bioihbjkbjnl/mcl2 huggingface dataset:
Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is
      administered to trigger the final follicular maturation before oocyte retrieval, in an
      attempt to mimic the physiologic effects of LH. The hCG is administered when more than three
      follicles ≥17mm in mean diameter have developed.

      The time interval between hCG administration and oocyte retrieval is of critical importance
      since the time after luteinizing stimulus is a period of intense processes including the
      start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.

      The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to
      avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown
      that significantly more high quality embryos have been obtained with a prolonged
      hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be
      beneficial in improving oocyte quality and achieving optimal maturation.

      Currently there are no data on the effect of the time interval between hCG administration and
      oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to
      determine whether there is any difference in in vitro fertilization outcome when oocyte
      retrieval takes place at 36 h or 38 h following hCG administration
    


Intervention name(s): Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Intervention type(s): Procedure
Intervention description(s): Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Other intervention name(s): oocyte retrieval at 36 hours following hCG administration; oocyte retrieval at 38 hours following hCG administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF, hCG, oocyte retrieval, time interval
Reconstructing Consciousness and Cognition
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Currently it is unknown how the human brain reorganizes its network organization to generate
      conscious experience and cognitive activity after a period of unconsciousness. Therefore, the
      purpose of this study is to assess how cognitive activity is reconstructed after general
      anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to
      consciousness and full cognition is a complex process that occurs over an extended period of
      time. Specifically, the investigators hypothesize the following order of cognitive
      reconstitution: responsiveness to command, attention, complex scanning and visual tracking,
      working memory, and executive function.

      Volunteers will be healthy participants who are anesthetized with commonly used anesthetic
      drugs as well as a non-anesthetized group to control for circadian influences. A total of 60
      subjects will be recruited for this study. All subjects (male and female) will perform basic
      tests for cognition on a laptop computer at 30-minute intervals during this study. The
      testing battery to be administered was assembled to assess multiple cognitive functions in
      order to determine whether and how cognitive processes return to baseline function.
      Electroencephalogram (measuring brain electrical activity) data will be monitored and
      recorded during both anesthesia and cognitive testing, for subsequent analysis.

      This study is significant because it could lead to a better understanding of the neural
      correlates of human consciousness, as well as normal and abnormal conscious state transitions
      (including barriers to such transitions).
    


Intervention name(s): ISOFLURANE- Experimental Arm; Control Group: Cognitive Testing
Intervention type(s): Drug; Other
Intervention description(s): The experimental group will be given the anesthetic isoflurane for three hours, and will undergo cognitive tests immediately following emergence from general anesthesia while connected to an EEG machine.; The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.
Intervention MeSH terms: Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: General anesthesia; cognition; consciousness
Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of and immune response to an alphavirus
      replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States,
      South Africa, and Botswana.
    

Detailed description: 
      HIV-1 subtype C is the prevailing subtype of HIV found in sub-Saharan Africa and is primarily
      responsible for the HIV/AIDS epidemic in southern Africa. Thus, development of a preventive
      subtype C vaccine is critically important in controlling the spread of HIV in this part of
      the world. This study will determine the safety and immunogenicity of an alphavirus replicon
      HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults. This vaccine utilizes a
      propagation-defective replicon vector system derived from an attenuated strain of Venezuelan
      Equine Encephalitis (VEE) virus. The vaccine replicon expresses the gag gene from a South
      African subtype C isolate of HIV-1. Participants will be recruited in the United States,
      South Africa, and Botswana.

      The study will last for 1 year. Participants will be enrolled sequentially, from lowest to
      highest dose of vaccine, into one of four groups. Groups will begin enrollment only following
      safety review of the previous group. Participants will be randomly assigned to receive active
      vaccine or placebo. During the study, participants will receive either 3 injections of one of
      four possible doses of the vaccine or 3 injections of placebo. Injections will be given at
      study entry and at Days 28 and 84. At screening, participants will undergo medical history
      assessment, a complete physical, HIV testing and counseling, and blood and urine collection;
      they will also be interviewed and asked to complete a questionnaire. After screening, there
      will be 8 study visits; the visits will occur at Days 14, 28, 42, 84, 98, 168, 273, and 364.
      Participants will be interviewed and asked to fill out a questionnaire at each study visit;
      participants will undergo a physical, additional HIV testing and counseling, and blood and
      urine collection at selected visits.
    

Intervention name(s): AVX101; placebo
Intervention type(s): Biological; Other
Intervention description(s): Alphavirus replicon particle vaccine expressing HIV Gag antigen; phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The main objective of the study is to investigate the correlation between the measurement of
      the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface
      topography.

      The device used in this research to the topography examination is three-dimensional
      morphometry device of AXS Medical society : the BIOMOD L.
    

Detailed description: 
      For usual follow-up visit, patients will have a x-ray examination of the spine and the
      surface topography. The measurement of the angle of scoliosis is achieved by two independent
      operators for both methods.

      Patients then have a follow-up visit at 6 and 12 months.
    

Intervention name(s): Use of Biomod device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: topography; cobb angle
Rehabilitation Programs After Achilles Tendon Rupture
Condition: Rupture of Achilles Tendon; Immobility Response, Tonic; Rupture, Spontaneous
MeSH terms: Rupture, Spontaneous; Rupture
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of early mobilization versus traditional
      immobilization rehabilitation programs after surgical Achilles tendon repair on the
      mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular
      activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis
      morphology (muscle architecture), functional performance, and the mechanical and material
      properties (force-elongation and stress-strain relationships) of the injured and uninjured
      Achilles tendon.

      The hypothesis is that the early mobilization could reduce the deleterious effects of the
      joint immobilization and improve the tendon healing.
    

Detailed description: 
      Participants were allocated into one of two intervention groups (traditional immobilization
      or early mobilization).

      Traditional immobilization group (45 days of plaster cast immobilization; after the
      immobilization period, subjects received instructions on how to perform a home-based exercise
      program)

      Early mobilization (six weeks of physical therapy program; three times per week; one to two
      hours of exercises for regaining range of motion and muscular endurance)

      Control group (subjects had no history of lower limb injury, and were matched in age and
      anthropometric measurements to subjects that performed physical rehabilitation and to
      subjects that remained immobilized.
    

Intervention name(s): Traditional Immobilization; Early Mobilization
Intervention type(s): Other; Other
Intervention description(s): After surgery subjects were immobilized in a plaster cast, with the ankle positioned in gravitational equinus; weight bearing was not allowed. Two weeks post-operatively, the cast was removed and the patient was immobilized with a new plaster cast, with the ankle in the same position. Four weeks post-operatively, the ankle was plastered in neutral position (i.e. with the sole of the foot perpendicular to the shank), and weight bearing was encouraged. Six weeks post-operatively, the plaster cast was removed
The home exercise program consisted of active exercises and stretches to improve ankle range of motion, and resistance and balance exercises; The physical therapy started two weeks after the surgery and lasted six weeks, during which a removable brace was used. Therapy sessions, three times per week in the six-week period, included one to two hours of exercises for regaining range of motion and muscular endurance.
Other intervention name(s): Plaster cast immobilization; Accelerated rehabilitation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achilles tendon rupture; Rehabilitation; Immobilization; Muscle architecture; Functionality; Neuromuscular parameters; Weight-Bearing
Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral
      doses of probucol in healthy male subjects.
    

Detailed description: 
      This is a single dose, single period, multiple administration, open-labeled trial in one
      investigation center.

      The screening examination will be completed from Day -14 to Day -2 before investigational
      medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day
      1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive
      days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up
      visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.
    

Intervention name(s): Probucol
Intervention type(s): Drug
Intervention description(s): 250mg (1 tablet) bid. p.o for 14 consecutive days
Other intervention name(s): Lorelco
Intervention MeSH terms: Probucol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pharmacokinetics; Probucol; healthy male subjects
Hypnosis, Self-hypnosis and Weight Loss in Obese Patients
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      High food impulsiveness, impaired food reward and stress response are involved in the
      phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a
      complementary medicine which is recognized as effective for defined indications. Complexity
      and diversity of methodological studies with hypnosis does not allow to conclude on its
      efficacy in treating this disease.

      In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and
      self-hypnosis practice would improve food disinhibition assessed by an adapted questionary
      (TFEQ 51).
    

Detailed description: 
      Obese failing patients are recruited in an university hospital. Half of the subjects will be
      randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food
      impulsivity and specially disinhibition. In the same time, all the included patients will
      follow therapeutic workshops based on current recommendations of the High Health Authority of
      France (HAS) for physical activity and the dietetic.

      In the hypnosis group, eight workshops are planned during six months. Furthermore, patients
      have to practice daily self-hypnosis. In the same time, all the patients included will
      participate in eight dietetic workshops.

      It is expected an improvement in patient involvement in personalized care plan, that eating
      behavior is more suited and consequently a significant decrease in weight.
    

Intervention name(s): dietetic counselling; Hypnosis and self-hypnosis
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Erickson's hypnosis and self-hypnosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypnosis; self-hypnosis; obesity; high food impulsiveness
Reproductive Outcome in Assisted Conception Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Infertility is the failure to conceive after regular unprotected sexual intercourse for one
      year. Primary infertility refers woman who has never conceived, and secondary infertility to
      one who has had a previous pregnancy.The most frequent causes for infertility are ovulatory
      disorder or anovulation (27-30%) , tubal factor(20-22%), abnormal semen parameters(45-50%).
      Unexplained infertility refers to infertile couples in whom standard investigations,
      including tests of ovulation, tubal patency tests and semen analysis are normal. incidence
      15-17% of infertile couples. New guidelines on infertility recommend that women with
      unexplained infertility should be advised for expectant management for 2 years .If pregnancy
      is not achieved after this period In vitro fertilization Should be considered. The Fast Track
      and Standard Treatment trial demonstrated A shorter time to pregnancy and higher per cycle
      pregnancy rates for In vitro fertilization compared with treatment with oral agents or
      gonadotropins in Patients with unexplained infertility. Successful pregnancy after assisted
      reproductive technology is influenced by numerous predictors that have been investigated in
      the previous years. The central predictors of success are the sperm, oocyte quality and
      endometrial receptivity. Oocyte quality depends mainly on the age of the woman , and her
      ovarian reserve. Parameters most commonly studied are the woman's age , her antral follicle
      count , and laboratory tests including serum randomly done during the menstrual cycle levels
      at day 3 of the cycle.
    


Intervention name(s): follicular stimulating hormone; Anti-mullerian hormone; Basal antral follicle count
Intervention type(s): Diagnostic Test; Diagnostic Test; Radiation
Intervention description(s): in the serum of our patients; in the serum of our patients; by ultrasound
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on
      the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus
      (T2DM).
    

Detailed description: 
      The primary objective of this study is as follows:

      • To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady
      state pharmacokinetics (PK) of metformin in subjects with T2DM.

      The secondary objectives of this study are as follows:

        -  To examine the safety and tolerability of metformin when co administered with ranolazine
           500 mg bid at steady-state in subjects with T2DM.

        -  To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM
           receiving metformin.
    

Intervention name(s): Metformin; Ranolazine
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 1000 mg bid on Days 1-10; Ranolazine 500 mg bid on Days 6-10
Other intervention name(s): Glucophage; Ranexa
Intervention MeSH terms: Metformin; Ranolazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Metformin; Ranolazine; Type 2 Diabetes Mellitus
Quality of Life After Denture Relining
Condition: Quality of Life
Study type: Interventional

Summary: 
      Purpose: the aim of the present study was to analyze the impact of mandibular denture
      relining with soft or hard denture liners in the oral health related quality of life (OHRQoL)
      of edentulous patients.

      The null hypothesis was that there would be no difference in OHRQoL findings after mandibular
      denture relining between patient groups treated with hard or soft denture liners.
    

Detailed description: 
      Complete denture wearers had their existing mandibular dentures relined with a soft
      silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based
      denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT
      (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures
      (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were
      proposed for each question: never (0), sometimes (1) and almost always (2). Results were
      analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0
      and T90) and group (hard and soft denture liners).
    

Intervention name(s): Denture liner Mucopren Soft; Group 1; Denture liner Kooliner; Group 2
Intervention type(s): Other; Other
Intervention description(s): Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22); Complete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.
Other intervention name(s): Mucopren Soft relining; Kooliner
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: edentulism; denture liner; prosthodontics; OHIP EDENT
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Condition: Stomach Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Phase II:

      Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with
      cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III
      survival comparison against the CDDP + 5-FU control arm.

      Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2
      test groups.

      Phase III:

      Primary objective: to detect a statistically significant increase in time to progression
      (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm
      (cisplatin plus 5-FU).

      Main secondary objective: to detect a statistically significant increase in overall survival
      (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm
      (cisplatin plus 5-FU).

      Other secondary objectives: to compare response rates, time to treatment failure, duration of
      response, safety profiles, quality of life and disease-related symptoms.Socio-economic data
      will be collected in order to be able to perform an analysis by country when necessary.
    


Intervention name(s): XRP6976
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: docetaxel; stomach neoplasm