bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women
Condition: Contraceptive Usage; Diffuse Noxious Inhibitory Control
Study type: Interventional

Summary: 
      The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse
      noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous
      estrogens sessions and ovulatory period.
    

Detailed description: 
      After being informed about the study and it protocol, all patients giving written informed
      consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus
      to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic
      pressure and heart rates. After, we will evaluate the threshold response and physiological
      rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3
      different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive
      group (CO). Finally, we will compare the mechanical threshold response, physiological rates
      and pain perception between both groups.
    

Intervention name(s): Mechanical stimulus; Thermal (cold) stimulus; Oral contraceptive (OC); No oral contraceptive (No OC)
Intervention type(s): Device; Procedure; Other; Other
Intervention description(s): Electrical dynamometer to measure mechanical pressure; Water cold bath; Oral contraceptive (OC); No oral contraceptive (No OC)
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Study of Having a Female Friend as Labor Support
Condition: Pregnancy; Delivery, Obstetric
Study type: Interventional

Summary: 
      The purpose of this study was to compare labor outcomes in women accompanied by an additional
      support person (doula group) with outcomes in women who did not have this additional support
      person (control group).

      The current study was designed with the benefits of continuous labor support in mind as well
      as the need for a cost-effective, affordable program to provide those services for low-income
      women. Its purpose was to evaluate the effects of continuous labor support provided by a
      female companion of the pregnant person's choosing who, with the mother, had participated in
      an educational program to teach her how to provide continuous labor support.
    

Detailed description: 
      The purpose of this study was to evaluate the influence of a female companion in labor who
      had been chosen by a nulliparous, underinsured, low-income woman and who had received brief
      training in supportive labor techniques. The objective was to compare labor outcomes,
      specifically cesarean section rates, in women accompanied by this additional support person
      (doula group) with outcomes in women who did not have this additional support person (control
      group).
    

Intervention name(s): doula training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: doula; caregivers; labor support; being with woman; continuous labor support; maternal outcomes; Parturition
A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
Condition: Immune System Disorder (Healthy Volunteer)
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
    

Detailed description: 
      Up to approximately 58 days including safety follow up period of 30 days after participant is
      treated with the last dose of study drug.
    

Intervention name(s): Belumosudil mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: capsule; Route of administration: oral; Pharmaceutical form: capsule; Route of administration: oral
Other intervention name(s): KD025; SAR445761
Intervention MeSH terms: Belumosudil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Premenstrual syndrome represents a group of problems affecting most of women in reproductive
      age. These problems include emotional and physical symptoms. In this study the efficacy of
      oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed
      .
    

Detailed description: 
      Premenstrual syndrome (PMS) is deﬁned as the recurrence of psychological and physical
      symptoms in the luteal phase, which remit in the follicular phase of the menstrual cycle
      [1].PMS will be prospectively diagnosed using the Royal college of Obstetricians and
      Gynecologists (RCOG) recommended daily record of severity of problems (DRSP) . Women will be
      asked to fill the diary for 2 months, only women with 30% increase in the DRSP score in the
      week before menses in both months will be diagnosed as having PMS.

      Women with PMS will be invited to participate in the study.The invitation will include a
      clear full explanation of the study and patients will provide written consents. All patients
      consenting to participate will be included in the trial.

      Yasmin, Calver and Placebo will be enclosed in sequentially numbered similar bottles which
      will be numbered using a computer generated random table. Women will be asked to choose a
      sealed envelope, each envelope will contain the number allocated to the jar and special
      instructions on how to use the medication. Yasmin will be taken once daily for 21 days
      starting from the 2nd day of menstruation, Calver and placebo will be taken continuously.
      Neither the patients nor the physician will be aware of the drug used. Patients will be
      categorized in 3 groups: group1 who will receive Yasmin cyclically for 3 months (Yasmin,
      schering, cairo, Egypt) and daily oral placebo, group 2 who will receive Calver continuously
      for 3 months (Calver, Marcryl/Vertex, Cairo Egypt) and oral placebo for 21 days, group 3 who
      will receive a daily placebo and a placebo similar to COC for 21 days and will act as a
      control group.
    

Intervention name(s): Yasmin; Calver; Placebo 1; Placebo 2
Intervention type(s): Drug; Dietary Supplement; Drug; Drug
Intervention description(s): will be used every 21 days for three months by the patient; Calver will be given daily for 3 months; Patients will receive a daily placebo similar in size and structure to calvar.; Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation
Other intervention name(s): OCP; Calcium supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premenstrual syndrome; Oral contraceptive pills; Calcium Supplements
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
Condition: Flail Chest
MeSH terms: Flail Chest; Thoracic Injuries
Study type: Observational

Summary: 
      The purpose of this observational study is to document the treatment of serial rib fractures
      with MatrixRIB implants in a registry.
    

Detailed description: 
      This is a multiple site, prospective, non-randomized single arm observational study. It has
      been designed to document the treatment of serial rib fractures with MatrixRIB implants in a
      registry. A flail chest is an injury in which three or more consecutive ribs are broken. This
      injury causes a segment of the chest wall to become unstable und prevents effective
      respiration. Non-operative management requires long-term mechanical ventilation and is
      associated with a mortality rate of 17-47%. Surgical stabilization of the rib fractures has
      shown to decrease this mortality by 38% - 72%. Surgical stabilization is typically performed
      with generic plates that require extensive bending during surgery to conform the plate to the
      rib in a difficult and time-consuming procedure.

      The MatrixRIB system is the first implant system that has been specifically designed for
      fixation of flail chest injuries. It has been developed at Legacy Health System, has been
      extensively tested in biomechanical studies, and has been approved by the FDA. It provides
      anatomically contoured rib plates that can reduce the time and complexity of intra-operative
      plate contouring. These plates will be used in the present study in place of generic plates.
      It furthermore provides intramedullary rib splints that enable less invasive fixation of
      posterior rib fractures that are difficult to access for plate fixation.

      The primary objective of this study is to document stabilization of flail chest injuries with
      MatrixRIB implants in a registry. Twenty consecutive patients with flail chest injury that
      receive surgical stabilization of rib fractures with MatrixRIB implants will be documented in
      the registry. Data collected will include baseline patient demographics, and information
      related to injury severity, surgical procedures, and post-operative recovery. The patients'
      functional outcome will be assessed up to the standard follow-up visit 3 months after
      surgery.
    

Intervention name(s): MatrixRIB (FDA Approval # K081623)
Intervention type(s): Device
Intervention description(s): MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
Other intervention name(s): rib plates
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Flail chest patients admitted to Level I and Level II trauma centers.
      
Keywords: rib fracture; flail chest; plate; chest trauma; osteosynthesis; mechanical ventilation; respirator
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery
      involves creating a door in the eye wall in order to improve fluid outflow and decrease
      intraocular pressure. However, success rates range from 70% to 90% depending on the criteria
      used and tend to decrease with time. The failure of the surgery is associated with
      inflammation, new blood vessel formation and scarring which can cause closure of the door.
      Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial
      growth factor have been used successfully to decrease scarring in animal eyes where little
      doors were created and significantly improve survival. Furthermore, they have shown promise
      when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also
      been used safely in intraocular surgery to treat other diseases which involve new blood
      vessel formation such as macular degeneration and diabetes.

      The investigators hypothesize that ranibizumab may decrease the failure rate of
      trabeculectomy with mitomycin C by decreasing scarring.

      The aim of the study is to evaluate the difference in failure rates and bleb morphology at
      one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab
      in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone
      trabeculectomy with mitomycin C alone.
    

Detailed description: 
      Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma
      undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and
      September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg
      of ranibizumab (intraoperatively and on day 14) and he control group did not receive
      ranibizumab.
    

Intervention name(s): ranibizumab; standard care
Intervention type(s): Drug; Procedure
Intervention description(s): Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.; standard post-operative care after trabeculectomy with mitomycin C
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trabeculectomy; Vascular Endothelial Growth Factor A; Wound Healing; Angiogenesis Inhibitors
The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes
Condition: Sport; Supplements; Supplementation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate
      (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic
      capacity, as well as concentrations of the selected biochemical blood markers in trained
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.
    

Detailed description: 
      The effect of HMB supplementation is of great interest in sport. In view of the inconclusive
      character of the results of the studies conducted to date and of a relatively low number of
      studies investigating the effectiveness of HMB supplementation over a longer period on a
      large population of trained athletes, the aim of this study was to verify the effect of
      12-week with HMB and a placebo supplementation on body composition, anaerobic and aerobic
      capacity, as well as concentrations of the selected biochemical blood markers in trained
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.
    

Intervention name(s): β-hydroxy-β-methylbutyrate and a placebo supplementation
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: β-hydroxy-β-methylbutyric acid; Sport supplements; Training support; Adaptation
Metabolic Cost of Kettlebell Training
Condition: Exercise Energy Expenditure
Study type: Interventional

Summary: 
      This study aims at investigating the metabolic cost of several fundamental exercises with
      Kettlebell. Kettlebell training has become a popular training modality that is efficiently
      used to improve cardiovascular status and physical performance. Despite its widespread use
      and popularity the metabolic cost of exercises using kettlebell remains to be elucidated.
      Therefore, the metabolic cost of various fundamental exercise with kettlebell will be
      determined to aid the planning of exercise training programs.
    

Detailed description: 
      Ten healthy young adults will be assigned to this study. Participants will initially undergo
      a baseline assessment of their anthropometrics, body composition (by DXA), resting metabolic
      rate (RMR), cardiorespiratory fitness (VO2max), muscular strength [maximal strength (1RM) and
      muscular endurance] and functional capacity. After baseline screening, participants will
      execute in different days (one exercise per day) one set of each of the following 7
      exercises: (1) plank with kettlebell pass, (2) swings, (3) overhead squat-thrusters, (4)
      lunges with motion hands, (5) single leg deadlift, (6) wood chop και (7) snatch, in two
      different conditions: (i) 30 sec and (ii) 45 sec exercise duration, in a random order. Prior
      to each exercise resting heart rate, blood lactate concentration, oxygen consumption and rate
      of perceived exertion will be recorded. Heart rate and oxygen consumption (through portable
      gas analyzer) will be continuously monitored during the exercise and after the end of it,
      until the oxygen consumption reach the pre-exercise values (excess post-exercise oxygen
      consumption). Blood lactate and rate of perceived exertion will be reassessed post-exercise.
    

Intervention name(s): Kettlebell exercise
Intervention type(s): Other
Intervention description(s): Both arms include an exercise intervention consisted of 7 different exercises with kettlebell: (1) plank with kettlebell pass, (2) swings, (3) overhead squat-thrusters, (4) lunges with motion hands, (5) single leg deadlift, (6) wood chop και (7) snatch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Anaerobic energy expenditure; Functional training; Kettlebell training; Excess post-exercise oxygen consumption; Aerobic energy expenditure
Pediatric ASTHMA-Educator
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile
      application.
    

Detailed description: 
      This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile
      application. The study is being conducted at Montefiore Medical Center among pediatric (7-17
      years old) patients with persistent asthma. We are collecting process and clinical outcomes
      in a longitudinal study design.
    

Intervention name(s): Pediatric ASTHMA-Educator mobile application
Intervention type(s): Other
Intervention description(s): This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.
Intervention model: Single Group Assignment
Intervention model description: There is one group (intervention arm only) in this proof of concept study.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: asthma
Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      MR Elastography is a new technique aimed at non-invasively measuring the stiffness of
      tissues. It has recently given interesting results in the assessment of liver fibrosis.

      The objectives of the current study are:

        1. to develop an imaging protocol for MR Elastography of the kidneys;

        2. To calculate the stiffness of normal kidneys;

        3. To evaluate the variability of the measurements of kidney stiffness by repeating the
           procedure twice on the same volunteers.
    


Intervention name(s): Pneumatic Driver
Intervention type(s): Device
Intervention description(s): Ten healthy volunteers will undergo MR Elastography using a pneumatic driver connected to a commercially available speaker and the stiffness of the left kidney will be measured.
The examination will be repeated on the same volunteers at least one month later and the same stiffness measurements will be performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MR Elastography; kidney; fibrosis
Effects of Learning and Food Form on Intake in Humans
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Due to the rising incidence of obesity, much emphasis has been placed on identifying
      mechanisms of increased energy intake. At this point, the mechanisms responsible for the
      recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive
      influences, such as cognitive factors, may play a larger role in creating an energy surplus
      than previously thought. Expectations about the satiating effect of a food may override the
      post-ingestive influences in dictating further consumption. In addition, obese individuals
      may exhibit a decreased compensatory response to foods as compared to lean individuals.

      Understanding the effects of energy content, food form, and learning on satiation, satiety,
      and energy intake will allow for a greater understanding of the mechanisms of energy
      imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive
      effects. By utilizing foods with similar sensory properties, the acquired knowledge derived
      from ingesting these foods can be monitored by analyzing subsequent intake at the same meal
      and at subsequent eating occurrences. It is hypothesized that the liquid food form will
      elicit weaker dietary compensation; that is, energy intake at other eating events will not be
      adjusted to compensate for that food. In addition, it is posited that the lower energy food
      will cause lower compensation postprandially. By having participants consume the same test
      food daily over a two week learning period, it is thought that they will show improved
      dietary compensation when the initial testing is repeated due to learned associations between
      food properties and metabolism.
    

Detailed description: 
      No expansion provided.
    

Intervention name(s): Metabolic effects of consuming energy dense beverages; energy dense solid food; Energy dilute beverages; Energy dilute solid food
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Consumption of energy dense beverages for 2 weeks and monitoring physiological responses; Effects of consuming energy dense solid food for two weeks on physiological responses; Effects of consuming energy dilute beverages for two weeks on physiological responses.; Effects of consuming energy dilute solid food for two weeks on physiological responses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: obesity; energy intake; appetite; food form; beverage; learning; dietary compensation