bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Discarded Laboratory Pathological Specimens and Media
Condition: Non-viable Oocytes; Extra Spermatozoa; Seminal Fluid; Granulosa Cells; Serum; Follicular Fluid; Conditioned IVF Media
Study type: Observational

Summary: 
      The researchers propose to investigate the causes, incidence, and time-related events of
      chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility
      drugs utilized, and in vitro laboratory culture conditions.
    

Detailed description: 
      We propose to identify a group of parameters that have significant predictive value for
      assisted reproductive technology outcomes. We seek to test, standardize and implement better
      methods for the freezing of oocytes and sperm prior to these techniques being used in the
      clinical setting. We seek to develop new methods to optimize the determination of genes and
      chromosomes in gametes. We hope to develop new cell surgery or micromanipulation techniques
      (e.g. use of cell drills and lasers in order to enhance the efficiency of procedures such as
      ICSI, assisted hatching, biopsy) as well as other manipulations. We will test the safety and
      efficiency of micro fluidics and automation in the Embryology lab. This has the potential to
      reduce cost, human errors, temperature and physical changes. We hope to develop new methods
      and media and media supplements normally found in the reproductive tract that allow for
      higher survival of gametes in vitro. We will also test the proficiency of laboratory staff
      members on techniques and/or procedures performed in the in-vitro fertilization laboratory.
      We will perform Quality Control to review how changes in temperature and setting can effect
      specimens
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing infertility treatment.
      
Biospecimen description: 
      Samples with DNA: Non-viable oocytes, spermatozoa, granulosa cells and follicular fluid
      Samples without DNA: seminal fluid, serum and conditioned IVF media
    
Keywords: discarded pathological specimens; discarded media; IVF
First in Man Evaluation of Single and Multiple Doses of Oral ATX2417
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      First in man evaluation of single and multiple doses of compound ATX2417 in healthy male
      volunteers. A double blind placebo controlled parallel group ascending dose design; up to
      five dose levels for the single dose and up to two dose levels for the multiple dose (8 days
      of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial
      and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and
      pharmacokinetic profile. A fasted/fed comparison will also be included in the single
      ascending dose part of the trial.
    

Detailed description: 
      The study consists of two parts, A (single ascending dose including fasted/fed comparison)
      and B (multiple ascending dose). Part B will be conducted after a thorough review by the
      Sponsor and the Principal Investigator of the data arising from part A.

      Part A This will be a randomised, double blind, placebo controlled, parallel group titration
      of up to seven single dose levels of ATX2417. In each cohort, six subjects will receive
      active compound and two will receive placebo in a randomised fashion. At each dose level, 2
      subjects (1 subject will receive ATX2417 and 1 subject will receive placebo) will be dosed on
      Day 1 and the remaining 6 subjects will be dosed at least 24 hours later. Safety and
      pharmacokinetic observations will be made. There will be a minimum of two weeks between the
      first dosing day at each dose level. Safety and ATX2417 pharmacokinetic data will be reviewed
      prior to each dose escalation and, based on pharmacokinetic data, it is also possible to
      decrease the dose if the pharmacokinetic profile so indicates. This part will also include an
      assessment of the effect of a high fat breakfast on the absorption and pharmacokinetic
      profile of ATX 2417, performed at a dose predicted to be associated with therapeutic plasma
      concentrations.

      Part B Following completion of Part A, and selection of appropriate dose levels, Part B will
      be performed. This will be a randomised, double blind, placebo controlled, parallel group
      study of up to two dose levels of ATX2417 given once daily for eight days. In each cohort,
      six subjects will receive active compound and two will receive placebo in a randomised
      fashion. Safety and pharmacokinetic observations will be made.
    

Intervention name(s): ATX2417; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomised double blind parallel group ascending dose assessment; Randomised double blind parallel group ascending dose assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: allergy
Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
Condition: Ovarian Hyperstimulation
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian
      hyperstimulation syndrome in context of assisted reproductive technologies aiming in its
      prevention
    

Detailed description: 
      Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high
      risk for developing ovarian hyperstimuation syndrome were received either oral
      Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or
      received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and
      continued for 4days
    

Intervention name(s): Oral Cabergoline; Calcium Gluconate
Intervention type(s): Drug; Drug
Intervention description(s): Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days; Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days
Other intervention name(s): Cabergamon; Calcium
Intervention MeSH terms: Calcium, Dietary; Cabergoline; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Calcium infusion; Cabergoline
The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time
Condition: Time to Reach 90% Endtidal Oxygen During Preoxygenation
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the preoxygenation time by observing patients undergoing
      preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the
      clinic.
    

Detailed description: 
      Criteria for inclusion in the study:

      Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years
      50 patients

        1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during
           preoxygenation will be included.

        2. Group: Patients undergoing preoxygenation without CPAP will be included

      In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal
      CO2 value in this order will be recorded.

      Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation
      and after intubation.
    

Intervention name(s): CPAP preoxygenation
Intervention type(s): Other
Intervention description(s): During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: CPAP(Continuous Positive Airway Pressure); Standard preoxygenation
Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States
Condition: Reflux Oesophagitis
MeSH terms: Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study were:

        -  To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect
           to their effects on basal- and food- stimulated gastric pH in healthy volunteers.

        -  To assess whether there is a relationship between the pharmacokinetics of YF476 and
           gastric pH in healthy volunteers.

        -  To assess the safety and tolerability of single doses of YF476 in healthy volunteers.
    

Detailed description: 
      YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and
      meal-stimulated gastric acid secretion and enhance gastric emptying of a liquid meal in man.
      Therefore YF476 might benefit patients with reflux oesophagitis. The compound has been well
      tolerated in animal toxicity studies at doses in excess of the projected therapeutic dose in
      patients, and merits studies in healthy volunteers. Extrapolation from data obtained in
      animals suggests that a single oral dose of about 10mg of YF476 should compare favourably
      with an oral dose of 150mg of ranitidine in man with respect to effect on basal and
      food-stimulated gastric acid secretion. Therefore in the proposed study a range of doses of
      YF476 encompassing that dose will be studied; the exact dose of YF476 will be chosen on the
      basis of the previous study but the top dose will not exceed 100mg. 24-hour ambulatory
      gastric pH will be monitored via an intragastric pH electrode (7-10). Although there is
      variability between subjects with respect to the effects of food and drug treatment on
      gastric pH, the methodology for measurement of ambulatory gastric pH is robust.
    

Intervention name(s): YF476; Ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100 mg), placebo and ranitidine 150 mg. There were at least 7 days between consecutive Treatment Days.; There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100mg), placebo and ranitidine 150mg. There were at least 7 days between consecutive Treatment Days.
Intervention MeSH terms: Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; gastric pH; healthy subjects; ranitidine
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home
Condition: Suspected Sleep Apnea; Daytime Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional

Summary: 
      The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to
      the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it
      could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of
      domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and
      agreement in the therapeutic decision. 2) Direct costs of patients included in the study.
      Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home
      with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport
      agency from home to home in order to be universal the access to this diagnostic model. The
      file transmission with the raw data of the study will be made telematically by GPRS. If the
      aims of the study reach an end there will be a considerable change in the clinical practice
      making possible the international acceptation of domiciliary PR as diagnosis of SAHS and
      adapting the diagnosis of this syndrome to the new technologies of communication. The
      universalization of domiciliary PR would make possible that the diagnosis of SAHS could be
      done in any patient and in any country with GPRS technology and a transport agency, that is
      to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and
      there is association between sleep apneas and cardiovascular risk, in the immediate future we
      must evaluate this disease as we do today with the cholesterol determination. If our results
      are as predicted, the primary care physician could start and in a lot of cases finish the
      SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would
      alleviate a lot the process cost all over the world.
    


Intervention name(s): PSG (polysomnography); PR (respiratory polygraphy)
Intervention type(s): Device; Other
Intervention description(s): POLYSOMNOGRAPHY; respiratory polygraphy: level III of AASM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso
Condition: Nutrition
Study type: Interventional

Summary: 
      This project targets vulnerable populations of smallholders, women and children and should
      lead to increased poultry production, increased egg consumption of children, improved
      nutrition, and increased household level resilience. This innovative intervention will be the
      gifting of chickens by religious leaders to children ages 6 to 12 months coupled with
      integrated nutrition and agricultural trainings.
    

Detailed description: 
      This study involves innovative behavioral change theoretical methodology to empower
      caregivers as smallholder poultry producers by improving their access to livestock production
      resources and agricultural extension services, providing tools for improved decision making,
      and enhancing nutrition based knowledge. Smallholder production is important in eliminating
      food insecurities and building resilience to improve nutrition in children under 5. Based on
      the results of the Ethiopian egg project, through messaging and education, this study will
      foster favorable attitudes and consequent behavioral changes, including increased egg
      consumption.
    

Intervention name(s): Integrated nutrition and agricultural (INA) trainings; Ceremonial Gifting of Livestock
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.; Egg laying chickens will be presented as a gift to the child by a community champion (their religious leader or village chief)) during a gifting ceremony
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia
Condition: Hypertension With Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan
      combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients
      with hyperlipidemia
    


Intervention name(s): Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg; Amlodipine 10 mg + Valsartan 160 mg; Valsartan 160 mg + Rosuvastatin 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Valsartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this randomized clinical trial is to compare the analgesic efficacy and side
      effect profile of IV acetaminophen as an analgesic adjunctive medication to IV hydromorphone
      for the treatment of acute pain experienced by patients in the Emergency Department (ED).
    

Detailed description: 
      Multimodal treatment of pain is a commonly used strategy to control pain by combining
      analgesics with different and complementary mechanisms of action. Oral acetaminophen combined
      with opioids is a mainstay of treatment of mild to moderate pain, while the use of IV opioids
      is the standard for treatment of severe pain in the Emergency Department. An IV formulation
      of acetaminophen is widely used in Europe and has recently been approved in the US. It has
      been studied for treatment of acute post-operative pain and renal colic.

      This randomized trial was designed to assess the effectiveness of the combination of IV
      acetaminophen and IV hydromorphone as a strategy to provide more effective treatment of acute
      severe pain in the Emergency Department with the possibility of reducing opioid consumption.
      All patients received 1 mg of IV hydromorphone. They were then randomized to receive either 1
      g of IV acetaminophen or 100 mL of normal saline placebo. Measures of pain, vital signs, and
      presence of side effects were obtained immediately before IV hydromorphone was administered.
      Following receipt of the acetaminophen or placebo these same variables were measured at 15
      minute intervals for the next 120 minutes. Additional analgesics were administered if
      patients requested them. Subsequent care of the patients was at the discretion of the
      treating attending physician.
    

Intervention name(s): IV acetaminophen; IV placebo; hydromorphone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): acetaminophen given intravenously; given intravenously; hydromorphone given intravenously
Other intervention name(s): Ofirmev; normal saline; Dilaudid
Intervention MeSH terms: Acetaminophen; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; opioid analgesics; Emergency Department; randomized controlled trial; acetaminophen; hydromorphone
Effects of Single Dose Tadalafil on Urethral and Anal Closure Function
Condition: Urinary Incontinence,Stress; Fecal Incontinence
MeSH terms: Fecal Incontinence; Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive
      comparator) on the urethral - and anal pressure and on urine flow in healthy females.
      Further, the purpose of the trial is to evaluate the potential for going forward with studies
      of tadalafil in patients suffering from urine or fecal incontinence.
    


Intervention name(s): Tadalafil 40 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose on study day 1/2; Identical to active IMP
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period (AB/BA) crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Erythema Toxicum Neonatorum in Newborns and the Development of Asthma
Condition: Asthma; Erythema Toxicum Neonatorum
MeSH terms: Asthma; Erythema
Study type: Observational

Summary: 
      Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term
      babies. Several authors have commented on the possible relationship between ETN and the
      development of atopic conditions, such as atopic dermatitis or respiratory disease later in
      life. There is a paucity of research addressing this issue.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Case studies will include subjects between the ages of 3-9 years who have had at least 2
        asthma diagnoses within the last 2 years. Patients will be selected based upon their ICD9
        codes for asthma. Control subjects will be age matched and without an asthma diagnosis.
Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome
Condition: Burnout-Syndrome
MeSH terms: Syndrome; Burnout, Psychological
Study type: Interventional

Summary: 
      Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling
      compared to conventional standard diet and lifestyle counseling in outpatient mothers with
      burnout-syndrome.
    

Detailed description: 
      Ayurveda is a traditional Indian medicine: as a whole medical system it consists of
      diagnostic procedures and complex treatments. Ayurveda-treatment is based on Ayurvedic
      diagnosis and has a special focus on lifestyle and nutritional counseling, based on the
      individual constitution of the patient. Ayurvedic counseling can easily be followed by the
      patients in their day-to-day life and is an inexpensive way of self-care. In Ayurveda it is
      often used for the treatment of burnout-syndrome. However, no systematic data is available on
      its effectiveness in comparison to conventional standard diet and lifestyle counseling. The
      aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling
      compared to conventional standard diet and lifestyle counseling in outpatient mothers with
      burnout-syndrome.
    

Intervention name(s): Diet and Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Diet and Lifestyle Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Burnout-Syndrome; Ayurveda; Ayurvedic; Traditional Indian Medicine; CAM; Whole Medical System; Diet and Lifestyle Counseling
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
    

Detailed description: 
      open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient
      bioequivalence study
    

Intervention name(s): pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy