bioihbjkbjnl/mcl2 huggingface dataset:
Core Stabilization Versus Routine Routine Exercises in Pelvic Girdle Pain.
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the
      world and it has a major impact on health and functioning as it decreases quality of life.
      The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24-
      36 weeks. The purpose of this study is to compare the effects of stabilization exercises on
      pregnancy induced pelvic girdle pain and its effects on the activity levels as compare to the
      physiotherapy exercises that are routinely prescribed
    

Detailed description: 
      the study is Randomized Controlled trial which will be conducted in the Outpatient Physical
      therapy Department. Patient with suspected PGP will be referred by midwives, physicians or
      directly contact to Physiotherapist. Sample size of 30 individual was calculated by using
      open Epi tool with 95% confidence Interval (CI) and 80% Power. Inclusion criteria for
      patients is 13-28 gestational weeks determined by special test include P4 Test (Posterior
      Pelvic Pain Provocation) and FABER test (Flexion Abduction and External Rotation).
      Individuals would be randomly allocated into two groups by sealed envelope method.

      Assessment will be done at base line and 4th week by using NPRS and PGP Questionnaire. Data
      will be analyzed by using SPSS version 21.
    

Intervention name(s): Core Stabilization exercises; Routinely prescribed exercises
Intervention type(s): Other; Other
Intervention description(s): . Each session will be given for 40 mins (20 mins for TENS and 20 Mins for exercise) Core Stability Exercises include Kegel Exercises, Modified V-sit, opposite Arm Leg Raise, Seated Side bends poses, Dumbell Side bends and Pelvic Tilt. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.; Each session will be given for 40 mins ( 20 mins for TENS and 20 Mins for exercise Routinely prescribed exercises composed of Hamstring stretches, hip flexor stretches, hip extensor stretches, calf stretches, and back extensor stretches. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two groups which will receive physical therapy interventions. one will be experimental and other will be control group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Core Stability Exercises; Pelvic Girdle Pain; Pregnancy; Physical therapy management
Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts
Condition: Healthy
Study type: Observational

Summary: 
      Currently, there are no validated anatomical landmarks that can be used to predict risk of
      and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral
      slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions,
      using healthy individuals without a history of spinal and/or lower extremity pathology. All
      radiographs will be evaluated for the three measurements by four individuals with the intent
      of evaluating inter-observer reliability. Determining the reproducibility of these angles
      between observers will give insight into the potential clinical utility of these measurements
      in evaluating and treating patients with hip-spine syndrome.
    

Detailed description: 
      The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion
      and balance from normal healthy subjects for the purpose of establishing radiographic
      measurements which are reliable and reproducible and which could give insight into the
      potential clinical utility of these measurements as future predictors of who may/may not have
      spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.

      This specific objective of this study will be to measure sacral slope, pelvic femoral angle
      and cup ante-inclination via radiographs in both sitting and standing positions. The
      radiographs will be evaluated for the three measurements by four individuals with the intent
      of evaluating inter-observer reliability.
    

Intervention name(s): X-rays- total of 4
Intervention type(s): Diagnostic Test
Intervention description(s): X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy individuals, both male and females aged 25-50 without major co-morbidities and
        without spine/hip/pelvis issues including previous injuries or surgeries
Impart: Provider-Assisted HIV Partner Notification
Condition: HIV Infections; Partner Communication
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index
      patients recruited from two all-male prisons in Indonesia to assess the acceptability and
      feasibility of provider-assisted HIV partner notification (provider referral) and examine its
      potential to increase the number of partners who are tested for HIV and subsequently linked
      to prevention and treatment services.
    

Detailed description: 
      This study compares three options for partner notification:

        -  Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his
           partner(s) and given information about sites where his partner(s) can receive free HIV
           testing.

        -  Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a
           counselor (project staff) present. Counselor refers the partner to HIV testing,
           including a study-affiliated HIV testing site.

        -  Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the
           partner anonymously - without identifying the participant (index patient). Partners are
           offered immediate HIV testing in their home or at a study-affiliated HIV testing site.
    

Intervention name(s): IMPART; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell), 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together), or 3) have their partner(s) notified confidentially by a disease notifier (anonymous provider referral), who will locate partners, notify them of potential HIV exposure, and offer them HIV testing. Partners with an initial reactive HIV screening test will be referred to care and treatment services.; Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects are responsible for contacting and notifying their partner(s) on their own. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell) or 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together). Subjects may decide which partners to notify and may choose the same or a different method for each partner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: contact tracing; HIV prevention; partner notification
New Use of the ViKY Device for Uterus Positioning
Condition: Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites
    

Detailed description: 
      The ViKY device "Vision Control for endoscopy" was initially a compact motorized endoscope
      holder for laparoscopic surgery. It holds the endoscope and is controlled by either a foot
      pedal or voice activation. It received FDA approval in December 2008 and since that time has
      been used to facilitate laparoscopic surgery in multiple specialties.

      EndoControl now considers using the technology for uterus manipulation in
      laparoscopic-assisted hysterectomies. Most gynecologic surgeries require displacement of the
      uterus out of the anatomic location to optimize the surgery. During an abdominal hysterectomy
      clamps are placed on the uterine cornua allowing easy manipulation of the uterus. The
      development of laparoscopic surgery required new techniques to manipulate the uterus.
      Typically a uterine manipulator is placed vaginally and controlled by the surgeon or the
      surgical assistant during the procedure.

      In conventional operations, the constant physical force decreases the surgical team's
      efficacy and increases fatigue levels. The use of the ViKY device to control the position of
      the uterus facilitates surgery by enabling the surgeon to maintain a constant "locked"
      position or by allowing the surgeon to remotely move the uterus at any point of the surgery.
      The ViKY device also eliminates the need for an extra surgical assistant during
      laparoscopic-assisted hysterectomies.

      The aim of this study is to collect data to demonstrate safety and effectiveness of the use
      of the ViKY device for uterine manipulation during conventional laparoscopic-assisted
      hysterectomies or computer-controlled laparoscopic hysterectomies.
    

Intervention name(s): ViKY UP
Intervention type(s): Device
Intervention description(s): laparoscopic-assisted hysterectomy procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hysterectomies; uterine manipulator
The Effect of an Orange Peel Extract on Exercise Performance
Condition: Exercise Recovery and Endurance
Study type: Interventional

Summary: 
      Rationale: Numerous studies have shown the positive effect of a healthy diet and regular
      moderate exercise. Although, exercise has also been correlated with an increase in reactive
      oxygen species (ROS) production and a higher incidence of injury. ROS production seems to
      induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle
      recovery could be an effective way to increase exercise performance. Several food ingredients
      have been of growing interest due to their specific functioning on the human body. Citrus
      flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of
      citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a
      positive effect on the nitric oxide (NO) synthesis, a known compound in regulating
      endothelial response. This capacity of citrus flavonoids could be useful in stimulating
      performance and recovery after exercise. Additionally, the ability of scavenging ROS could
      reduce muscle damage caused by exercise induced oxidative damage.

      Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise
      recovery and performance.

      Study design: Randomized, double-blind, placebo-controlled study with parallel design, in
      which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a
      pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks
      citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each
      morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.

      Study population: The subjects will be healthy normal weight trained males, with an age of 18
      - 25. Additionally, subjects are non-smokers and free of a medication.

      Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo
      group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive
      weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo
      treatment.

      Main study parameters/endpoints: The main study parameter is the average amount of work load
      produced during the 10-minute time trail test. In addition, oxygen per minute will be
      determined as well as the heart rate. Finally, for each test, the subjective rating of
      perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a
      Borg scale.
    


Intervention name(s): Citrus flavonoid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dose of 500mg divided over two capsules; Daily dose of 500mg divided over two capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: performance; recovery
Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Condition: Extremely Low Birth Weight Infants; Hypernatremia
MeSH terms: Infertility; Hypernatremia; Body Weight; Birth Weight
Study type: Interventional

Summary: 
      The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new
      fluid and electrolyte problems that have not been encountered previously,in particular
      electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium
      value >150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration
      of intravenous fluids(IV)that contain sodium. The current treatment modality for
      hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water
      feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated
      electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease
      elevated electrolytes, there would be less need for large volumes of IVF that contribute to
      the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular
      hemorrhage(IVH)and patent ductus arteriosus(PDA).

      The purpose of this proposed study is to determine whether enteral sterile water feedings is
      effective in decreasing the incidence, duration and severity of hypernatremia in ELBW
      infants.
    


Intervention name(s): Sterile water feedings
Intervention type(s): Other
Intervention description(s): Control group- no intervention
Prophylactic group will receive sterile water feeds starting at 24 hours of life if/or when their serum sodium value is ≥ 145 mEq/L. The volume of sterile water is 10mls/Kg/day based on birth weight, given via continuous infusion feed.
The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L.
The hypernatremia group will receive sterile water feeds when their serum sodium value is ≥ 150 meq/L. The volume of sterile water is 10 mls/Kg/day based on birth weight,given via continuous infusion feed. The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extremely Low Birth Weight Infants; Hypernatremia; Enteral Sterile Water Feeds
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Condition: Retinopathy of Prematurity; Neonatal Cholestasis
MeSH terms: Cholestasis; Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal
      development. Infants born prematurely are at special risk for DHA insufficiency. The source
      of DHA after birth for preterm babies who are not fed full enterally, are mostly fat
      emulsions as the component of total parenteral nutrition solutions which usually do not
      contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered
      from the first day of life and during parenteral nutrition-prevents infants from cholestasis
      and retinopathy of prematurity.
    

Detailed description: 
      During the study period, preterm infants admitted to NICU were included. Infants who weighed
      <1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the
      study. Infants with major congenital anomalies, congenital infections and inborn metabolic
      errors were excluded from the study.

      Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50
      g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L)
      Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12
      g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).
    

Intervention name(s): Fish-oil emulsions; soybean-oil emulsion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fish -oil emulsions:
Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.; soybean-oil emulsion
Other intervention name(s): Smoflipid; Intralipid
Intervention MeSH terms: Soybean oil, phospholipid emulsion; SMOFlipid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and
      7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo),
      double-blind, placebo-controlled study to evaluate the safety of a single dose of oral
      CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's
      Disease.
    


Intervention name(s): Trichuris suis ova; Placebo
Intervention type(s): Biological; Other
Intervention description(s): single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T. suis ova; Crohn's disease
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will collect information about pharmacokinetics (PK), safety and tolerability
      following a single dose of GS-248 in two different oral solid formulations in capsules to
      healthy subjects. It will also collect information about pharmacokinetics (PK), safety and
      tolerability following a single dose of one of the two formulations of GS-248 in fed
      condition.
    

Detailed description: 
      The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a
      single oral dose of two different formulations of GS-248 in fasting conditions. Part II will
      evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in
      fed conditions.

      In Part I, a single oral dose of GS-248 in two different solid formulations will be
      administered to 14 healthy subjects. All subjects will first receive Formulation A and then
      Formulation B. A wash-out period of at least 4 days will be applied between the IMP
      administrations. Both doses contain 120 mg GS 248. For Part I, subjects will come to the
      clinic for single dose administration of Formulation A or Formulation B, respectively, and PK
      and safety assessments. Safety assessments include AE reporting, physical examination, ECG,
      vital signs, body temperature, and blood sampling for analysis of safety laboratory
      parameters.

      After evaluation of the PK profiles of Formulation A and B in Part I of the study, one
      formulation will be selected to be given following intake of a standardised breakfast in Part
      II of the study. Subjects will return to the clinic for a second dose of the selected
      formulation, yet now in fed conditions. The assessments during fed conditions will be the
      same as during fasting conditions except that the subjects will consume a high-fat
      high-calorie breakfast 30 minutes prior to IMP administration.
    

Intervention name(s): Formulation A GS-248; Formulation B GS-248
Intervention type(s): Drug; Drug
Intervention description(s): Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.; Formulation B of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions. Subjects are expected to participate in both Part I and Part II.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects
Condition: Inflammatory Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three-part, single Centre, double-blind, randomized, placebo-controlled
      first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of
      amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly
      male and female subjects (Part 3)
    

Detailed description: 
      This is a three-part, single Centre, double-blind, randomized, placebo-controlled
      first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of
      amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly
      male and female subjects (Part 3).

      The study aim is to assess and characterize the safety and tolerability of single and
      multiple doses of amilo-5MER in healthy young adult subjects and single doses in healthy
      elderly subjects.
    

Intervention name(s): amilo-5MER
Intervention type(s): Drug
Intervention description(s): amilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine).
Other intervention name(s): Synthetic peptide consisting of 5 amino acids
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 of the study was a double-blind, randomised, placebo-controlled assessment of single subcutaneous (SC) ascending doses of amilo-5MER in healthy young adult male subjects. Subjects were enrolled sequentially into 1 of up to 5 cohorts, each containing 8 subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment