bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate safety, tolerability, and pharmacokinetics of
      XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to
      healthy male volunteers
    


Intervention name(s): XG-102
Intervention type(s): Drug
Intervention description(s): single intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Condition: Opiate Dependence; Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to develop an effective psychotherapy for chronic pain and opioid
      dependence.
    

Detailed description: 
      This study aims to develop a novel manualized intervention using tailored
      cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the
      co-occurring disorders of non-malignant pain and opioid dependence (POD).

      Specific Aims:

        1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine
           maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of
           different daily buprenorphine dosages on pain and opiate use.

        2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility,
           acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided
           CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).

      The secondary outcomes: Development of a Treatment Manual and Development and Modification of
      Initial Therapy Training and Process Rating Measures were process measures and not been to be
      included as measures associated with RCT. These outcomes were removed when the RCT results
      were entered. In addition, outcomes were renamed for clarification.

      At results entry, the timeframe (16 weeks) was also corrected to account for the actual
      timeframe used for analysis in the study. The 16-week study period listed in the protocol
      included a 2-week buprenorphine induction period (before randomization) and up to a 2-week
      post-conclusion of the clinical trial continuation on buprenorphine and referral to
      continuing treatment. In prior studies with buprenorphine, the study team had observed an
      artificially high attrition during the last 2 weeks of the planned study protocol, when
      participants were attempting to transition to available clinical treatments outside of the
      study. Consequently, as per the original study protocol for this study, the plan was to
      analyze intake and induction data (as baseline data) and then the data from the first
      12-weeks post-randomization.
    

Intervention name(s): CBT; Buprenorphine; Educational Counseling; Physician Management
Intervention type(s): Behavioral; Drug; Other; Other
Intervention description(s): Cognitive behavioral therapy; buprenorphine/naloxone; Didactic, lecture-discussion format to supplement information and advice provided by physicians; Brief physician counseling
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heart Healthy Lenoir: Return of Results Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators are conducting a two group intervention to study to the effect of
      individualized heart disease genomic risk results on motivation towards diet and physical
      activity behaviors to reduce heart disease risk. The intervention includes provided
      participants with genomic and lifestyle risk estimates. Investigators will follow
      participants for 3 months to determine if motivation towards and engagement in diet and
      physical activity behaviors change.
    


Intervention name(s): Return of genomic results on cardiovascular disease risk
Intervention type(s): Behavioral
Intervention description(s): Experimental group: Participants will receive genomic cardiovascular disease risk information.
Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Return of results; Genomics
Thromboelastographic Guide for Blood Products in Cirrhotics
Condition: Liver Cirrhosis; Coagulation Disorder
MeSH terms: Liver Cirrhosis; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Blood products are commonly used before invasive procedures in patients with end-stage liver
      diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely
      INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive
      procedures and in representing the real coagulation status of cirrhotic patients.
      Notwithstanding they are still used to guide blood products administration before invasive
      procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of
      hypo-hypercoagulability possibly being an alternative method to guide blood products
      transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG
      as a guide for blood products transfusion in cirrhotic patients undergoing invasive
      procedures.
    


Intervention name(s): Thromboelastography to guide blood products infusion; Standard of care coagulation tests to guide blood products infusion
Intervention type(s): Procedure; Procedure
Intervention description(s): A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm; Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Atorvastatin; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of atorvastatin.
    


Intervention name(s): Isavuconazole; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557
Intervention MeSH terms: Isavuconazole; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Atorvastatin; Healthy Volunteers; BAL8557; BAL4815; BAL8728
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions
      surgical technique compared to conventional surgical technique. Specifically, the purpose of
      this study is to collect time data to enhance the existing economic model.
    

Detailed description: 
      The study is designed as a prospective, multi-center, controlled, non-randomized, clinical
      investigation to compare the efficiency of TruMatch® Personalized Solutions surgical
      technique compared to conventional surgical technique.
    

Intervention name(s): Custom Patient Instrumentation; Conventional Instruments
Intervention type(s): Other; Other
Intervention description(s): TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon; Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
Other intervention name(s): TruMatch® Personalized Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthroplasties, Knee Replacement; Arthroplasties, Replacement, Knee; Arthroplasty, Knee Replacement; Knee Replacement Arthroplasties; Knee Replacement Arthroplasty; Knee Replacement, Total; Replacement Arthroplasties, Knee; Replacement Arthroplasty, Knee; Replacement, Total Knee; Total Knee Replacement
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
Condition: Malunion of Fracture of Clavicle; Delayed Union of Fracture of Clavicle
MeSH terms: Fractures, Bone; Fractures, Malunited
Study type: Observational

Summary: 
      Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The
      current method of treatment for these fractures is non-operative management. There is recent
      Level 1 evidence in the adult literature to suggest that outcomes are superior when these
      fractures are managed surgically with open reduction and internal fixation.
    

Detailed description: 
      The study is a prospective observational cohort design of the natural history of adolescent
      clavicle fractures treated at the McGill University Health Centre. Surgeon choice will
      dictate treatment. There is no difference from the current normal therapy choice of each
      individual surgeon. Patients will be offered either operative or conservative management.

      Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered
      operative treatment which involves open reduction and internal fixation with a plate. This is
      the standard treatment for completely displaced fractures in the adult population at our
      Institution based on Level 1 evidence.

      Conservative care: Patients will be treated in a sling for the acute phase of two weeks with
      progressive physiotherapy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents (ages 12 to 18) who have a displaced clavicle fracture
      
Keywords: prospective; adolescent; displaced; clavicle; fracture; mid-shaft
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, Phase I, single-center, single-dose administration study to determine
      the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and
      to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A
      and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part
      A and dosing the first subject in Part B. In each part, 6 healthy female subjects of
      non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.
    


Intervention name(s): GDC-0449 oral capsules (non-labeled); GDC-0449 IV injection (labeled); CDC-0449 oral suspension (labeled)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg oral capsule; 10 mcg (in 2 mL) IV dose of 14C-GDC-0449; 30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GDC0449
Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment
Condition: Anti-anxiety Agents; Moderate Sedation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess the efficacy of Dexmedetomidine drug either used
      sublingually or intranasally in managing healthy children during dental treatment
    

Detailed description: 
      Each child should fulfill the requirements of having a dental condition which needs treatment
      in two dental sessions, where each session should not exceed thirty minutes. At the first
      visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second
      visit the alternate route will be implemented in a cross-over design. At least one week
      interval between the two visits will be secured.
    

Intervention name(s): Intranasal Dexmedetomidine; Sublingual Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.; The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control
Masking: None (Open Label)
Primary purpose: Treatment
Complementary and Alternative Medicine (CAM) for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study is an acceptability and feasibility study of two adjunctive interventions: group
      education with stretching; and group acupuncture. The study population will be women with
      primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both
      interventions will be 10 weeks in length and will be conducted at the Oregon Health & Science
      University. The primary hypothesis is that both arms will be acceptable and feasible in the
      study population.
    


Intervention name(s): Group Education and Stretching; Group Acupuncture
Intervention type(s): Behavioral; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Group Acupuncture; Group Education with Stretching; Nociceptive Reflex Testing; Pain; Sleep; Fatigue
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the efficacy and safety of SPARC1310 when compared to placebo and
      active control
    


Intervention name(s): SPARC Placebo; SPARC1310 I; SPARC1310 II; SPARC1310 III
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; SPARC1310 I; SPARC1310 II; SPARC1310 III
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Behaviour Therapy for Patients With IBS
Condition: Irritable Bowel Syndrome; Constipation; Abdominal Pain; Depression
MeSH terms: Irritable Bowel Syndrome; Constipation; Abdominal Pain
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This
      condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and
      reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy,
      hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT
      in IBS patients in Israel are scarce.

      The aim of the present study is to assess effectiveness of CBT as compared with standard
      therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions,
      and included education about IBS and techniques to reduce focusing on symptoms and to manage
      stress.Standard therapy includs life style modifications.

      The primary outcome measure was the score on a symptom-severity scale specific to IBS.
    

Detailed description: 
      Symptomatic treatment of patients would not be modified
    

Intervention name(s): Diet modifications; Cognitive behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diet consultation; Cognitive behavioral therapy
Other intervention name(s): Diet; CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructed constipation; Quality of life
Surfactant Protein Genetic Variants in COVID-19 Infection
Condition: Coronavirus Infection
MeSH terms: Infections; Communicable Diseases; Coronavirus Infections
Study type: Observational [Patient Registry]

Summary: 
      Surfactant protein plays important role in innate immunity against respiratory viral
      infections. However, investigators have shown that the surfactant protein polymorphisms are
      associated with severity of various pulmonary diseases such as respiratory syncytial virus
      (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the
      respiratory system and responsible for death due to acute respiratory failure. There is a
      considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients
      to severe infection requiring intensive care and some may die. Considering reports of
      COVID-19 related deaths/severe disease in the same family, it is possible that genetics play
      an important role in severity of COVID-19 infection. Investigators propose to study the
      association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize
      genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To
      determine if there is a correlation between certain genetic markers and the severity of
      COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers
      with immune studies.
    


Intervention name(s): Identification of genetic variants
Intervention type(s): Other
Intervention description(s): DNA will be extracted from whole blood from study subjects
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with positive COVID-19 infection will be enrolled regardless of age and sex after
        obtaining informed consent.
      
Biospecimen description: 
      DNA will be stored for the future studies.
Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
Condition: Rectocele; Obstructive Defecation Syndrome
MeSH terms: Rectocele
Study type: Interventional

Summary: 
      The ideal surgical strategy for treating complex rectocele remains a topic for debate, with
      the transanal, transperineal, and transvaginal approach and the abdominal approach being at
      conflict with one another. While the transvaginal repair is more popular among gynecologists,
      the trans abdominal approach has become increasingly common among colorectal surgeons, in
      part due to the rising demand for minimally invasive surgery.
    

Detailed description: 
      For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come
      to light as a promising alternative.

      Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of
      rectal prolapse. However, It was also recommended with encouraging results for the treatment
      of large symptomatic rectocele.

      The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.
    

Intervention name(s): laparoscopic ventral mesh rectopexy
Intervention type(s): Procedure
Intervention description(s): patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anterior rectocele; laparoscopic ventral mesh rectopexy
Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical
Condition: Infectious Disease; Tropical Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Direct constitution of collections from various samples taken on a prospective cohort of
      healthy volunteers, to prepare human biological samples of known characteristics (biochemical
      and serological in particular) and quality controlled.
    

Detailed description: 
      Direct constitution of collection from various samples taken on a prospective cohort of
      healthy volunteers, to prepare human biological samples of known characteristics (biochemical
      and serological in particular) and quality controlled.

      This collection will allow, as a priority, a development stage, ie the establishment of the
      proof of concept of new diagnostic methods in the field of infectious and tropical diseases.

      There will be 2 cohorts (= arms) for this study: the main cohort of healthy volunteers and
      the N cohort, which will consist of patients with neuro-meningeal disease of infectious
      appearance and followed in specialized consultation.
    

Intervention name(s): biological samples; lumbar puncture
Intervention type(s): Biological; Procedure
Intervention description(s): collection of blood, urine, saliva, stool, skin and mouth swabs, tears; collection of cerebrospinal fluid
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: sample; diagnostic
Somatic Symptoms in Autism Spectrum Disorder: Data Integration
Condition: Autism Spectrum Disorder; Somatic Symptom Disorder
MeSH terms: Medically Unexplained Symptoms; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more
      health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular
      disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter
      than non-autistic patients. Furthermore, autistic patients are not able to convey or
      communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable
      to receive proper health care in a timely manner.
    


Intervention name(s): No intervention involved
Intervention type(s): Other
Intervention description(s): No intervention involved
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        as mentioned earlier, it is a retrospective study with existed data. Therefore, the 1423
        participants are already collected in the past. We separate these existed data into three
        groups as mentioned in the eligibility criteria