bioihbjkbjnl/mcl2 huggingface dataset:
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Condition: Endometriosis; Endometriosis Ovary; IVF
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      It is generally assumed that the major causes of in vitro fertilization (IVF) failure in
      women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and
      low quality of embryos. The use of prolonged courses of hormone therapy may play an important
      role in the strategy of overcoming endometriosis-related infertility. The aim of this study
      was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis
      undergone a previous IVF failed cycle
    

Detailed description: 
      The primary outcomes of the study are clinical pregnancy rate and live birth rate after
      reaching 24 week's gestation.

      Secondary outcomes of the study are: changes in the diameter and volume of the largest
      endometrioma, total gonadotropin dose administered, number of mature oocytes collected,
      number of two-pronuclear (2PN) embryos, number of blastocysts.
    

Intervention name(s): Dienogest 2 MG
Intervention type(s): Drug
Intervention description(s): Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF
Intervention MeSH terms: Dienogest
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with endometriosis who previously failed one IVF cycle and all resultant frozen
        embryo transfer
      
Keywords: endometriosis; IVF
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.
Condition: Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
MeSH terms: Fatigue Syndrome, Chronic; Myalgia; Brain Diseases; Encephalitis; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic
      Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from
      B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and
      maintenance treatment.
    

Detailed description: 
      We have published a case series of pilot patient observations with B-cell depletion in
      Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) (Fluge and Mella, BMC Neurol,
      2009). Subsequently, we published a small randomized and double-blind phase II study using
      rituximab induction two infusions two weeks apart (Fluge et al, Plos One, 2011).

      We have completed an open label phase II study with 29 patients using rituximab induction and
      maintenance treatment (six rituximab infusions over 15 months, with follow-up for three
      years, unpublished).

      We hypothesize that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic
      Encephalopathy (CFS/ME) have a chronically activated immune system involving B-lymphocytes,
      possibly a variant of an autoimmune disease, and that patients may benefit from B-cell
      depletion therapy.

      Three substudies will be performed:

      Endothelial function: assessment of Flow-Mediated Dilation and skin microcirculation at
      baseline and repeated during the time interval 17-21 months.

      Cardiopulmonary exercise test for two following days: assessment at baseline and repeated
      during the time interval 17-21 months.

      Gastrointestinal function: assessment at baseline and repeated during the time interval 17-21
      months.
    

Intervention name(s): Rituximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).
Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months.; Saline (NaCl 0,9%) added human albumin (Flexbumin) 0,4 mg/ml, two infusions two weeks apart. Maintenance infusions after 3,6, 9 and 12 months.
Other intervention name(s): Rituxan; Mabthera; Saline
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome (CFS); Myalgic Encephalitis (ME); Rituximab; B-lymphocyte depletion; B-cell depletion
Coagulopathy and SIRS During ECC in Intensive Care
Condition: Disorder of Circulatory System
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      This observational clinical study investigates cellular and plasmatic activation markers as
      well as proteins involved in coagulation and inflammation in patients being connected to
      different extracorporeal circulation (ECC) and circulatory support devices under intensive
      care conditions.
    

Detailed description: 
      The complex interplay between the various factors contributing to the ECC-related
      coagulopathy and inflammation in intensive care settings is only poorly understood so far.
      Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which
      anticoagulants may be employed to decrease complications associated with specific ECC
      systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy
      varies between different ECC systems and intensive care units.

      A better understanding of the mechanisms of the activation and interaction of platelets and
      leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight
      starting-points to increase the safety and efficacy of ECC in intensive care medicine. The
      investigation of these phenomena in different ECC systems under clinical conditions is
      therefore the goal of this study.

      In order to achieve the study goal, we will investigate cellular and plasmatic activation
      markers as well as proteins involved in coagulation and inflammation in patients being
      connected to different ECC systems under intensive care conditions.
    

Intervention name(s): ECLS/ECC
Intervention type(s): Device
Intervention description(s): Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Patients undergoing implantation of extracorporeal circulation or mechanical
             circulatory support systems (ECLS / ECMO / LVAD / dialysis) due to cardiac failure, or
             lung failure, or renal failure, or a combination of these diseases.

          -  Patients undergoing cardiac surgery with extracorporeal circulation (ECC).
      
Biospecimen description: 
      human whole blood and blood plasma
    
Keywords: Extracorporeal circulation, ventricular assist device
Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts
Condition: Healthy Subject
Study type: Interventional

Summary: 
      The objective of this study is to assess bioavailability of total gingeroids, free gingerols
      and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after
      consumption of a single dose of 5 different ginger extracts. These five extracts have the
      same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26%
      NOP80).
    


Intervention name(s): Tested product n°1; Tested product n°2; Tested product n°3; Tested product n°4; Tested product n°5
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic); 1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic); 2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic); 1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic); 6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
Other intervention name(s): Gingest TM 26% 28.9 mg; Oleoresin 39% 28.9 mg; Ginger 5% 28.9 mg; Gingest TM 26% NOP80 28.9 mg; Ginger 1.6% 28.9 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ginger; Pharmacokinetics; Shogaols; Gingerols; Bioavailability
A Facebook-based Weight Loss Programme for Obese Adults in Hong Kong
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and efficacy of a 6-month weight
      loss intervention program for obese working adults through a popular social networking site -
      Facebook.
    

Detailed description: 
      Obese individuals often are at higher risk for developing non-communicable diseases such as
      diabetes and cardiovascular disease. The regular physical activity, healthy diet and social
      support have been shown to be beneficial for weight loss.

      This is a two-arm parallel design randomized controlled trial for 6 months. Participants who
      completed the baseline assessment will be randomly allocated, after stratified by gender, to
      either a control group or Facebook-based intervention group. The control group will receive
      information on healthy eating, physical activity, obesity and cancer via three government
      printed health pamphlets. In addition to the government health pamphlets, the intervention
      group will receive a programme delivered through Facebook.

      The interventions include participation in a private research group on Facebook for health
      education, self monitoring and social support. Participants will receive 12 weekly lessons
      related to nutrition, physical activity, Chinese food therapy, acupressure, weight loss. A
      registered nutritionist and a registered Chinese medicine practitioner will join the Facebook
      group as health partners. Both of them are also registered nurses.

      Data collection will be carried out at baseline, 3 months and 6 months. Each time, both
      groups will complete online questionnaires and attend in-person anthropometric measurements
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): East-meets-West Lifestyle Intervention elements include nutrition and exercise from the Western perspective, food therapy and acupressure from the Traditional Chinese Medicine perspective, self-monitoring, and motivational videos of successful stories from working colleagues. The group participants in the Facebook are encouraged to post their health behaviors and questions, self-monitor, pledge for weight loss, seek social support and interact with health partners and other participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chinese population; acupressure; physical activity; nutrition; Facebook
Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
Condition: Postural Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Interventional

Summary: 
      This study is to determine different chemical levels in the blood during a low salt diet.
      This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)
    

Detailed description: 
      Patients with postural tachycardia syndrome had a subnormal increment in aldosterone with
      upright posture, which might reflect a blunted adrenal response to stimulation upon assuming
      upright posture. In this AIM, we propose to assess the adrenal response to aldosterone
      stimulation with intravenous adrenocorticotropin hormone.

      For this protocol, subjects enrolled in the parent study will be approached about this
      sub-study. Subjects will be assured that they are not required to participate in this study
      even if they choose to participate in the parent study.

      There will be no randomization for this specific sub-study. The order of diets (low sodium
      vs. high sodium) will be performed as a part of the parent study, and not as a part of this
      sub-study. This sub-study will only be performed in the LOW dietary salt phase.

      All subjects will be previously screened and evaluated as a part of the parent study. No
      further screening will be performed exclusively for this study. Women of childbearing
      potential will have had a serum pregnancy test as a part of the parent study. Pregnant women
      will not be allowed to participate.
    

Intervention name(s): Cosyntropin administration
Intervention type(s): Drug
Intervention description(s): After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
Other intervention name(s): Cortrosyn
Intervention MeSH terms: Cosyntropin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: POTS
A Fighting Chance: Pilot Study of a Group Mentoring Intervention for Assault Injured Youth
Condition: Violence
Study type: Interventional

Summary: 
      This pilot study is a randomized controlled trial in which assault-injured 12-14 year old
      youth recruited from the emergency department (ED) are randomly assigned to standard care or
      "A Fighting Chance" group mentoring.
    

Detailed description: 
      The goal of this project is to adapt, implement and evaluate Take Charge! (a 1:1 mentoring
      intervention for assault-injured youth) for a group mentoring model.

      This pilot study is a randomized controlled trial in which assault-injured 12-14 year old
      youth recruited from the emergency department are randomly assigned to standard care or "A
      Fighting Chance" group mentoring that includes a violence prevention curriculum and parent
      sessions. Immediately post-intervention and again at six-month follow up, youth
      violence-related, mental health and educational outcomes using validated measures will be
      assessed.
    

Intervention name(s): Group Mentoring/Intervention
Intervention type(s): Behavioral
Intervention description(s): Study participants randomized to intervention will be enrolled in a Y in Central Maryland group mentoring program that meets weekly over a three month period. Parents will participate in three parenting sessions.
Other intervention name(s): A Fighting Chance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern.
      Sleeve dilatation and loss of food restriction is considered the main mechanism. The
      placement of a silicon ring around the gastric tube seems to give benefits in the short-term.

      The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard
      sleeve in the mid-term.

      Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG),
      and they underwent a mean follow-up of 4 years.

      Patients' management was exactly the same, apart from the band placement. After surgery
      differences in weight loss, operative time, complication rate and mortality were analyzed.
    


Intervention name(s): sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Comparison of banded and not-banded sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleeve gastrectomy; banded sleeve; obesity surgery
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG®
      Rapimelt (zolmitriptan) in healthy male volunteers.
    


Intervention name(s): Rapimelt; [11C]AZ10419369
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.; solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt
Other intervention name(s): ZOMIG®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Migraine; ZOMIG® Rapimelt
A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of food on the bioavailability (how much
      medication is in your blood) of mebendazole from a single 500 mg oral dose of a
      fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
    

Detailed description: 
      This is an open-label (the participant and the study physician know what the participant is
      getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover
      (method used to switch participants from one treatment arm to another in a clinical study)
      study in approximately 16 healthy adult participants. Participants will receive study
      medication under fed state first and later under fasted state or vice versa. The study
      consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase
      consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day
      washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to
      10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study
      physician will check participant's general health during the study. Total duration of study
      for each participant will be approximately 48 days.
    

Intervention name(s): Mebendazole - fasted state (Treatment A); Mebendazole - fed state (Treatment B)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.; Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
Other intervention name(s): VERMOX; VERMOX
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Mebendazole; Fast-Disintegrating Chewable Formulation; Bioavailability
"The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"
Condition: Healthy
Study type: Interventional

Summary: 
      The study is to see if watching humor and laughing can affect CRP levels in healthy
      individuals. This is a randomized controlled trial.
    

Detailed description: 
      Subjects will be…males and females: students, employees, and members of the community.

      5. "Subjects will be between ___18_ and ___99_ years of age."

      6. "In total, subject participation will last approximately ___1 day for 90 minutes_

      7. "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and
      surrounding communities___."

      8. "Consent will take place _by investigators in Nichol Hall Room A620/A640___."

      9. If Multi-center:

      10. If Single center or investigator-initiated:

      "_60__ subjects will participate in the study."
    

Intervention name(s): humor
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: humor laughter C reactive protein