bioihbjkbjnl/mcl2 huggingface dataset:
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the
      HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects
      with obstructive sleep apnea (OSA).
    


Intervention name(s): HGNS Treatment
Intervention type(s): Device
Intervention description(s): The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; OSA; hypoglossal nerve stimulation; sleep apnea
Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of
      NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled
      trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple
      ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
    


Intervention name(s): NTP42:KVA4; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.; Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Parathyroid Allo-transplantation With a New Technique
Condition: Parathyroid Allo-transplantation
Study type: Interventional

Summary: 
      Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of
      permanent hypoparathyroidism. However, it is a difficult process that requires a number of
      trained staff and advanced laboratory equipment which bring high costs. In this study, we
      have identified a new PA-t technique.
    

Detailed description: 
      Hypoparathyroidism is a clinical problem which is associated with hypocalcemia,
      hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a
      complication of thyroid surgery . Direct injury, ischemia or unintended excision of
      parathyroid tissue are the most common mechanisms that cause temporary or permanent
      hypoparathyroidism. Temporary hypoparathyroidism (<6 months) develops at 10% of cases after
      thyroid surgery and nearly half of them develops permanent hypoparathyroidism (>6 months)
      (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy
      and neck dissection is performed more frequently than before that yields increase in
      frequency of permanent hypoparathyroidism.

      As a current standard treatment, oral or intravenous calcium preparations and active
      vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent
      hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a
      lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no
      beneficial effect on metabolic problems due to PH.

      For these reasons, less costly and effective treatments have been searched over 30 years and
      parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative.
      Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the
      development of immune and inflammatory response against graft tissue which shortens its life
      and impairs the efficacy of the treatment. Various kinds of treatment methods such as
      immunosuppression, microencapsulation and cultivation were tried to overcome this problem.
      Despite these treatment options, convincing results have not yet been achieved . In
      literature, PA-t cases are often presented as case reports, only a few clinical series are
      available .

      In this study, we aimed to present the results of our new PA-t technique that is performed on
      10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no
      benefit from standard medical therapy
    

Intervention name(s): Parathyroid allo-transplantation
Intervention type(s): Biological
Intervention description(s): parathyroid allotransplantation with a new tecnique without immunosuppression
Intervention MeSH terms: Parathyroid Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parathyroid; Permanent hypocalcemia; Transplantation
High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy
Condition: FSHD - Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      The investigators aim to investigate the effect of high-intensity training in patients with
      facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise
      without muscle damage.
    

Detailed description: 
      Clinical trials have in recent years demonstrated that aerobic exercise, are both effective
      and safe in patients with facioscapulohumeral muscular dystrophy. Previous studies have
      tested exercise at moderate intensity. No studies have so far investigated whether
      high-intensity-training (HIIT) exercise can increase fitness, or the training will cause
      muscle damage. However, we know that patients with facioscapulohumeral muscular dystrophy do
      not get increased muscle damage after a single exercise at high intensity.

      Investigators aim to investigate whether patients with facioscapulohumeral muscular disease
      may increase their fitness and improve their functioning in everyday life without muscle
      injury in a time-saving high intensity training.

      To investigate whether HIIT is safe and effective, three groups of participants are included.
      Two training groups, one group of patients and another with healthy matched subjects. The
      training is done on an ergometer-bike three times a week for 8 weeks. One weekly training
      will be supervised. The training consists of an interval training program (10-20-30). The
      third group is a none-training control group of patients. This group will undergo the same
      tests as the two training groups.

      To investigate wether participants would continue HIIT training after 8 weeks of supervised
      training, the two training groups, one group of patients and one group of healthy matched
      subjects, are tested after additional 8 weeks of home based optional training.

      To investigate wether patients with muscular dystrophy facioscapulohumeral will perform
      unsupervised HIIT training and whether it will be as effective as the supervised training,
      the control group of patients who did not train the first 8 weeks, is instructed to do home
      based HIIT for 8 weeks.
    

Intervention name(s): Supervised training; Unsupervised training; Optional training; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.; 8 weeks home based high-intensity-interval cycle-training 3 times a week.; 8 weeks of optional home based, unsupervised training.; 8 weeks of control period. Participants are doing daily living.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: FSHD; HIT; Training; Exercise; 10-20-30 interval training
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 3

Summary: 
      Demonstrate that the vaccine offers protection based on antibody levels in older adults and
      is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
    

Detailed description: 
      Demonstrate that seroconversion by classical Inaba vibriocidal antibody at Day 11 in older
      adults ages 46-64 years (inclusive) was non inferior to seroconversion at Day 11 in younger
      adults ages 18-45 years following vaccination with PXVX0200.
    

Intervention name(s): PXVX0200; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
Condition: Pancreatic Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Study type: Interventional

Summary: 
      To determine the efficacy and safety of robotic, laparoscopic and open surgery for
      enucleation of benign pancreatic neuroendocrine tumors
    

Detailed description: 
      The study was prospective and retrospective, non-randomized study included patients with
      benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent
      robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open
      surgery arms retrospectively include case from the year 2004. The number of patients for
      laparoscopic and open surgery arms are 50 and 100, respectively.
    

Intervention name(s): Robotic surgery; Laparoscopic surgery; Open surgery
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors; Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors; Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
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 pharmacodynamics (PD), pharmacokinetics (PK),
      safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in
      Type 2 diabetes mellitus patients.
    


Intervention name(s): SHR3824; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized and blind clinical consistency study for three commercial batches of Inactivated
      Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
    

Detailed description: 
      This randomized and blind clinical study includes three test groups with 400 infants for each
      group. Sample estimation for this study has been conducted using statistical methods.

      A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3
      different lots with 1 month interval. All subjects received blood collection for
      immunogenicity test before and after primary immunization for evaluation of immunogenicity
      consistency, while safety observation was conducted within 30 days after each vaccination
      (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via
      contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial
      lots.
    

Intervention name(s): sIPV batch 1; sIPV batch 2; sIPV batch 3
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Type I 30 DU, Type II 32 DU, Type III 45 DU; Type I 30 DU, Type II 32 DU, Type III 45 DU; Type I 30 DU, Type II 32 DU, Type III 45 DU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Risk Factors for Postoperative Nausea/Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      General anesthetic technique plays a key role in most surgical procedures. This technique has
      some complications especially postoperative nausea/vomiting (PONV). This complication can
      lead to serious problems. Department of Anesthesiology has developed and implemented a PONV
      prophylaxis guideline for high risk PONV patients but PONV still remains.
    

Detailed description: 
      Objective: To identify risk factors for PONV after implementation of PONV prophylaxis
      guideline.

      Methods: This will be a retrospective analytic study. Relevant clinical data from medical
      records of adult patients undergoing general anesthesia in Srinagarind Hospital from November
      2014 to February 2015 will be used to identify relevant risk factors.
    

Intervention name(s): General anesthesia
Intervention type(s): Procedure
Intervention description(s): Patients undergoing general anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing elective surgery under general anesthesia
Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)
Condition: Duration of Labor
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of our study is to investigate whether the use of obstetric gel shortens the
      first and second stage of labor and exerts a protective effect on the lower genital tract in
      women undergoing a Vaginal Birth After Cesarean (VBAC).
    

Detailed description: 
      Recent literature shows that birth injury is associated with postpartum pelvic floor
      dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor,
      namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal
      sphincter rupture and fecal incontinence. In addition, it is associated with increased
      maternal and neonatal morbidities including increased risk of lower genital tract
      lacerations. In an effort to shorten labor and decrease lower genital tract trauma many
      techniques have been investigated.
    

Intervention name(s): obsteric gel(k-Y jelly)
Intervention type(s): Drug
Intervention description(s): A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson&amp; Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      to evaluate the influence of PRGF treatment on patient suffering from OA knee
    

Detailed description: 
      Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in
      osteoarthritis (OA) capsular joints via multiple mechanisms. Our aim is to examine the effect
      of a platelet-derived preparation rich in growth factors (PRGFs) in OA knee
    

Intervention name(s): PRGF; hyaluronic acid; placebo
Intervention type(s): Biological; Drug; Drug
Intervention description(s): intra auricular injection 6mg; 20 mg / 2 ml; physiological water 3cc + lidocain 3cc
Other intervention name(s): platelet-derived preparation rich in growth factors; Arthrease; seline 0.9% nacl
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to compare the efficacy and safety of EG12014 with
      Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014
      or Herceptin adjuvant treatment for up to 12 months.
    


Intervention name(s): EG12014; Herceptin
Intervention type(s): Drug; Drug
Intervention description(s): EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.; Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic
      inflammatory disease affecting 10% of women. The objective of this study is to compare the
      hemostatic effects of two treatments widely prescribed to women with endometriosis: the
      levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog
      (GnRHa) leuprolide acetate.

      Hypothesis:

      H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is
      alteration in hemostatic system with the use of GnRHa or LNG-IUS
    

Detailed description: 
      Materials and Methods: In this randomized open-label controlled trial, 44 women with
      endometriosis will be randomly allocated to one of two groups: 22 women will be assigned to
      use LNG-IUS and 22 to use GnRHa. The assessed variables will be D-dimers, fibrinogen,
      prothrombin time, activated partial thromboplastin time, coagulation factors (F) II, V, VII,
      VIII, IX, X, and XI, antithrombin (AT), protein C, free protein S, tissue plasminogen
      activator (t-PA), α2-antiplasmin, thrombin-antithrombin complex, and prothrombin fragment
      1+2. All variables will be assessed before treatment and six months after treatment onset.
    

Intervention name(s): LNG-IUS: levonorgestrel intrauterine system; GnRHa: leuprolide
Intervention type(s): Drug; Drug
Intervention description(s): LNG-IUS (levonorgestrel intrauterine system) is inserted until the fifth day of the cycle. It releases 20 mcg/day of LNG; 3.75 mg leuprolide injected intramuscularly on a monthly basis
Other intervention name(s): Mirena; Lupron
Intervention MeSH terms: Leuprolide; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: endometriosis; blood coagulation; levonorgestrel; GnRH agonist; progesterone-releasing intrauterine device
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in
      Chinese female subjects with endometriosis by demonstrating the non-inferiority of
      triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate
      PR 1-month formulation injected 3 times consecutively.
    


Intervention name(s): Triptorelin Pamoate PR 3-month; Triptorelin Acetate PR 1-month
Intervention type(s): Drug; Drug
Intervention description(s): 15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).; 3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
Other intervention name(s): Triptorelin pamoate for injection 15 mg; Diphereline 3.75 mg
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Bone Disease in Older HIV-infected Adults
Condition: Osteopenia; Osteoporosis; HIV Infection; Aging; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases
Study type: Observational

Summary: 
      This study will look to see if there are changes in the blood cells that are associated with
      bone disease and sort out effects that are due to the HIV virus itself, the medications and
      see if faster aging occurs in the cells of HIV infected persons. Bone disease will be
      measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if
      someone has normal bone mass for their age or if there is thinning of the bones.

      The purposes of this study are:

        -  to learn how common bone disease is in HIV infected patients over the age of 50 years
           that receive their care at the CORE Center

        -  to see what are the common causes of bone disease in older HIV infected persons

        -  to see if there are differences in blood cells and levels of cytokines in patients who
           do or do not have bone disease, as this may help researchers determine the cause of bone
           disease.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        100 HIV-infected adults, age 50 years or older, on HAART with undetectable viral loads, who
        are randomly sampled from 6 strata defined by ethnicity (Black:White:Hispanic; 2:1:1) and
        sex (male:female; 1:1).

        100 HIV+ adults, age ≥ 50 yr (50 ♂, 50 ♀; 50 AA, 25 W, 25 H).
      
Biospecimen description: 
      Serum and plasma
    
Keywords: Treatment experienced