bioihbjkbjnl/mcl2 huggingface dataset:
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Condition: Breast Feeding; Constipation; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the amount of linaclotide and its active metabolite
      (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg,
      145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
    


Intervention name(s): linaclotide
Intervention type(s): Drug
Other intervention name(s): Linzess
Intervention MeSH terms: Linaclotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Linzess
A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen
Condition: Virus Diseases; HIV
MeSH terms: Virus Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI
      regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.
    


Intervention name(s): Switch NRTIs as a Backbone to Raltegravir
Intervention type(s): Drug
Intervention description(s): This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA <75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety
Lymphedema Study for Arm or Leg Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the effectiveness of a study drug versus placebo in the treatment of
      lymphedema.
    

Detailed description: 
      Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects.

      Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is
      double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and
      efficacy.

      We will try to determine how the study drug affects the body tissue by obtaining tissue
      biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.
    

Intervention name(s): Ketoprofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to match ketoprofen.
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lymphedema; edema; swelling
Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Condition: Sexually Transmitted Infections
MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The primary goal of this project is to improve the process for contacting patients that test
      positive for a sexually transmitted infection (STI) in the emergency department by using text
      messaging. We believe patients that are contacted by both a phone call and a text message
      will be reached more often and they will be reached sooner than those that only receive a
      phone call or only a text message. In addition, patients will be given reminder cards at the
      time of testing to remind them that they will be contacted within 7 days if they test
      positive. Half of the reminder cards will have a number to call for test results. We believe
      patients that receive a card with a number are more likely to be contacted within 7 days.
    

Detailed description: 
      Aim 1: To improve the results notification system among all female adolescents who test
      positive for STIs in the ED using mobile phone texting technology.

      Hypothesis 1: We will increase our contact rate for STI positive adolescents in the ED from
      65-82%.

      Hypothesis 2: We will decrease the time interval between testing and appropriate STI
      treatment by the ED.

      Hypothesis 3: We will decrease the recidivism rates for STI positive patients diagnosed in
      the ED.

      Aim 2: To explore qualitatively the barriers to and preferences for partner notification and
      treatment among 14-21 year-old females and males being tested for STIs in the ED.

      Aim 3: To determine baseline rates of partner notification and preferences around partner
      notification among STI-positive females in the ED, and to explore the feasibility of ED
      personnel notifying their sexual partners.
    

Intervention name(s): Call when test results are ready; Text message when test results are ready; Call and text message when test results are ready
Intervention type(s): Other; Other; Other
Intervention description(s): Patients are called when the test results are ready; Patients receive a text message when results are ready; Patients receive both a call and a text message when test results are resay
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: STI, STD
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
Condition: Hematologic Neoplasms; Multiple Myeloma; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Myelofibrosis
MeSH terms: Multiple Myeloma; Neoplasms; Hematologic Neoplasms; Hemoglobinuria; Primary Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at whether the combination of lower-dose chemotherapy
      with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody
      medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so
      that those cells take hold and build a healthy new blood cell factory after transplant. The
      study will also look at the safety of the combination of drugs and of the transplant of
      peripheral blood stem cells from a healthy relative or an unrelated donor.
    

Detailed description: 
      Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after
      administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be
      associated with satisfactory engraftment and acceptable post-transplant non-relapse
      mortality.
    

Intervention name(s): busulfan, and melphalan, and alemtuzumab
Intervention type(s): Drug
Intervention description(s): intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).
intravenous melphalan 100 mg/m2 on day -3.
intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.
Other intervention name(s): Busulfan (Busulfex®),; Melphalan (Alkeran®); Alemtuzumab (Campath®)
Intervention MeSH terms: Melphalan; Busulfan; Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematologic malignancies; lymphoma, leukemia, MDS (myelodysplastic syndrome); reduced-intensity preparative regimen; allogeneic peripheral blood stem cell transplant; myelofibrosis or other myeloproliferative syndromes
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Condition: Chronic Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of an adrenocorticoid antagonist
      (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous
      chorioretinopathy (CSC).
    

Detailed description: 
      A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography,
      Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if
      applicable will be done on the screening visit. If the patient is eligible, the patient will
      be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The
      patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete
      ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.

      Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.

      On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be
      done. Adverse events, and concomitant medications and treatments will be reported on all
      visits.
    

Intervention name(s): ketoconazole
Intervention type(s): Drug
Intervention description(s): 600mg. /day for 6 weeks
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Rotation With a Multifocal Toric Contact Lens
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study to
      confirm a finalized design of a prototype contact lens. There will be eight study lens types,
      however, each subject will only be randomized to receive two study lens types.
    


Intervention name(s): Test Lens
Intervention type(s): Device
Intervention description(s): Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of an internet based diet plus a regular
      dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group)
      on weight loss in obese and overweight female adults.
    


Intervention name(s): Internet Diet; Clinic Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ID group have online dietary coach every 2 weeks; CD group have every 2 weeks visit at clinic
Other intervention name(s): ID; CD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: weight loss; internet-based diet; online dietary coach; clinic visit approach; Diet
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
Condition: Twin Pregnancy With Antenatal Problem
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study aims to determine whether the Arabin cervical pessary prevents preterm birth in
      women with a twin pregnancy and a short cervix.
    

Detailed description: 
      STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE
      marked Device) versus Standard treatment in women with twin pregnancy. The study is in two
      phases - a SCREENING phase, in which women with a short cervix (cervical length of ( less or
      equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix
      will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen
      in the antenatal clinic setting.

      An internal pilot phase will take place, with ten interviews being conducted with pregnant
      women to explore the acceptability of proposed methods of recruitment, their information
      requirements, their views of the consent and randomisation processes, and the delivery of the
      intervention, including the screening component. The interviews will also explore their
      understanding and expectations of trial participation. The findings of this pilot phase will
      feed into the next phase of the trial and support the design of the interview guides for the
      main nested qualitative study.

      This pilot phase is separate from the main study. Later on we will ask both women and
      healthcare professionals about their experiences of the study, via questionnaires and
      face-to-face interviews.
    

Intervention name(s): Arabin Cervical Pessary
Intervention type(s): Device
Intervention description(s): The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Twin Pregnancy; Prevention of Preterm birth; Short Cervix; Arabin cervical pessary
How do You Take Your Coffee Before Anesthesia
Condition: Anesthesia; Aspiration; Fasting
Study type: Interventional

Summary: 
      Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty
      and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2
      hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or
      tea without milk or sugar, and juices without pulp. Many Americans prefer to take their
      coffee with half and half or coffee creamer rather than black. This study will determine
      whether the addition of a small amount of cream to coffee makes any difference to the volume
      in the stomach after 2 hours.

      This study will use healthy volunteers as study participants. Each participant will
      participate in the study 3 times with at least 2 days in between. We will use a bedside
      ultrasound machine to measure their stomach content volume at baseline and then they will
      consume one of 3 different prepare drinks - black coffee, coffee with half and half, or
      coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and
      measure stomach content volume and compare it to the first measurement. The participants will
      repeat this two more times on different days so that they would have had a chance to consume
      all three prepared coffee drinks in a random order.
    


Intervention name(s): Addition of half and half to coffee; Addition of non-dairy creamer to coffee; Black
Intervention type(s): Other; Other; Other
Intervention description(s): 1 oz of half and half is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound; 1 oz of non-dairy creamer is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound; No Creamer
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Controlled Crossover
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Condition: Shoulder and Upper Arm Injury
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      There are different techniques of interscalene brachial plexus block, we aimed to evaluate
      the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general
      anesthesia.
    

Detailed description: 
      Prospective randomized controlled study

      There were 4 groups included in our study:

      Group N: nerve stimulator guided interscalene brachial plexus block was done Group U:
      ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using
      both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart
      rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power
      loss and their offset, and finally patient satisfaction.
    

Intervention name(s): ultrasound and nerve stimulator
Intervention type(s): Device
Intervention description(s): nerve stimulator and ultrasound guided interscalene brachial plexus block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: shoulder arthroscopy
Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a study to better understand how a yoga intervention helps improve symptoms in people
      with chronic low back pain. This study will be a 12-week intervention of about 24
      participants with chronic low back pain where all individuals will receive weekly yoga
      classes and instructions for home practice. The purpose of this study is to collect
      feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH
      study.
    


Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Gain in Surgically Treated Adult-onset Craniopharyngioma
Condition: Adult-onset Craniopharyngioma; Postoperative Weight Gain
MeSH terms: Craniopharyngioma; Adamantinoma; Body Weight; Weight Gain
Study type: Observational

Summary: 
      The aim of the study was to describe postoperative weight change in adults undergoing surgery
      for craniopharyngioma and identify preoperative factors associated with it.
    

Detailed description: 
      Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling
      complication in patients undergoing surgery for craniopharyngioma combined or not with
      radiotherapy, with an incidence of 23~62% in pediatric patients. It has a major negative
      impact on metabolic and cardiovascular health and quality of life in long-term survivors.
      Identifying patients at higher risks for developing postoperative weight gain is of great
      importance in preventing obesity and taking early actions in this population. Though a lot of
      previous studies have been made in pediatric patients and several factors, such as
      hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at
      diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk
      factors for postoperative weight gain, data on this important morbidity in adult-onset
      patients are sparse, especially in Chinese population. Therefore, the investigators are going
      to undertake a retrospective evaluation of postoperative weight change in adult-onset
      patients undergoing surgery for craniopharyngioma and identify preoperative factors
      associated with it.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adult-onset patients with craniopharyngioma undertaking primary surgery in the
        investigators' institution
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children
Condition: Wrist Fractures; Forearm Fractures; Elbow Fractures; Ankle Fractures; Foot Fractures; Wounds and Injuries
MeSH terms: Fractures, Bone; Ankle Fractures; Wounds and Injuries; Wrist Fractures; Elbow Fractures
Study type: Interventional

Summary: 
      This is an evaluation of the functionality and added value of cork splint materials instead
      of a plaster splint for children (3-11 years old).
    


Intervention name(s): Cork splint materials (instead of plaster splint)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fractures of the wrist, forearm, elbow, ankle, foot; Distortions of the wrist, elbow, ankle; Wounds without tendon injuries
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
Condition: HCV Coinfection
MeSH terms: Coinfection
Study type: Interventional

Summary: 
      Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those
      patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir
      /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/
      paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to
      prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.
    

Detailed description: 
      HCV management with new DAAs is now promising. However, many cases reporting treatment
      failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir.
      retreat those patients is challenging. So, we aimed to Study the efficacy and safety of
      Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/
      paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to
      prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.
    

Intervention name(s): Sofosbuvir; Simeprevir; Daclatasvir; Ribavirin; Ombitasvir/paritaprevir/ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sofosbuvir 400 mg oral pills; Simeprevir 150 mg oral pills; Daclatasvir 60 mg oral pills; Ribavirin 200 mg oral pills; Ombitasvir/paritaprevir/ritonavir oral pills
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; DAAs; Non-responder
Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and
      norepinephrine adjusted according to body weight on fetal acid-base balance and maternal
      hemodynamics.
    

Detailed description: 
      At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of
      cesarean section hypotension has been explored. We compare the effects of three drugs on the
      fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive
      drugs for obstetrics anesthesia .
    

Intervention name(s): metaraminol; Phenylephrine; Norepinephrine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.; Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.; Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
Other intervention name(s): M group; P group; N group
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Metaraminol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention