bioihbjkbjnl/mcl2 huggingface dataset:
Endometrial Injury in Women With Unexplained Infertility
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Women between 18-39 years old who had been infertile (primary or secondary) for at least 1
      year were recruited. In a parallel assignment eligible participants were randomized to
      receive either a single, site-specific endometrial injury guided by hysteroscopy (Study
      group) or no intervention (Control group). Natural cycle folliculometry + timed sexual
      intercourse were offered for all participants for the ongoing and the immediate 2 concecutive
      cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the
      secondary outcome measures.
    

Detailed description: 
      A single site-specific hysteroscopic injury procedure (Snip) will be performed using an
      office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow
      diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal
      with normal saline as distension medium, with flow manually regulated through the key of the
      hysteroscopic sheath.

      The examination of the uterine cavity begins by observing its regularity, paying special
      attention to the presence of intrauterine malformations or morphologic alterations such as
      submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a
      2.2 mm working channel, and will be used to generate a local injury on the upper posterior
      endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing
      menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single
      bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after
      the procedure.

      Natural cycle folliculometry + timed sexual intercourse will be offered for all participants
      for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will
      reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.
    

Intervention name(s): Endometrial injury
Intervention type(s): Procedure
Intervention description(s): Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Antiviral Therapy on HBV Reactivation
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related
      hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA .
      The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA
      negative HBV-related HCC are unclear.
    

Detailed description: 
      Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related
      hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA .
      The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA
      negative HBV-related HCC are unclear.From July 2012 to December 2015, 174 consecutive
      patients with serum HBV-DNA negative HBV-related HCC underwent resection were prospectively
      enrolled in the studied. There are 66 patients received preoperative antiviral therapy
      (antiviral group) and 108 patients did not receive any antiviral therapy (non-antiviral
      group). The incidence of HBV reactivation, risk factors of liver function were analyzed in
      perioperative period. HBV reactivation developed in 30 patients (27.8%) in the non- antiviral
      group and 2 patients (3.0%) in the antiviral group, respectively (P < 0.001). Multivariate
      analysis revealed that minor hepatectomy (HR, 4.695; 95% CI, 1.257-17.537, P = 0.021) and
      without antiviral therapy (HR, 8.164; 95% CI, 1.831-36.397, p =0.006) were risk factors
      attributed to HBV reactivation. Patients in antiviral group and non-antiviral group or
      reactivation group and without reactivation group have similar ALT, TBil, ALB, and PT in 7
      days after resection. However, patients in antiviral group have significantly better ALT and
      ALB on day 30th after resection than those in control group. Moreover, similar phenomenon
      were observed when comparing those with or without HBV reactivation. Resection could lead to
      HBV reactivation during the perioperative period for serum HBV DNA negative HBV-related HCC,
      especially in patients who did not receive any antiviral therapy. Anti-HBV therapy can reduce
      the risk of reactivation, thus improving liver function after hepatectomy.
    

Intervention name(s): Entecavir therapy
Intervention type(s): Drug
Intervention description(s): Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.
Intervention MeSH terms: Entecavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Patients with breast cancer undergo a series of psiclofisicas alterations during cancer
      treatment, chemotherapy phase being one of the more aggressive ete effect. These changes
      reduce the quality of life and result in a loss of physical health-related condition. Studies
      have shown that the practice of physical exercise and rehabilitation strategies enhance or
      attenuate the impact of chemotherapy on quality of life of patients. At present,
      technological development from telerehabilitación systems is a promising strategy that
      enables fast and efficient communication between health professionals and patients,
      especially at this stage of the disease where the patient may encounter difficulties in
      matching measures improving their lifestyle with aggressive medical treatment.

      To carry out this study a controlled study masked, parallel-group done were conducted usual
      care control group and an intervention based on a web system telerehabilitación to improve
      the physical condition associated with health and performed quality of life.
    

Detailed description: 
      The CUIDATE group will identify impairments of participants at baseline assessment. The aims
      based on weekly improvements will be set to facilitate the final goal. After each training
      session there will be feedback between the participant and the CUIDATE group to change or
      improve any exercise or activity. This feedback will allow to us to select adequate exercises
      and levels of difficulty. As a result, a modifiable personal training will be assigned to
      each one focusing on cardio-respiratory, mobility, and endurance performance through online
      system rehabilitation (using written instructions, HD videos, and audio files).
    

Intervention name(s): Telerehabilitation eCUIDATE system
Intervention type(s): Device
Intervention description(s): Resistence and endurance exercise adapted to individual requeriment during chemotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: breast cancer; telerehabilitation; strength; fatigue; quality of life
Effects of a Warm-up on Immune Response to Exercise
Condition: Physiological and Psychological Responses to Exercise
Study type: Interventional

Summary: 
      This randomized cross-over study compares two identical cardiorespiratory exercise bouts,
      differing only in the inclusion or exclusion of a dynamic period of increasing exercise
      intensity prior to the exercise bout. Planned comparisons include physiological responses and
      perceived effort during exercise, leukocyte mobilization, and mood between the two exercise
      sessions.
    

Detailed description: 
      Physically active adult men and women are asked to complete three study visits to the
      laboratory. On Visit 1, participants provide informed consent and are screened for study
      inclusion criteria: being between 18 and 40 years of age, a non-smoker, not pregnant, free of
      disease impacting exercise performance or immunity, and performing at least one hour per week
      of vigorous exercise training (any modality) for at least the prior six months. Participants
      also complete an incremental submaximal exercise test on a stationary bicycle. The results of
      this test are used to calculate the resistance corresponding to 80% of estimated maximal
      heart rate. Participants return within 2-14 days for Visits 2 and 3. These visits consist of
      30 min of bicycling at this resistance. One visit included a 10 min dynamic warm-up prior to
      the exercise bout. Participants were stratified by sex and randomized such that half of the
      men and women completed the exercise trial with warm-up during Visit 2.

      Heart rate, perceived exertion, and wattage are recorded during each minute of the exercise
      bouts. Participants donate blood before, immediately after, and 1h after each exercise. Blood
      is analyzed by flow cytometry to characterize leukocyte subsets. After each exercise session,
      participants complete surveys assessing mood and affect.

      Physiological, immunological, and psychological parameters recorded will be compared within
      participants between the two experimental exercise sessions using appropriate statistical
      tests. p<0.05 will be accepted as significant.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 30 minutes of exercise at 80% of maximum predicted heart rate performed on an indoor stationary bicycle. Exercise was preceded by 10 min of gradually increasing cycling intensity in one of two exercise trials
Other intervention name(s): Cardiorespiratory exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over study with two conditions. Randomization was stratified by sex
Masking: None (Open Label)
Primary purpose: Basic Science
Utilizing Hyperpolarized 129Xe Magnetic Resonance Imaging in Children With Primary Ciliary Dyskinesia
Condition: Primary Ciliary Dyskinesia
MeSH terms: Ciliary Motility Disorders; Dyskinesias
Study type: Observational

Summary: 
      This study investigates the use of hyperpolarized 129Xe magnetic resonance imaging (MRI) in
      children with primary ciliary dyskinesia (PCD) in detecting ventilation defects. The
      investigators will establish the feasibility and reliability of this test and how it changes
      compared to other pulmonary function tests.
    

Detailed description: 
      Primary Ciliary Dyskinesia (PCD) is an autosomal recessive inherited disorder caused by
      defects in ciliary structure and/or function. Prevention or delaying disease progression
      requires medical therapies and routine lung function monitoring, with the goal of early
      initiation of medical therapies. Of course, this is contingent on recognizing early lung
      disease.

      Current investigations for monitoring lung disease include pulmonary function tests (PFT),
      chest x rays and chest CTs. But each of these modalities are either not sensitive enough or
      expose the patient to ionizing radiation.

      The investigators believe that hyperpolarized 129Xe MRI (HP Xe-MRI), new imaging modality,
      will be more sensitive then current tests and also avoid the need for ionizing radiation. To
      evaluate this, The investigators will compare HP Xe-MRI to PFT, when the patient is well and
      during a pulmonary exacerbation that is being treated.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 6-18 with primary ciliary dyskinesia
      
Keywords: Xenon MRI; Lung; Pulmonary Exacerbation
Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study was to compare the long-term oncology outcomes and specimen quality
      of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort.
      At the same time, the local recurrence following a primary rectal cancer resection was
      analyzed to respond to the concerns about the event of the national suspension for TaTME due
      to the high local recurrence rate in Norway.
    

Detailed description: 
      Laparoscopic surgery is considered to have better visualization for more accurate separation
      and further injury reduction than open surgery. However, the oncology outcomes are still
      controversial. Especially in the challenging patients who have narrow and deep pelvic, the
      disadvantage that it is difficult to obtain high-quality resected specimens during
      laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal
      total mesorectal excision (taTME) is an alternative method to solve this "old problem".
      However, as a new technology that has been around for only 10 years, the applicability of
      taTME worldwide needs to be further proved in long-term oncology. This prospective cohort
      study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on
      long-term oncology outcomes from a single, experienced Chinese center that was an early
      adopter of taTME.
    

Intervention name(s): transanal total mesorectal excision
Intervention type(s): Procedure
Intervention description(s): transanal TME
Other intervention name(s): laparoscopic total mesorectal excision
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Low-mid rectal cancer within Stage III.
      
Keywords: Rectal cancer; taTME; Local recurrence
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude
Condition: Altitude Hypoxia
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating the effect of acetazolamide on postural
      control in lowlanders older than 40 years travelling from 760 m to 3'100 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of preventive acetazolamide intake on the postural control in lowlanders older than 40 years
      travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be
      transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there
      for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at
      760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

      An interim analysis will be carried out when 80 participants will have completed the study or
      after the first year. The Peto's method will be used and the trial will be stopped when
      pre-specified futility boundaries were crossed.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: healthy participants older than 40 years; postural control; prevention; acetazolamide
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Condition: Safety and Tolerability of EGT0001474 in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety, tolerability and pharmacokinetics of single or multiple
      doses of EGT0001474.
    

Detailed description: 
      EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being
      developed for the treatment of Type II Diabetes mellitus.

      This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of
      single and multiple ascending doses of EGT0001474 in healthy male and female subjects.

      In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or
      placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of
      EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were
      analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious
      adverse events, mild adverse events were observed.

      This study provided information on human safety, tolerability, PK and pharmacodynamic effects
      of EGT0001474.
    

Intervention name(s): EGT0001474; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral ascending doses given daily as capsules for up to 14 days; Placebo to match EGT0001474
Other intervention name(s): Human SGLT2 inhibitor; Human SGLT2 inhibitor
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2
Vascular Subphenotypes of Lung Disease in HIV & COPD
Condition: Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Observational

Summary: 
      This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension
      PAH) in HIV and COPD patients.
    

Detailed description: 
      The goal of the project is to identify and characterize populations at risk for developing
      pulmonary arterial hypertension (PAH). The project will establish a PAH subphenotype core
      cohort (CORE) to evaluate mechanistic pathways and test novel therapeutic agents. This core
      cohort serves as a resource for the Translational Program Project grant, Vascular
      Subphenotypes of Lung Disease (Mark Gladwin, PI). In order to construct the CORE, we have
      chosen to recruit COPD and HIV patients, two populations with advanced lung and systemic
      diseases that are enriched for PAH. We have selected these as prototypic conditions because:
      A) both COPD patients and HIV-infected patients develop PAH at a rate significantly greater
      than the general population, B) morbidity and mortality are greatly increased in
      dually-affected persons, C) mechanisms responsible for development of the PAH "subphenotype"
      are not well-understood, D) clinical and genetic characteristics of the subgroup with PAH are
      not known, and E) effects of PAH therapies in subphenotypes are incompletely studied. There
      is also some overlap between COPD and HIV, with HIV-infected patients having accelerated COPD
      even with effective antiretroviral therapy. Participants with COPD, HIV, or HIV-uninfected
      controls will be recruited to the study based on entry criteria of elevated N-terminal
      pro-brain natriuretic peptide (NT-proBNP) and/or an abnormal echocardiogram. These subjects
      will then undergo a 6-minute walk test, blood collection, questionnaire, medical record
      review, and echocardiography (if not previously performed). Selected subjects will then be
      recruited to undergo right heart catheterization. The goals of the study are to establish a
      pulmonary hypertension cohort for translational investigations, to determine the utility of
      NT-proBNP as a biomarker of PAH, to determine clinical characteristics and relationship of
      lung function to PAH in COPD and HIV, and to establish a biorepository for mechanistic
      studies of PAH phenotypes.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pitt mens Study(MACS).

        University of Pittsburgh HIV Clinic(PACT).

        Emphysema COPD Research Center Research Registry(ECRC).

        University of Pittsburgh Medical center pulmonary hypertension clinic
      
Biospecimen description: 
      Whole Blood
    
Keywords: HIV; COPD; Pulmonary disease
Synchronizing Blastocyst in Frozen Embryo Transfer
Condition: Embryo Implantation
Study type: Interventional

Summary: 
      The aim of the present study is to determine if implantation rate could be increased in women
      undergoing frozen embryo transfer cycles in case of adjusting their embryo development at
      hatching stage.
    


Intervention name(s): synchronizing blastocysts
Intervention type(s): Other
Intervention description(s): transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Efficacy of Postural Reeducation in Elite Gymnasts With Back Pain
Condition: Back Pain; Back Strain Lower Back; Athletic Injuries
MeSH terms: Back Pain; Athletic Injuries
Study type: Interventional

Summary: 
      Introduction: Low back pain is a musculoskeletal disorder that is associated with symptoms
      such as pain, limitation of joint range and postural problems in athletes. Methods: The study
      design is a randomized controlled clinical trial with a minimum of 35 elite gymnasts with
      back pain. Two postural treatments will be implemented, Mezieres Method and Isostretching to
      verify if there is improvement of back pain in gymnasts and to compare both procedures.
      Discussion: This trial could generate a greater understanding of the importance of posture
      related to low back pain and its possible treatments.
    

Detailed description: 
      A randomized controlled clinical trial with two groups (intervention and placebo) will be
      implemented. The intervention group will have the Mezieres technique as postural treatment
      while the placebo group will follow a total of 6 isostretching positions.

      In total, the two treatments with 30 minutes and duration or with a frequency of 2 weekly
      sessions will be implemented for a period of 12 weeks. All treatments will be performed by
      the same certified therapist and with a minimum of 5 years of experience in postural
      treatments. The measurements will be made immediately after the first session, in 2 weeks, 6
      weeks and in the last week of intervention by a blind researcher who did not participate in
      the treatments, but with experience in this field.
    

Intervention name(s): Mezieres Postural Treatment
Intervention type(s): Other
Intervention description(s): Implementation of 12 weeks suitable postures of Mezieres method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Rehabilitation; Treatment; Isostretching; Postural treatment