bioihbjkbjnl/mcl2 huggingface dataset:
Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Condition: Endometriosis Ovary
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Endometriosis is a disease characterized by the presence of endometrial tissue outside the
      uterus cavity, causing important chronic pain and sterility in those patients suffering from
      it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis,
      which can coexist in the same patient, exist: deep infiltrating endometriosis (implants
      infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA).
      OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured
      during resection. Consequently, ovarian reserve decreases, worsening the reproductive
      prognosis of patients affected. The main objective of the present study is to compare laser
      versus conventional OMA excision according to ovarian reserve in a pairwise-data study.
    


Intervention name(s): CO2 (carbon dioxide) laser vaporisation; Stripping technique
Intervention type(s): Procedure; Procedure
Intervention description(s): CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma; Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of
      the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI)
      Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in
      the superficial femoral and/or popliteal arteries.

      Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
    

Detailed description: 
      Cohort 1:

      The purpose of this single arm study is to continue to assess safety and performance of the
      Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial
      femoral (SFA) and/or popliteal arteries.

      Cohort 2:

      A second cohort is being added to evaluate this patient population for treatment of in-stent
      restenotic lesions.

      Cohort 1:

      Prospective, multi-center, single-arm study.

      Cohort 2:

      Prospective, multi-center, single-arm study compared to a historical control.

      Cohort 1:

      Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months, 36
      months, 48 months, and 60 months following the study procedure.

      Cohort 2:

      Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months and 36
      months following the study procedure.
    

Intervention name(s): Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
Intervention type(s): Device
Intervention description(s): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Other intervention name(s): CVI Paclitaxel-Coated PTA Balloon Catheter
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With ASD
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      It was proposed that in order to teach these children to use a Voice Output Communication Aid
      (VOCA), it should be introduced through a play-based situation using parents as the primary
      interventionist.
    

Detailed description: 
      The research will test the effectiveness of using the communication board to improve the
      frequency of communication and social engagement for these children, and the level or
      sophistication of that engagement. The study will test the effectiveness of using the
      communication board in a variety of settings and a variety of practitioners. The study will
      have sites in and near Jonesboro, Arkansas.
    

Intervention name(s): communication training
Intervention type(s): Behavioral
Intervention description(s): Participants were instructed in the use of a voices output communication aid.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism spectrum Disorders; Voice Output Communication
Sustained Natural Apophysial Glides (SNAGs) Technique in Non-Specific Neck Pain Patients
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Mechanical neck pain is defined for the absence of cervical spinal pathologies.With the SNAGs
      mobile mobilization method, it reveals effective results in cases of limitation and pain in
      the cervical joints.Although there are studies with the Mulligan concept in the literature,
      studies examining the effects of the SNAGs technique on non-specific neck pain are limited.

      The aim of this study is to investigate the effectiveness of the Mulligan Concept SNAGs
      mobilization method applied in addition to the conventional physiotherapy program in
      individuals with nonspecific neck pain.
    

Detailed description: 
      This study was conducted to investigate the effectiveness of Mulligan concept cervical
      sustained natural apophysial glides (SNAGs) mobilization method in addition to the
      conventional treatment program in patients with nonspecific neck pain. The study included 40
      patients (18-50 years of age) with non-specific neck pain, radicular compression and loss of
      strength for at least 3 months, diagnosed by a specialist physician; patients with central
      nervous system disease, distal-peripheral nerve injuries Patients with inflammatory joint
      disease, cervical spine fracture or surgery, patients with upper extremity surgery, cervical
      spine tumor and infection, cervical spine congenital anomaly and diabetes were not included
      in the study. 15 sessions were applied for 3 weeks, 5 days a week for 10 weeks, 10 minutes
      ultrasound, 20 minutes transcutaneous electrical nerve stimulation (TENS) and hotpack
      application and Mulligan mobilization in addition to physiotherapy programs. The patient was
      rested for 5 seconds between sets. The physiotherapy program was applied to the control group
      and the application session was completed. Normal range of motion exercises were performed in
      both groups and given as home exercise.
    

Intervention name(s): application of SNAGs technique
Intervention type(s): Other
Intervention description(s): in experiment group, the SNAGs technique was applied to 16 participants in addition to conventional therapy.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: manual therapy; neck pain; SNAGs; sleep quality; quality of life
Effects of Neuromuscular Electrostimulation on Scapular Stability
Condition: Adult Female Handball Player
Study type: Interventional

Summary: 
      Injuries and shoulder pain are common problems in handball, more often among female athletes.
      The impact on performance and participation shows the need to work on the risk factors to
      minimize the damage. It has been found an association between scapular dysfunction and pain
      in the shoulder. Currently there are many exercise programs, but few with electrotherapy
      implemented. The aim of the study is to assess the effect of a therapeutic physical exercise
      program for scapulo-humeral stabilitation with and without electrotherapy on scapular
      stability, glenohumeral internal rotation and external rotation strength.
    


Intervention name(s): Therapeutic physical exercise program for scapulo-humeral stabilitation; Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation
Intervention type(s): Other; Other
Intervention description(s): This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation during a month; This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation added electrostimulation during a month
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: "Electric Stimulation Therapy"; "Resistance training"; "Overhead sports"; "Risk factors"; "Scapular anomalies"
Genetic Variants and Iron Absorption
Condition: Iron Absorption
Study type: Observational

Summary: 
      The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron
      status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian
      women. The investigators hypothesize that the genetic variant could enhance iron status and
      iron absorption in Asian women.
    

Detailed description: 
      To determine the HFE genotype of female Asian study volunteers, we collected venous blood
      samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT,
      and TT and used to assess possible differences in iron status as a function of genotype. To
      measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC
      (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each
      volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a
      blood sample was collected from each woman and the amount of non-heme (57Fe) iron
      incorporated into red blood cells was measured with magnetic sector thermal ionization mass
      spectrometry. Possible associations between iron status and iron absorption as a function of
      genotypes were explored. Data from this study will provide information that aims to improve
      human health by better understanding the iron requirements of individuals with different
      genetic background.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women were eligible for the study if they met the following criteria: 1) non-pregnant and
        between the ages of 18~35 y; 2) of East Asian descent with both maternal and paternal
        grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand,
        Malaysia and Singapore; 3) not taking any vitamin or mineral supplements for at least 1
        month before the study and during the 2-week study interval; 4) no pre-existing medical
        problems including malabsorption, blood disorders, ulcers, joint diseases or asthma that
        might impact inflammation or Fe status; 5) not taking any prescribed medications known to
        affect iron homeostasis.
      
Biospecimen description: 
      Two 10 mL blood samples and one 3 mL blood sample were collected.
    
Keywords: Non-heme iron absorption; HFE
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used
      medication in patients with type 2 diabetes
    


Intervention name(s): sitagliptin phosphate (+) metformin hydrochloride; Comparator: pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period; pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
Other intervention name(s): Janumet; pioglitazone
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody for Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors
      (mainly gastric cancer, esophageal cancer).

      To investigate the preliminary relationship between the expression of the ligand of PD-1
      (PD-L1) and efficacy.
    

Detailed description: 
      Dose escalation study: Primary purpose: To investigate the safety and tolerability of GLS-010
      in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). Secondary
      purpose: 1. To characterize the pharmacokinetics(PK) profile of GLS-010; 2. To determine
      dose-limiting toxicity(DLT), maximum tolerated dose (MTD) and recommended Phase II dose
      (RP2D) for GLS-010; 3. To assess the preliminary anti tumor activity of GLS-010; 4. To assess
      programmed cell death-1 (PD-1) receptor occupancy. Exploratory purpose: 1. To investigate the
      preliminary relationship between the expression of the ligand of PD-1 (PD-L1) /PD-L2 and
      efficacy; 2. To characterize immunogenicity of GLS-010. Expansion study: Primary purpose: To
      assess the preliminary anti-tumor activity of GLS-010 in subjects with advanced solid
      tumors(gastric cancer, esophageal cancer); Secondary purpose: 1. To further assess the safety
      and tolerability of GLS-010; 2. To further assess the safety and tolerability of GLS-010 in
      subjects with advanced tumors. Exploratory purpose: 1. To assess PD-1 receptor occupancy of
      GLS-010; 2. To assess the relationship between the expression of PD-L1/PD-L2 and efficacy; 3.
      To further assess the immunogenicity of GLS-010.
    

Intervention name(s): GLS-010
Intervention type(s): Drug
Intervention description(s): Recombinant Human Anti-PD-1 Monoclonal Antibody
Other intervention name(s): Recombinant Human Anti-PD-1 Monoclonal Antibody
Intervention model: Sequential Assignment
Intervention model description: 1 mg per kg, Q2W; 4 mg per kg, Q2W; 10 mg per kg, Q2W; 240 mg fixed dose, Q2W
Masking: None (Open Label)
Primary purpose: Treatment
Anterior Wedge in Patients With Osteoarthritis Hip
Condition: Gait, Frontal
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major
      disability and poor quality of life. Understand the musculoskeletal factores can lead to a
      better clinical management. The muscle strenghening of posterolateral complexo of hip is a
      important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior
      wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled
      clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be
      used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze
      of gait through of Myovídeo analysis software.
    


Intervention name(s): Application of the anterior wedge
Intervention type(s): Other
Intervention description(s): Application of anterior wedge in tennis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic
      (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the
      investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin
      aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin
      infusion (CSII).
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.; Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of maximal strength training (MST)
      compared to standard rehabilitation in patients operated with total knee arthroplasty.
      Previous studies report reduced physical function and muscle strength despite successful
      surgery inserting an artificial implant.

      Furthermore, great loss of muscle strength has been found in these patients in the early
      postoperative phase.

      The study is a randomized controlled trial. The investigators hypothesize that MST will
      increase muscle strength and physical function more than standard rehabilitation.
    


Intervention name(s): Maximal strength training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resistance training
Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors
Condition: Acute Lymphoblastic Leukemia, Pediatric
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      The goal of this clinical trial is to to compare the structure of the intestinal microbiome
      between children shortly after treatment for acute lymphoblastic leukemia (1-3 years after
      cancer treatment) and healthy controls. And then to provoke a positive shift of bacterial
      diversity by physical activity and probiotics in cured pediatric oncology patients with
      persistent gut microbiome disruptions.

      The main question[s] it aims to answer are:

        -  Are differences in bacterial richness between healthy controls and pediatric oncology
           patients ≥12 months after cancer treatment apparent?

        -  Has the combination of physical exercise and probiotics had a positive influence on the
           structure of the gut microbiome in childhood cancer survivors in remission? Two times
           per week of physical activity and daily dairy consumption with probiotics will be
           required of participants for eight weeks.
    


Intervention name(s): Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518; Physical exercise
Intervention type(s): Other; Other
Intervention description(s): The commercial probiotic dairy product has been provided to PALL along with physical training once a day for 8 weeks. Each serving contained 20 billion CFUs of Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 (Lactobacillus casei CNCMI-1518). Each patient's legal representative was advised to follow a normal diet when preparing and providing food for children.; The individual online (MS Teams) training program for PALL in the length of 8 weeks included 25-45 minutes of moderate-to-vigorous physical exercise, twice a week, under the supervision. The structure of the exercise program was developed to improve endurance and gradually rebuild muscular strength. The exercise program's structure was created to increase endurance and gradually rebuild muscular strength. Large muscle groups were the focus of training sessions, which also placed a strong emphasis on proper technique. A strength exercise squat was given consideration as a movement required to meet necessities. (e.g., sitting or standing). Each exercise consisted of between 10 and 15 repetitions in each series and 2 to 3 series overall.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical Exercise, Gut Microbiome, Exercise Training, Veillonella