bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Platelet-Rich Fibrin in Patients With Anterior Cruciate Ligament Reconstruction
Condition: Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was conducted to investigate the effects of platelet-rich fibrin on knee stability,
      knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients
      with ACL reconstruction were included to the study and randomly divided into two groups.
      Patients were assessed preoperative and at the postoperative 1-year.
    

Detailed description: 
      The study was conducted yo investigate the effects of platelet-rich fibrin (PRF) on the knee
      stability and function in patients with anterior cruciate ligament (ACL) reconstruction.
      Thirty patients with ACL reconstruction were included to the study and randomly divided into
      two groups (PRF group and control group). Hamstring tendon autograft was used in all patients
      for the reconstruction of the teared ACL. A standardized postoperative rehabilitation program
      was applied to all patients. Patients' knee stability, knee muscle strength and knee function
      were assessed preoperatively and one-year postoperatively. Knee stability was assessed using
      KT-2000 Knee Arthrometer. Quadriceps femoris and hamstring muscle strength measurements were
      conducted with an isokinetic dynamometer at 60˚/sec and 180˚/sec angular velocities. One Leg
      Hop (OLH) and Y-Balance tests, and International Knee Documentation Committee (IKDC) were
      used to evaluate the knee function.
    

Intervention name(s): Platelet-Rich Fibrin during Standard ACL reconstruction surgery; Standard ACL reconstruction surgery
Intervention type(s): Biological; Other
Intervention description(s): Plateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft; This was a control group where patients received Standard ACL reconstruction surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anterior cruciate ligament; platelet-rich fibrin; return to play
A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin
      triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis
      C genotype 1 patients.
    

Detailed description: 
      This is an international, multicentre, randomised, double-blind, placebo-controlled, 4-arm,
      parallel-group, multiple dose phase II study comparing 3 Debio 025
      (alisporivir)/peg-IFNα2a/ribavirin regimens to SOC treatment in treatment naïve chronic HCV
      genotype 1 patients.

      Patients are randomised into 1 of 4 arms receiving either Debio 025/peg-IFNα2a/ribavirin
      triple therapy for a fixed treatment duration of 48 weeks (Treatment A) or 24 weeks
      (Treatment B), Debio 025/peg-IFNα2a/ribavirin triple therapy for a response-based treatment
      duration of 24 or 48 weeks (Treatment C), or blinded SOC treatment for 48 weeks (Treatment
      D). Follow-up is 24 weeks in all treatment arms.
    

Intervention name(s): Debio 025; Peg-IFNα2a; Ribavirin; Debio 025 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Debio 025 supplied in soft gel capsules; Peg-IFNα2a supplied in pre-filled syringes; Ribavirin supplied in tablets; Debio 025 placebo supplied in soft gel capsules
Other intervention name(s): Alisporivir; Pegasys; Copegus; Rebetol; Ribasphere; Vilona; Virazole
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Cyclosporine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis; Hepatitis C
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
Condition: Shoulder Pain; Spinal Cord Injury
MeSH terms: Shoulder Pain; Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study will compare two exercise programs in an interventional study for manual
      wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord
      injury will also be enrolled to compare exercise approaches.
    

Detailed description: 
      The investigators hypothesis is that the biomechanically based exercise program will
      demonstrate greater muscle activation of targeted muscles, and reduced compression risk to
      the rotator cuff tendons.
    

Intervention name(s): Shoulder pain and SCI; Shoulder pain and able bodies
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Shoulder pain and SCI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Shoulder Pain; Wheelchair; Spinal Cord injury
Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Condition: Disorder of Urinary Stent; Ureteral Spasm; Ureteropelvic Junction Obstruction; Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi; Hydronephrosis; Ureteral Obstruction; Multicystic Dysplastic Kidney
Study type: Interventional

Summary: 
      This study plans to learn more about whether ibuprofen can reduce pain after removal of a
      ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral
      stent. The investigators plan to learn how often this occurs and whether it can be prevented.

      The investigators hypothesize that children who have a temporary, indwelling ureteral stent
      will experience a significantly less post-operative pain if given a non-steroidal
      anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo.
      The investigators hypothesize that the incidence of severe post-stent removal pain is similar
      to an adult population.
    


Intervention name(s): Ibuprofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal; Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ureteral stent; stent pain; ureteral spasm; NSAID; ibuprofen; placebo; ureteropelvic junction obstruction; urolithiasis
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex
      in acutely manic subjects
    


Intervention name(s): Placebo; Ziprasidone; Ziprasidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo with mood stabilizer (either lithium or divalproex); Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex); Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Other intervention name(s): Geodon, Zeldox; Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
Condition: Abortion
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under
      paracervical block.
    


Intervention name(s): 50% N2O- 50%O2 mixture; Placebo (air)
Intervention type(s): Drug; Drug
Intervention description(s): 50% N2O- 50%O2 mixture administration; Placebo administration during the intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exercise in Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Background The Al-Andalus physical activity intervention study is a randomised control trial
      to investigate the effectiveness of a land- and water-based exercise intervention for
      reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness
      and pain-related measures, body composition, functional capacity, physical activity and
      sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive
      function (secondary outcomes) in women with fibromyalgia.

      Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited
      from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will
      be randomly assigned to a usual care (control) group (n=60), a water-based exercise
      intervention group (n=60) or a land-based exercise intervention group (n=60). Participants in
      the usual care group will receive general physical activity guidelines and participants
      allocated in the intervention groups will attend three non-consecutive training sessions (60
      minutes each) per week during 24 weeks. Both exercise interventions will consist of aerobic,
      muscular strength and flexibility exercises.

      Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve
      patients' health status by implementing two types of exercise interventions. Results from
      this study will help to assess the efficacy of exercise interventions for the treatment of
      fibromyalgia. If the interventions would be effective, this study will provide low-cost and
      feasible alternatives for health professionals in the management of fibromyalgia. Results
      from the Al-Andalus physical activity intervention will help to better understand the
      potential of regular physical activity for improving the well-being of women with
      fibromyalgia.
    


Intervention name(s): water-based exercise; land-based exercise intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventions will consist of aerobic, muscular strength and flexibility exercises in the water; Interventions will consist of aerobic, muscular strength and flexibility exercises in the land
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; exercise; physical activity; pain
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated
      adrenal androgens
    

Detailed description: 
      This is a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of
      tildacerfont in approximately 39 women with PCOS and elevated adrenal androgens assessed by
      elevated DHEAS levels. Subjects will be randomized 2:1 (tildacerfont:placebo) at baseline.
      The study will consist of 3 consecutive 4-week treatment periods at each dose level. Duration
      of participation is approximately 25 weeks.
    

Intervention name(s): Tildacerfont; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet formulation taken once daily.; Non-active dosage form taken once daily.
Other intervention name(s): SPR001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PCOS; Elevated Adrenal Androgen; Adrenal Disorder; Polycystic Ovary Syndrome; Womens health
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous studies have shown that TNBC is sensitive to DNA crosslinking-related
      chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective
      clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant
      chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain
      extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to
      explore a more effective and safer new adjuvant therapy for TNBC.
    

Detailed description: 
      In this study, TNBC patients were randomly divided into experimental group and control group,
      the ratio of experimental group to control group was 1:1. The experimental group received 6
      cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1,
      2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 +
      adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To
      compare the efficacy and safety of 6*TP (docetaxel + cisplatin) regimen and traditional 6*TAC
      (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
    

Intervention name(s): Docetaxel +doxorubicin+ cyclophosphamide; Docetaxel +Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.; The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
Other intervention name(s): TAC regimen group; TP regimen group
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to collect real-world safety and performance data on the MIVI
      Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and
      thrombi in the neurovascular system during acute ischemic stroke.
    

Detailed description: 
      The purpose of this study is to demonstrate the safety and performance of the MIVI
      Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft
      emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an
      observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50
      subjects at a maximum of 5 sites in Spain. Subjects data will be collected through
      hospitalization with a 3 months post-procedure study visit. This study is designed for
      observational data to be collected and reported.
    

Intervention name(s): Q Aspiration Catheter
Intervention type(s): Device
Intervention description(s): The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Population is patients diagnosed with large vessel occlusion acute ischemic stroke within 8
        hours of stroke onset treated with mechanical aspiration thrombectomy with the Q Aspiration
        Catheter as first line therapy.
      
Keywords: Mechanical thrombectomy; Acute ischemic stroke; neurovascular intervention
A Study To Evaluate PRX-00023 In Patients With Generalized Anxiety Disorder (GAD)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in
      adults with GAD.

      Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who
      fulfill the inclusion/exclusion criteria, will be enrolled in this study.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in
      adults with GAD.

      Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who
      fulfill the inclusion/exclusion criteria, will be enrolled in this study.

      This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in
      adults with GAD.

      Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who
      fulfill the inclusion/exclusion criteria, will be enrolled in this study.
    

Intervention name(s): PRX-00023
Intervention type(s): Drug
Intervention MeSH terms: Naluzotan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound
Condition: Alcoholism; Cirrhosis; Hepatitis c
MeSH terms: Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis; Alcoholism
Study type: Observational

Summary: 
      The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C
      patients with advanced fibrosis, using endoscopic ultrasound.
    

Detailed description: 
      Background: Transabdominal ultrasound cannot be used to quantitate fibrosis in patients with
      cirrhosis due to variability in the abdominal wall thickness and composition. This
      variability can be eliminated by using endoscopic ultrasound.

      Aim: To determine the amount of fibrosis in the liver of hepatitis C patients with advanced
      fibrosis, using endoscopic ultrasound.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and
        patients with hepatitis C Cirrhosis.
      
Keywords: Alcoholic cirrhosis; hepatitis c cirrhosis; cirrhosis
A Short Term Open, Randomized Cross-over Trial Exploring the Effect of Carbonic Anhydrase Inhibition by Acetazolamide on Sleep Apnea Associated Hypertension and Vascular Dysfunction
Condition: Obstructive Sleep Apnea; Sleep-Disordered Breathing; Blood Pressure; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a short term open, randomized cross over trial to explore and compare the efficacy of
      pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related
      hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ), Continuous
      Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week wash-out
      period all study participants will receive the alternative treatment regimen. The total
      length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on blood
      pressure,hemodynamics and sleep apnea will be investigated.

      Study hypothesis:

      Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce
      blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will
      induce a direct pharmacological effects on vascular stiffness as evidenced in overnight
      non-invasive assessments of vascular stiffness and that this effect will be particularly
      strong in patients also responding with a reduction of blood pressure.
    


Intervention name(s): Acetazolamide; nasal Continuous Positive Airway Pressure (nCPAP)
Intervention type(s): Drug; Device
Intervention description(s): Acetazolamide, 250mg tablets, will be administrated as multiple doses. Dosing of acetazolamide will be up-titrated during 3 days according to manufacturer instruction and titration scheme of the study. Maximum daily dosage is 750 mg (equivalent of 3 tablets/daily). Evening medication should be taken 2 hours before bedtime. The total length of Acetazolamide treatment will be 4 weeks (2x2) including 3 days of titration phase of the drug.
Other intervention name(s): Diamox®; ATC-code: S01E C01; nCPAP - Nasal Continuous Positive Airway Pressure.; ResMed - S9 AutoSet™
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acetazolamide; Zonegran; Obstructive Sleep apnea; Apnea; Respiration Disorders; Sleep Disorders; Cardiovascular; Hypertension; Carbonic Anhydrase; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors; Sulfonamides; Therapeutic Uses; Pharmacologic Actions; Vascular stifness
The Effect of Mixed Exercise and Metabolic Stress in Relationship to Age in Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in
      each burst. Stress-associated mechanisms introduced by acute illness and chronic disease
      decrease LH and Te secretion further. A major unresolved issue is whether the aging process
      heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te
      secretion. This study will assess LH and Te secretion in response to a physical stressor
      (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in
      healthy men ages 18-80 yr.
    


Intervention name(s): Hyperglycemia; Saline; Exercise; Blood Draws; Fasting procedure
Intervention type(s): Drug; Drug; Other; Procedure; Other
Intervention description(s): Hyperglycemia (rest controlled) will be induced by i.v. injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.; Saline (rest controlled) will be induced by i.v. injection of 25 mL of saline over 3 minutes with the subject supine.; Monitored exercise of 7-minute biking, 2-minute arm weights and a blood draw at the 10-minute time point will be repeated 3 times,which takes 30 minutes.
Bilateral arm curls begin at 20 pounds and decrease by 5 pounds as needed to sustain 2 minutes of exercise at a rate of 1 complete curl every 2 seconds.; Blood will be sampled every 10 min from 0700 to 1300 h. Each intervention will begin at 0800 h after 1 h of baseline sampling, and be completed by 0900 h. Intervention is followed by 4 additional h of sampling to capture recovery (total sampling 6 h). Ten-min samples are for Te, LH, ACTH, cortisol, and GH. Glucose will be checked every 30 min. At 07000 h an archival serum sample will be obtained for safety-monitoring purposes.; Beginning at 1900 h on the evening prior to each study visit, subjects will remain fasting except for water, diet soda, and other non-caloric and non-caffeinated fluids, until 1300 h the next day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy; Male