bioihbjkbjnl/mcl2 huggingface dataset:
Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      With this study two different therapeutic exercise regimens will be compared in patients with
      anterior knee pain (patellofemoral pain syndrome, PFPS).
    

Detailed description: 
      Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome
      (PFPS), but there is still no consensus on recommending any specific rehabilitation program.

      This study evaluates two different therapeutic exercise regimens in patients with PFPS and
      their effect on pain at rest and function.

      Supervised exercise therapy will be applied in both groups three times a week over a 3-month
      period with individually tailored and graded exercise programs, differing between groups in
      terms of number of exercises, number of repetitions and sets, and time spent on performing
      aerobic exercises.
    

Intervention name(s): High exercise therapy; Low exercise therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee; Anterior Cruciate Ligament; Pain; Patella; Exercise Therapy
Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
Condition: Arteriovenous Fistula
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      This research was conducted as a randomized controlled experimental study aiming to determine
      the impact of virtual reality glasses used in the AVF process on the pain felt by patients
      and patient satisfaction.
    

Detailed description: 
      Chronic kidney disease (CKD) is a progressive, irreversible renal disease in which the
      ability of the body to maintain the balance of metabolism, fluid and electrolytes fails.
      Chronic kidney disease (CKD) is one of the major health problems with an increasing
      prevalence in the World. Hemodialysis as one of the most common methods of renal replacement
      therapy is a stressful procedure despite to maintain the survival of patients with chronic
      kidney disease that permanent and safe vascular access is one of the requirements of a
      successful hemodialysis. The pain of AVF puncture is common among the patients undergoing HD
      as acute and chronic pain which reported in more than 82% and 92% of them, respectively.
      Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on
      the patients, it causes that hemodialysis patients experience more disability, depression,
      irritability, and insomnia than other patients in adapting to stress. Experiencing continued
      pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease
      quality of life. Therefore, pain control is an important priority in these patients.
    

Intervention name(s): Study Group
Intervention type(s): Other
Intervention description(s): The patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Virtual Reality Glasses; Nursing; Pain; Patient Satisfaction
Irrigation and Suction Trial to Prevent SSI
Condition: Surgical Site Infection; Diabete Mellitus; Abdominal Hysterectomy
MeSH terms: Infections; Surgical Wound Infection; Diabetes Mellitus
Study type: Interventional

Summary: 
      The study will be conducted on women with risk factors for SSI assigned to gynecological
      surgery with an open abdominal approach. The participants will be designated to either
      Irrigation and suction arm by bilateral drain insertion or the control arm by randomization
      through the parallel assignment. The participants will be followed for the outcome for four
      days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary
      outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative
      pain, other complications and patient satisfaction.
    

Detailed description: 
      This study will be carried out in Lady willingdon Hospital, Lahore. In this study, we will
      recruit middle-aged and elderly diabetic women who have been assigned to open abdominal
      hysterectomy due to different gynaecological reasons. This cohort is at great risk of
      surgical site infection and other risk factors of SSI like hypertension, hepatitis and
      malignancy may coexist in these women. The study period will span to include three hundred
      participants as calculated according to sample size. The women will be divided into either an
      I&S group or a control group by a simple random number container method. The women in the I&S
      group will be inserted with bilateral drains during surgery in subcutaneous tissue after the
      closure of the rectus sheath and irrigated with saline followed by suction through syringe
      suction attached to the wound for rest of the day. The procedure will continue for three
      days. On the fourth day, drains are removed and stitches are removed on the fourth
      postoperative day. In the control group, the wound will be closed by interrupted stitches
      without the insertion of subcutaneous drains. The dressing will be done daily for seven days.
      patients with no symptoms and signs of SS will be sent home on the eighth postoperative day.
      The patients will be followed for symptoms of SSI, pain, readmission rate, and other
      complications at 4,8 and 12 weeks.
    

Intervention name(s): Irrigation and suction through subcutaneus drains
Intervention type(s): Device
Intervention description(s): Irrigation of wound will done by attaching 500cc saline to the drain on one side and let it flow freely from the other drain followed by suction of wound by attaching 60cc suction syringes on both sides creating suction pressure for 100 cc fluid.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomized by the random number container method into an equal number of I&S groups and control groups through the parallel assignment.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: suction,; Wound healing; pain; Hysterectomy
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from
      the body.
    


Intervention name(s): ALS-008176; ALS-008112
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Condition: Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
      Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
      alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being
      replaced by scar tissue).
    


Intervention name(s): BMS-986036; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days.; Specified dose on specified days.
Other intervention name(s): Pegbelfermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION
Condition: Surgical Site Infection; Gynecologic Cancer; Wound Drain
MeSH terms: Infections; Surgical Wound Infection; Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of the present randomized trial is to assess the efficacy of wound drains in terms of
      reducing the rates of surgical site infection in obese patients with gynecological cancer.
    

Detailed description: 
      Many prophylactic methods have been suggested for the treatment of surgical wound infections,
      including the prolonged administration of antibiotics as well as the use of subcutaneous
      tissue drainage, the use of which has been shown to be particularly effective in overweight
      patients. While its importance seems to be moderate in obese patients as well as those that
      suffer from malignant disease, to date, it remains unknown if wound drains may help reduce
      the rates of surgical site infection in obese patients that suffer from cancer. In the field
      of gynecological oncology data are limited to anachronistic studies whose methodological
      value is limited; hence, guidelines are primarily based in data of high risk of bias as to
      date, the value of subcutaneous tissue drainage in obese women undergoing surgery for
      gynecological cancer has not been documented in a large randomized study.

      Considering the significant impact of surgical site infection on the interval to adjuvant
      therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy),
      it becomes evident that every effort has to be made in order to help reduce the rates of SSI
      to help maintain acceptable intervals that will ensure appropriate care of patients.
    

Intervention name(s): Surgical drain
Intervention type(s): Procedure
Intervention description(s): In this arm a surgical drain will be inserted prior to surgical wound closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The objective of this trial is to compare the efficacy of electroacupuncture versus
      transcutaneous electric nerve stimulation for functional constipation
    

Detailed description: 
      Both electroacupuncture(EA) therapy and transcutaneous electric nerve stimulation(TENS) are
      safe and effective for functional constipation, but no head to head comparing trial was
      conducted.

      Methods：102 participants with functional constipation will be recruited and randomly
      allocated into the EA group and the TENS group.Participants in both groups will receive EA or
      TENS treatment at Tianshu(ST 25), Fujie(SP 14) and Shangju xu(ST 37) 3 times a week for 8
      weeks.
    

Intervention name(s): Electroacupuncture; TranscutaneousElectricNerveStimulation
Intervention type(s): Device; Device
Intervention description(s): Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.; Participants will receive transcutaneous electric nerve stimulation at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
Other intervention name(s): EA; TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; functional constipation; transcutaneous electric nerve stimulation; randomized controlled trial
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple
      Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with
      Alzheimer's Disease Type Dementia.
    


Intervention name(s): CPC-201
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of
      tipranavir/r on BILR 355 BS pharmacokinetics
    


Intervention name(s): BILR 355 BS; Tipranavir; Low dose of ritonavir; High dose of ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA
      Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.
    

Detailed description: 
      A pivotal, single-dose, randomized, open-label, partial replicate, three-period,
      three-sequence, two-treatment, three-way crossover, comparative bioavailability study.

      Ninety-nine, male and female volunteers, 20-45 years of age, with a body mass index (BMI)
      within 18.5-30.0 kg/m2, inclusive, will be enrolled. (The body weight should be over 50 kg,
      inclusive, respectively)

      A single dose of 8 puffs (equivalent to budesonide 1280 μg/formoterol fumarate dihydrate 36
      μg) in each study period.
    

Intervention name(s): Budesonide; Formoterol
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled corticosteroid; Long Acting Beta Agonist (LABA)
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Condition: Bile Acid Malabsorption; Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Malabsorption Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral
      stimulation with chenodeoxycholic acid in the same subjects before and after elective
      cholecystectomy
    

Detailed description: 
      Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid
      diarrhoea (BAD), a disease with increasing estimated of prevalence.

      BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by
      cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be
      developed to a universal test for BAD, and need to know how the proposed test is affected by
      cholecystectomy.
    

Intervention name(s): chenodeoxycholic acid
Intervention type(s): Drug
Intervention description(s): 1250 mg CDCA is given with a study meal
Other intervention name(s): CDCA; chenodeoxycholate
Intervention MeSH terms: Chenodeoxycholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide
      administered once daily for 24 weeks, compared to placebo, in patients with multiple
      sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].

      The secondary objectives were:

        -  to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in
           combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,
           relapse rate and patient-reported fatigue;

        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
           a stable dose of GA.
    

Detailed description: 
      The duration of the study period for a participant was approximatively 44 weeks broken down
      as follows:

        -  Screening period up to 4 weeks,

        -  24-week double-blind treatment period*,

        -  16-week post-treatment elimination follow-up period.

      '*' Participants successfully completing the week 24 visit were offered the opportunity to
      enter the optional long-term extension study LTS6047 - NCT00811395.
    

Intervention name(s): Teriflunomide; Placebo (for teriflunomide); Glatiramer Acetate (GA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet
Oral administration; Film-coated tablet
Oral administration; Solution in prefilled syringe for subcutaneous injection
Other intervention name(s): HMR1726; Copaxone®
Intervention MeSH terms: Teriflunomide; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; glatiramer acetate; adjunctive therapy; relapses
Neuroscience-Informed Treatment Development for Adolescent Alcohol Use
Condition: Alcohol Drinking; Control
MeSH terms: Alcohol Drinking; Underage Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant
      supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI).
    

Detailed description: 
      55 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice
      daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days.
      Urine and blood samples will be collected at baseline and urine samples again before and
      after each course of medication treatment. Participants will receive a 1- hour MRI scan at
      baseline and after each treatment trial.
    

Intervention name(s): N-Acetylcysteine; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): N-Acetylcysteine; 600mg capsules by mouth, two pills twice daily (total 2400 mg/day). Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.; N-acetylcysteine-matched placebo tablet two pills twice daily. Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: adolescent
Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, single -center study in 2 parts. The study designs for each part are well
      established for first-in-human studies and are appropriate to assess safety, tolerability and
      preliminary pharmacokinetics& pharmacodynamics.
    

Detailed description: 
      This is a randomised, single-blinded, placebo-controlled, single centre, phase 1 trial.

      Eight healthy males or females, aged between 18-55 years old, who meet all of the inclusion
      criteria and none of the exclusion criteria, will be enrolled.

      The study will be composed of 2 groups to be enrolled sequentially.

      • Group 1a (sentinel group): two participants will be randomised single-blinded such that one
      participant will receive AL+Rux and the other participant will receive AL+placebo.

      After review of the safety and tolerability data up to and including Day 8 from Group 1a by
      the Safety Review Committee (SRC), a decision to proceed with Group 1b will be made.

      • Group 1b will be composed of 6 participants, to be randomised single-blinded such that five
      participants will receive AL+Rux, and one participant will receive AL+placebo.
    

Intervention name(s): 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux); 20 mg/120 mg artemether-lumefantrine (AL) + Placebo
Intervention type(s): Drug; Other
Intervention description(s): Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).; Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
Other intervention name(s): Sentinel Group 1 a and 1 b; Sentinel Group 1 a and 1 b
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 2 groups each to be enrolled sequentially. Group 1a will be a sentinel group of 2 participants, and Group 1b will be composed of 6 participants; to be administered either AL + Ruxolitinib or AL + placebo.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Saftey; Tolerability
Inulin and Acetate Production and Human Substrate Metabolism
Condition: Obesity; Pre Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will
      be fermented into a SCFA pattern high in acetate and that this will lead to beneficial
      effects on human substrate and energy metabolism, we aim to address the following primary
      objective:

      To investigate the effects of an acute administration of inulin/beta glucan in combination
      with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial
      substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
    


Intervention name(s): Inulin and Resistant Starch; Inulin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g; 12g per inulin in combination with maltodextrin per day the day before the CID; isocaloric maltodextrin before test day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science