bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, non-blinded randomized phase III trial. Patients will be
      post-surgically stratified at inclusion first according to the participating institution,
      then according to menopausal status and will be randomly assigned to receive either:

        -  TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks
           (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500
           mg/m2 as an i.v. bolus on day 1 every 3 weeks.

        -  FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination
           with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v.
           bolus on day 1 every 3 weeks.
    

Detailed description: 
      Primary objective:

        -  To compare disease-free survival (DFS) after treatment with docetaxel in combination
           with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with
           doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable
           breast cancer patients with negative axillary lymph nodes.

      Secondary objectives:

        -  To compare overall survival (OS) between the 2 above mentioned arms.

        -  To compare toxicity and quality of life between the 2 above mentioned arms.

        -  To evaluate pathologic markers for predicting efficacy (hormonal receptors and human
           epidermal growth factor receptor 2 (HER2) protein expression).
    

Intervention name(s): Docetaxel; 5-fluorouracil; Doxorubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Taxotere; Adrucil; adriamycin; cytoxan
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High risk node negative breast cancer; Disease-Free survival; Quality of life
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
Condition: Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Lung Diseases, Obstructive
Study type: Interventional

Summary: 
      The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic
      respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system
      will accomplish this by providing oxygen under pressure and augmenting the subject's
      spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted
      ventilation, and a comfortable low-profile device, will result in a mean improvement in
      perceived well-being and ability to perform ADLs, as measured by patient-reported outcome
      (PRO) instruments.
    

Detailed description: 
      This will be a prospective, open-label, crossover study in up to 12 stable subjects with
      chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy
      will be used as the control treatment and compared to the test ventilator system during
      selected activities of daily living. Subjects will participate in the study for up to 9 home
      visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting
      approximately 1-2 hours each. Subjects may discontinue study participation at any time.
    

Intervention name(s): NIOV System; Standard Oxygen Cannula
Intervention type(s): Device; Device
Intervention description(s): Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.; Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
Other intervention name(s): NIOV; Oxygen; O2; Cannula
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Management of Severe Congenital Blepharoptosis
Condition: Blepharoptosis
MeSH terms: Blepharoptosis
Study type: Interventional

Summary: 
      Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients
      with severe congenital ptosis.
    

Detailed description: 
      Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital
      ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the
      success rate and if there is any postoperative complications.
    

Intervention name(s): Ptosis surgery
Intervention type(s): Procedure
Intervention description(s): Frontalis sling surgery using pose-up and Wright's fascia-lata needle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: COVID-19; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.)
      administered once monthly can develop an adequate immune response to the COVID-19 mRNA
      vaccine compared to participants on an interferon or glatiramer acetate.
    

Detailed description: 
      This is a six-cohort, multicenter, prospective study of up to 88 relapsing MS participants.
      The first cohort will be participants receiving an mRNA COVID-19 vaccine at least two weeks
      prior to ofatumumab start. The second cohort will be participants receiving an mRNA COVID-19
      vaccine at least four weeks after beginning ofatumumab. The third cohort will be participants
      currently on an interferon or glatiramer acetate planning to receive COVID-19 mRNA vaccine.
      The fourth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine at least
      four weeks after ofatumumab start. The fifth cohort will be participants fully vaccinated
      with an RNA COVID-19 vaccine, with or without a booster dose, and currently on interferon or
      glatiramer acetate. The sixth cohort will be participants fully vaccinated with an RNA
      COVID-19 vaccine and received a booster dose at least four weeks after ofatumumab start.
      Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or
      appropriate federal, state or local program.
    

Intervention name(s): Ofatumumab; mRNA COVID-19 vaccine; interferon or glatiramer acetate
Intervention type(s): Drug; Biological; Drug
Intervention description(s): 3 loading doses followed by monthly administrations; Pfizer or Moderna mRNA Vaccine; iDMT
Intervention MeSH terms: Interferons; Ofatumumab; Glatiramer Acetate; (T,G)-A-L
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing Multiple Sclerosis; COVID; COVID-19; Vaccine; Coronavirus; adult; OMB157
Bioequivalence Study of Letrozole 2.5 mg Tablets
Condition: Healthy
Study type: Interventional

Summary: 
      Bioequivalence
    

Detailed description: 
      The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets
      after administration of single doses to normal healthy Korean subjects under fasted
      conditions.
    

Intervention name(s): Femara (Sequence 1); Peratra (Sequence 1); Femara (Sequence 2); Peratra (Sequence 2)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.; Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.; Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.; Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
Other intervention name(s): Femara Tab.[Letrozole 2.5mg]; Peratra Tab.[Letrozole 2.5mg]; Femara Tab.[Letrozole 2.5mg]; Peratra Tab.[Letrozole 2.5mg]
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Subjects
Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh
Condition: Contraception; Post-abortion; Abortion
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether a mobile phone intervention can be effectively
      used to improve post menstrual regulation contraceptive uptake and continuation in
      Bangladesh.

      The study will consist of two phases: Phase I: A formative phase to understand barriers to
      post-abortion contraceptive uptake and continuation and the content and modality of messages
      most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test
      the effectiveness of the mHealth intervention developed during the formative phase on
      contraceptive use.
    

Detailed description: 
      The proposed study aims to develop and evaluate a mHealth intervention to promote
      post-abortion contraceptive uptake and continuation among menstrual regulation clients in the
      Sylhet, Chittagong and Dhaka regions of Bangladesh.

      The aim of the formative phase of the study is to develop an interactive two-way messaging
      service for post-MR clients. The messaging service will deliver information relating to the
      women's contraceptive method of choice as well as information about other modern
      contraceptive methods. This part of the study will focus on determining the modality,
      content, timing, language and acceptability of messaging services for post menstrual
      regulation clients.

      The aim of the RCT phase is to measure the effect of mHealth on uptake or switching to
      long-acting reversible contraceptives at the 4 month and 12 month follow ups. The
      investigators expect mHealth to have a positive effect on uptake and a negative effect on
      discontinuation rates of contraceptive users.
    

Intervention name(s): Mhealth intervention
Intervention type(s): Behavioral
Intervention description(s): A series of ten automated interactive voice messages will be delivered to the participant's mobile phone over a period of 4 months. Messages will be targeted to the method of contraception the participant is using (no-method, condoms, pills, injectable, implant, copper coil). Messages will support uptake of contraception among no-method users. Messages will support existing users to continue their method and to use it correctly and will also encourage participants who are not happy with their method to switch to a different method. All messages will end with five options: Press 1 to repeat the message, press 2 to listen to recorded information about methods of contraception, press 3 to speak to a counsellor, press 4 to tell me you're fine, press 5 to stop receiving these messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Family Planning; Abortion; mHealth; Behaviour Change Communication; Menstrual Regulation; Postabortion; Bangladesh
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes
      mellitus and healthy adults.
    


Intervention name(s): DSP-8658; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily; Placebo 2.5, 10, 20, 40 mg orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes
P4 Approach in Diabetes Type 2
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The study aims to assess the impact of the P4 approach on established markers of glucose
      metabolism in type 2 diabetics.

      Secondary objectives are examination of the changes in physical characteristics, quality of
      life and the indices for beta cell function, hepatic insulin resistance and muscle insulin
      resistance .
    

Detailed description: 
      This study will be a proof-of-principle exploratory study. Subjects in the P4 program will
      receive a personalized diagnosis and treatment. After investigation of the status of the
      different organs involved in diabetes (liver, muscle, pancreas), subjects in the P4 group are
      divided into 3 subgroups. Each subgroup receives a personalized lifestyle advice. This
      lifestyle advice may comprise different interventions, i.e. very low calorie diet, low
      calorie diet, strength training, endurance training. Dependent on the type of intervention,
      these interventions will be supervised by a dietitian or physiotherapist.

      All subjects will visit a central study center 5 times during the study and 3 times during
      follow-up. During these visits physical measures will be taken and data will be collected by
      the general practitioner assistant.

      After the three month intervention period the subjects will return to usual care via the
      general practitioner.
    

Intervention name(s): Intervention A: Diet; Intervention B: Exercise; Intervention C: Diet and Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice; subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.; subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
Other intervention name(s): very low calorie diet based on Modifast meal replacers.; very low calorie diet based on Modifast meal replacers.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: personalized treatment; prevention; improved diagnosis
VDR SNPs & 25OHD Correlated With Dyslipidemia
Condition: Dyslipidemias; Single Nucleotide Polymorphism
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs)
      of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating
      25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in
      the associations.
    


Intervention name(s): No intervention.
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adult volunteers visiting a health examination center in Shenzhen city of Guangdong
        province, China were recruited.

        A total of 1,987 adults were included in the analysis, aged from 20 to 81 years old. Among
        them, there were 1,124 females aged 39 (31 - 49) years old and 863 males aged 36 (30 - 44)
        years old.
      
Biospecimen description: 
      Blood samples were collected for plasma or serum and DNA isolations.
    
Keywords: gene polymorphism; vitamin D receptor; vitamin D; lipid; dyslipidemia
FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)
Condition: Chronic Total Occlusion of Arteries of the Extremities
Study type: Interventional

Summary: 
      This study is to assess the safety and efficacy of the FastWire System. It is intended to
      assess that the FastWire System can facilitate the intra-luminal placement of conventional
      guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
    

Detailed description: 
      A first-in-human, single-arm, single-center, feasibility study to assess the efficacy and
      safety of the FastWire System in patients who have a chronic total occlusion in their
      peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 10
      patients meeting the inclusion/exclusion criteria.
    

Intervention name(s): FastWire System Device - Peripheral
Intervention type(s): Device
Intervention description(s): The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Total Occlusion; Peripheral; CTO; FastWire System; FastWire Guidewire; intra-luminal; Active wire; Procedure; Device
Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder
Condition: Acute Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      After a traumatic event such as an accident or an assault, victims may experience intense
      stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a
      frequent and serious pathology, which can be complicated by depression, addiction or suicide.
      Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is
      an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the
      vicious circle of stress and prevent the development of the disease. The objective of this
      study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an
      emergency department after trauma.
    


Intervention name(s): Prazosin, ALPRESS® LP 2,5 et 5 mg
Intervention type(s): Drug
Intervention description(s): Patients will take Prazosin during 28 days ; there are two periods of treatment (escalation of doses):
PERIOD 1 (Day 0 - Day 7): 1 tablet of ALPRESS LP 2.5 mg (Prazosin) at bedtime for 7 days
PERIOD 2 (Day 8 - Day 27): 1 morning tablet of ALPRESS LP 5 mg (Prazosin) at bedtime for 21 days.
Intervention MeSH terms: Prazosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute stress Disorder; Post Traumatic Stress Disorder; Prevention; trauma; prazosin
Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional
      capacity, peripheral muscle strength and quality of life. Despite the high incidence and
      severity has not yet been demonstrated whether a physical training program can change these
      outcomes. Objectives: To evaluate the effects of an exercise training program in patients
      hospitalized for CAP, to compare this effects with traditional physical therapy and assess
      whether the inflammatory markers correlate with the functional status of the patient and type
      of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients
      hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will
      be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk
      test, Glittre test, measurement of peripheral muscle strength, spirometry, and the
      application of quality of life questionnaire Shor Form 36 will be held. The measurement of
      inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held.
      Patients will be randomized into two groups: one will perform a program of physical training
      (stretching, active resistance exercises and aerobic exercises) and the other group held the
      traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight
      days. On the tenth day the same assessment will be carried out initially described.
    


Intervention name(s): Experimental group; Control group
Intervention type(s): Other; Other
Intervention description(s): Exercise Training Group; Exercise control group
Other intervention name(s): -heating: exercise of free movement of upper and lower limbs; -stretching: stretching various muscle groups; -cardio training walk: 15 minute walk with a high speed; -peripheral muscle strength: exercises using Theraband (R); -chest percussion: manual chest percussion; -vibrocompression: manual therapy to the chest; -cough: request for coughing; -breathing exercises: exercises for lung expansion; -Walk: 15 minutes of light walking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment