bioihbjkbjnl/mcl2 huggingface dataset:
Human Milk Composition in Indian Mothers
Condition: Breast Feeding
Study type: Observational

Summary: 
      Nutritional profile of mother's milk is influenced by various factors including
      environmental, dietary and nutritional status of the mother. Given the huge diversity noted
      in nutritional status and ethnic dietary patterns in Indian population, including pregnant
      and lactating mothers, it can be conceivably predicted to have an influence on milk
      composition. With the lack of recent literature addressing these, it is vital to understand
      and update the influence if any, of nutritional status and dietary patterns on nutritional
      quality of human milk. The proposed Human milk analysis clinical study in Indian mothers is
      aimed to achieve a more recent and updated database of nutritional profile of Indian mother's
      milk considering the dietary and regional influences and demographic differences which can
      play a key role in levels of nutrients in mother's milk. In order to incorporate the varied
      dietary patterns, milk samples will be collected from mothers recruited from 8 sites across
      the country and analysed for important nutrient levels.
    

Detailed description: 
      The study is a 5-month prospective observational cohort study. Approximately 258
      mother-infant pairs in 33-42 weeks of pregnancy will be recruited. Eligibility assessment
      will be done for the mother at enrolment and for the mother-infant pair at delivery. Based on
      the recorded anthropometric data and BMI (kg/m2) calculated based on the self-reported
      pre-pregnancy weight or earliest recorded body weight from their first trimester, mothers
      consenting to the study will be categorized as either well-nourished or malnourished. All
      study centers will recruit equal number of participants in each group at their respective
      sites. As per standard of care, mothers will continue to take the prenatal supplement
      primarily consisting of folic acid, elemental iron, calcium and will be encouraged to breast
      feed their infants during prenatal visits. Breastfeeding advice normally consists of messages
      on the benefits of breastfeeding, instructions on early initiation of breastfeeding and
      proper breastfeeding techniques, and recommendation on exclusive breastfeeding for the first
      6 months. Mothers will be provided with a diary to make a note about their supplement intake
      and the frequency of breastfeeding. The entry of the details will be enquired telephonically
      (biweekly) and restated during the face follow-up sessions at study visits 3 and 4.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        258 mother-infant pair subjects (86 per group) will be enrolled. The mothers will be
        normally-nourished or undernourished or over nourished based on pre-pregnancy measured BMI
        (kg/m2).
Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
Condition: Hypermobility Syndrome Shoulder; Shoulder Pain Chronic
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility
      with one or more secondary symptomatic musculoskeletal manifestations. Current clinical
      management of this population with shoulder symptoms is a non-standardized combination of
      physiotherapy modalities including exercise prescription. There is evidence suggesting that
      progressive heavy resistance training increases muscle strength and tendon stiffness, which
      may be valuable for treatment of this population.

      The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance
      training (PHSRT) for adults with HSD and shoulder symptoms.
    

Detailed description: 
      Hypermobility Spectrum Disorders (HSD) is a recent diagnosis that covers joint hypermobility
      with one or more secondary symptomatic musculoskeletal manifestations. Current clinical
      management of this population with shoulder symptoms is a non-standardized combination of
      physiotherapy modalities including exercise prescription. There is evidence suggesting that
      progressive heavy resistance training increases muscle strength and tendon stiffness, which
      may be valuable for treatment of this population.

      The aim of this study is to evaluate the feasibility of progressive heavy shoulder resistance
      training (PHSRT) for adults with HSD and shoulder symptoms before safely performing a
      definitive RCT-study in a large cohort. The objectives are to address whether PHSRT is
      feasible regarding i) patient recruitment and retention, ii) adherence to exercise protocol
      and its progression levels, iii) completion of objective outcome measures, and iv)
      registering potential flare up in shoulder symptoms.

      Study progression criteria are based on a traffic light system of green (go), amber (amend)
      and red (stop). Results of these progression criteria will be evaluated by the investigator
      group, who will recommend amendments that need to be made before proceeding with the
      definitive RCT.
    

Intervention name(s): Progressive heavy shoulder resistance training
Intervention type(s): Other
Intervention description(s): The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.
Intervention model: Single Group Assignment
Intervention model description: Intervention group only.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Joint instability; Hypermobility; Shoulder; Strength training
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a non-randomized, open-label, parallel group, two-treatment study in healthy
      volunteers to investigate the absolute oral bioavailability of balovaptan. The study was
      conducted at 1 site in the Netherlands.
    


Intervention name(s): Oral Balovaptan; IV Balovaptan
Intervention type(s): Drug; Drug
Intervention description(s): In Period 1, balovaptan was administered as a single oral dose.
In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.; In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.
In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.
Intervention MeSH terms: Balovaptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Intra-articular (IA) Single Ascending Dose of 4P-004 in Patient With Kellgren and Lawrence Grade 2 to 4 Osteoarthritic (OA) Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to
      assess the safety and tolerability of single ascending dose of IA 4P-004 at 0.3, 1.0, 2.0 and
      3.0 mg in participants,

        -  Between 18 and 80 years of age,

        -  with target knee OA stage KL 2-4 A total of 32 participants will be enrolled in 4
           cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
    


Intervention name(s): 4P-004; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single intraarticular administration in the knee joint; single intraarticular administration in the knee joint
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OA; Knee OA; Liraglutide
Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple oral doses of
      CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This
      study will include two dose levels. For each dose level, blood samples will be collected for
      exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory
      biomarker analysis. Following multiple dose administration, pulmonary function and
      exploratory lung clearance index (LCI) measurements will be taken.
    


Intervention name(s): CTX-4430; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to patients in 2 cohorts on days 1-15.; Repeat doses of placebo will be administered orally, once-daily, to patients in 2 cohorts on days 1-15
Other intervention name(s): Mannitol
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to
      standard of care is well tolerated and superior to placebo in reducing the risk of
      cardiovascular death or heart failure events in adults with chronic heart failure with
      reduced ejection fraction (HFrEF).
    

Detailed description: 
      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): Omecamtiv Mecarbil; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omecamtiv mecarbil tablets for oral administration; Matching placebo tablets; Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.
Other intervention name(s): AMG 423
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Role of KL-6 in the Clinical Diagnosis of ILD
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among
      patients with ILD, and comparing them to the clinical diagnostic criteria and other
      respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of
      ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment
      and after treatment.
    

Detailed description: 
      As a multi-center, double-blind clinical study, the trial is divided into two parts.

      Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the
      clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among
      patients with ILD, and comparing them to the clinical diagnostic criteria and other
      respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic
      obstructive pulmonary disease and healthy control group.

      Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD
      treatment effect evaluation through the detection of serum KL-6 levels before treatment and
      30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other
      conventional therapies.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower
        Hospital and Beijing Chaoyang Hospital.
      
Biospecimen description: 
      The residual serums in the clinical laboratory.
    
Keywords: Interstitial Lung Disease; Diagnosis; Krebs Von Den Lungen-6
Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal
      injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.
    


Intervention name(s): LT-NS001; Naprosyn®
Intervention type(s): Drug; Drug
Intervention description(s): 1200 mg b.i.d. p.o. for 7.5 days; 500 mg b.i.d. p.o. for 7.5 days
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Total knee arthroplasty (TKA) is recognized as a successful procedure for treating
      osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the
      degree of knee flexion. Providing more range of motion after TKA impact on the convenience of
      daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures
      which require a lot of ground activities. Data are limited on the added benefits of
      perioperative photograph as motivation for increasing range of motion after TKA.

      Half of participants received perioperative photograph as motivation, while the other half
      did not after total knee arthroplasty.
    

Detailed description: 
      All participants received spinal anesthesia, multimodal local anesthetic infiltration and
      patient controlled analgesia (PCA) for 24 hours post surgery. The surgical techniques,
      postoperative medications and rehabilitation protocols were identical in both groups.
      Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately
      after close the wound. Perioperative knee photographs in full flexion and extension positions
      were taken and were given to experimental group in the day after surgery. Postoperative knee
      ROM were recorded at day 3, 6 week, 3 month and 6 month. The outcome assessors were blinded
      to treatment groups during the study period.
    

Intervention name(s): Received perioperative photograph; Didn't receive perioperative photograph
Intervention type(s): Procedure; Procedure
Intervention description(s): All participants in experimental group were adviced to see periopertive knee photograph before rehabilitation everyday.
Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
The outcome assessors were blinded to treatment groups.; All participants in active comparator group didn't receive perioperative knee photograph.
Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
The outcome assessors were blinded to treatment groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section
Condition: Spinal Anesthesia; Cesarean Section
MeSH terms: Hypotension
Study type: Observational

Summary: 
      It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness
      of spontaneously breathing patients to fluid therapy. The primary objective of the study is
      to determine the effect of fluid preload applied to patients with preanesthetic FTc values
      below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery.
      Pregnant women who underwent cesarean section under spinal anesthesia were included in this
      prospective study. In the preoperative care unit, patients were assigned to two groups
      according to their baseline FTc values. Patients with baseline FTc < 327 ms were assigned to
      the first group, and Ringer Lactate (RL) preload fluid administration to these patients was
      continued until FTc > 327 ms. On the other hand, patients with baseline FTc > 327 ms were
      assigned to the second group, and preload fluid was not administered to these patients.
      Intraoperative hemodynamic data were recorded for each patient.
    


Intervention name(s): Corrected carotid flow time measurement guided fluid preload
Intervention type(s): Device
Intervention description(s): Preoperative FTcs of pregnant women who underwent C/S operation were measured, and those below the cut-off value (327 ms) determined in previous studies were preloaded with Ringer Lactate until FTc was > 327 ms.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA II pregnant women between the ages of 20 and 40 who were undergoing elective cesarean
        section, and had uncomplicated singleton term pregnancies, and agreed to participate in the
        study were included.
      
Keywords: Cesarean section; Carotid flow time; Preload fluid; Hypotension; Spinal anesthesia
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Condition: Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with
      complicated urinary tract infections and complicated intra-abdominal infections.
    

Detailed description: 
      An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI,
      formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to
      Ceftazidime Resistant Gram Negative Pathogens
    

Intervention name(s): Ceftazidime - Avibactam ( CAZ-AVI); Best Available Therapy; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes; Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation; Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole; Ceftazidime; Avibactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ceftazidime,; avibactam,; metronidazone,; Anti-Infectives
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
Condition: Coronary Artery Disease; Acute Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Thrombosis; Infarction
Study type: Interventional

Summary: 
      To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of
      echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV
      mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.
    

Detailed description: 
      Patients with anterior Q-wave MIs and ejection fractions<=40% will be enrolled within the
      first 4 days of infarction. Patients will be randomized to receive either enoxaparin 1mg/kg
      (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral
      warfarin for 3 months.

      Clinical and safety evaluations, 2-D echocardiograms at baseline and at 3.5 months and cost
      analysis will be performed.
    

Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myocardial Infarction; Left Ventricular Mural Thrombus; Low Molecular Weight Heparin; Enoxaparin; Warfarin; Echocardiograms
Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy
      of chemotherapy in breast cancer precise.

      This real-time noninvasive and feasible imaging technique allows us, the investigators at
      University Hospital Tours, to evaluate early vascular changes of breast tumors during
      treatment. These vascular changes may precede long-term tumoral regression. Imaging of
      primary breast lesions may be of value in the prediction of late treatment response.

      An ultrasound will be performed before the initiation, and after the second and the last dose
      of chemotherapy.

      To investigate the changes occurring in the vascularization of tumors, we will use an
      intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).

      This agent is a microbubbles preparation that is stable, resistant to pressure, and
      specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.
    

Detailed description: 
      The main objective of the study is to evaluate the early vascular changes of the tumor during
      neoadjuvant chemotherapy compared to the clinical or MRI or histological response.
    

Intervention name(s): Contrast-enhanced Ultrasound
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contrast-enhanced Ultrasound; Ultrasound Contrast agents, microbubbles; breast cancer; chemotherapy; vascularization