
      dependent, it is necessary to know what the vitamin A equivalency of golden rice
      beta-carotene is. The determination of the absorption and conversion of golden rice
      beta-carotene is of importance for designing food programs in many rice-eating regions of the
      world, where vitamin A deficiency is common.

      To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute
      dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of
      vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin
      A status (n = 15).

      The specific aims of this pilot study are:

        1. To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or
           10 g fat (butter);

        2. To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;

        3. To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A
           status. The determination of the absorption and conversion of golden rice ß-carotene is
           of importance for designing food programs in many rice-eating regions of the world,
           where vitamin A deficiency is common.
    

Intervention name(s): golden rice; corn oil 0g; corn oil 10g; coren oil 5 g
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene; 0 g of corn oil in the golden rice meal; 10g corn oil in the golden rice meal; golden rice meal with 5 g corn oil
Other intervention name(s): golden rice carotenoids
Intervention MeSH terms: Carotenoids
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: golden rice carotenoids; healthy volunteers; retinol equivalence
Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6
      sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence)
      healthy male and female subjects who, at the time of screening, are between the ages of 18
      and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be
      replaced at the Sponsor's discretion. Screening activities will be completed within
      approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6
      treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6
      periods with subjects receiving single doses of pregabalin ER 330 mg target release rate
      tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate
      tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and
      pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments
      will be administered following a 600- 750 calorie, 30% fat evening meal.
    


Intervention name(s): Pregabalin ER; Pregabalin ER; Pregabalin ER; Pregabalin ER; Pregabalin ER; Pregabalin ER
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.; B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.; C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.; D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.; E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.; F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Post-bariatric Abdominoplasty: Skin Sensation Evaluation
Condition: Obesity; Hypesthesia
MeSH terms: Hypesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of
      the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.

      Additional purposes were: quantify topographically the abdominal skin sensation of the Normal
      weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the
      abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line
      Abdominoplasty).
    

Detailed description: 
      Abdominoplasty performed in post-bariatric patients presents more post-operative
      complications than in non post-bariatric patients. Surgical techniques that provokes less
      complications are required.

      Anchor-line abdominoplasty is a technique published in the years 1950 as well the first
      bariatric proceedings. Abdominoplasty without flap undermining is feasible in pendular
      abdominal wall of the former morbidly obese women with scarred abdomen.

      Classical abdominoplasty (with flap undermining) is known to impair significantly the skin
      sensation. Post-bariatric abdominoplasty without flap undermining keeps the skin sensation
      unaltered since the early post-operative period.

      Now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by
      removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves.
      Could this technique improve the skin sensation of the anterior abdominal wall of the
      post-bariatric patients?
    

Intervention name(s): Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.; Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical removal of the exceeding skin and adiposity of the abdominal wall by one midline vertical fuse and one supra-pubic horizontal fuse. Skin suture without flap undermining and with low tension.; Bariatric surgery Plastic surgery Abdominoplasty
Other intervention name(s): Anchor-line abdominoplasty; Abdominoplasty; Post-bariatric plastic surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bariatric surgery; plastic surgery; abdominal wall; skin; sensation; abdominoplasty