bioihbjkbjnl/mcl2 huggingface dataset:
Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome
Condition: Somatisation Disorder; Somatoform Disorders
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in
      patients with longlasting health problems with no known medical explanation, defined as
      multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS
      have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing
      both pain and other symptoms of bodily distress for patients with BDS. Control conditions are
      pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13 weeks,
      i.e. after 10 weeks of 25-75 mg study drug.
    

Detailed description: 
      The aim of this study is to test the effect of Imipramine in patients with multi-organ Bodily
      distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely
      related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and
      chronic fatigue syndrome. The project consists of a double-blinded placebo controlled trial
      of treatment with the tricyclic antidepressant Imipramine in dosages of 25-75 mg. Primary
      outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I).
      Secondary outcome is functional level (physical, mental and social) measured by the SF-36
      Physical Component Summary (PCS). The study requires 140 participants and study duration is
      19 weeks for each patient. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.
    

Intervention name(s): Imipramine treatment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.; Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bodily Distress Syndrome; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Treatment; Imipramine; Tricyclic antidepressant
Fatigue in Rheumatoid Arthritis - Longitudinal Study
Condition: Fatigue; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Fatigue
Study type: Observational

Summary: 
      To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and
      which factors that may influence the fatigue.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg,
        Sweden
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
Condition: Uterine Fibroids; Endometriosis
MeSH terms: Leiomyoma; Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with
      moderate to severe renal impairment compared with matched subjects with normal renal
      function.
    

Detailed description: 
      This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups
      of subjects with moderately or severely impaired renal function or normal renal function
      matched with regard to sex, age, race and weight. PK blood and urine sampling for
      determination of vilaprisan concentrations in plasma and urine, respectively, will be
      preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be
      assessed through adverse events, clinical laboratory tests, vital signs, 12-lead
      electrocardiograms and physical examinations.
    

Intervention name(s): Vilaprisan (BAY1002670)
Intervention type(s): Drug
Intervention description(s): Single oral dose (1 x 2 mg immediate-release, film-coated tablet)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics
Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and
      efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in
      subjects with refractory or relapsed CD20+ B-cell lymphoma.
    


Intervention name(s): ACTR087; rituximab
Intervention type(s): Biological; Biological
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD20+; B-cell; ACTR087; Relapsed; Refractory
Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, Phase One, multicenter study, designed to evaluate the safety,
      tolerability, to explore the biologic effects, and to explore the clinical effects of the
      following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day
      orally for 24 weeks in patients with IPF.
    

Detailed description: 
      IW001 is a therapeutic designed to treat anti-Col (V)-mediated autoimmune diseases via oral
      tolerance. With the identification of the specific antigen involved in the autoimmune disease
      process in IPF, IW001 induced oral tolerance may be an effective treatment. IW001 is taken
      orally, introduced into the mucosal immune system at the Peyer's Patches in the distal small
      intestine, where antigen-presenting cells present the antigen to regulatory T cells (Tregs).
      These antigen-specific Tregs enter the blood stream and traffic to areas where the specific
      antigen has generated an autoimmune response. Thus, IW001 may produce selective suppression
      of immune responses against Col (V).
    

Intervention name(s): IW001
Intervention type(s): Drug
Intervention description(s): IW001, 0.1 mg, 0.5 mg, 1.0 mg PO daily for 24 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety, biologic effects, IPF, autoimmune
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty
Condition: Aging Frailty
MeSH terms: Frailty
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical study is to answer the questions:

        1. Is the proposed intervention safe?

        2. Is the proposed intervention effective in improving the healthy status of subjects with
           aging frailty?
    

Detailed description: 
      Aging frailty is a clinical syndrome, characterized by a decrease of homeostatic reserves and
      enhanced vulnerability to endogenous or exogenous stressors, exposing individuals to an
      increased risk of adverse health-related outcomes. The human umbilical cord (HUC) is a
      promising source of mesenchymal stem cells (MSCs), compared to embryonic stem cells, HUC-MSCs
      are noncontroversial with a painless collection procedure and faster self-renewal properties.
      HUC-MSCs can differentiate into the different germ layers and modulate immune responses. One
      possible mechanism for the onset and development of aging frailty is the depletion of stem
      cells. Hence, intravenous infusion of HUC-MSCs is attractive therapy against aging frailty.

      This is a randomized, double-blind, placebo-controlled clinical trial. The participants (n =
      30) will be randomly distributed into two groups. The HUC-MSCs Group (n = 15) will receive
      intravenous infusion of mesenchymal stem cells twice over a month (30 days interval), the
      Control Group (n = 15) will receive the same protocolized intervention with normal saline.
      Follow-up duration is 6 months after first intervention. The reported serious adverse
      events（SAEs）will be observed within one month post infusion. The short-item from health
      survey（SF-36), EuroQol five dimensions questionnaire (EQ-5D) and Fried phenotype scale will
      be evaluated. Short physical performance battery (SPPB) and plasm biomarkers will be
      assessed.The assessments will be performed at baseline, 1 month, 3 months and 6 months.

      The intent of this study is to explore domains of efficacy of HUC-MSCs through the reduction
      of signs and symptoms of aging frailty and to evaluate the safety of HUC-MSCs in subjects
      with aging frailty.
    

Intervention name(s): Human umbilical cord mesenchymal stem cells（HUC-MSCs）; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Human umbilical cord mesenchymal stem cells（HUC-MSCs）; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Recolonisation of Bacteria in Hands and Possible Bacterial Leakage From Glove Cuff in Cardiac Surgery
Condition: Bacterial Growth
Study type: Interventional

Summary: 
      This study aims to investigate if recolonisation of the hand flora occur after surgical hand
      washing and is there a bacterial leakage at the glove cuff site in cardiac surgery? Also
      investigate if thera are differences in microbial flora and recolonisation between hospital
      and non-hospital persons.
    

Detailed description: 
      With emerging antibiotic resistant bacteria it is necessary to try to prevent surgical site
      infections (SSIs).Not only because of suffering and death but also because of increased
      costs. For a deep sternal infection the cost can be doubled or even tripled. Sternal wound
      complications can occur from low numbers up to almost 10%, with different severity, depending
      on follow up routines In an intraoperative environment causative bacteria often originate
      from either patient or surgical team. One of many preventing measures is to keep patients and
      surgical members as sterile as possible when it´s the number of bacteria that overcome the
      host defense that lead to infection. The most common bacteria causing sternal infection is
      Coagulase negative staphylococci (CoNS) 46% Staphylococcus aureus, 26% and gram- negative
      bacteria, 18%. One preventing measure is to wear surgical gloves, and to wear double gloving
      for easy detection of puncture in outer glove. When using indicator gloves there becomes a
      dark spot were the hole is which tells you to change the glove. At the glove cuff end it
      often indicate fluid of some sort by getting dark where the sleeve of the gown meets the
      glove cuff. One may suspect that the fluid thrives from the hand, and if so does the fluid
      contains any bacteria from the hands. In open heart surgery surgical team wear their gloves
      for a long period of time. Research implicates that it occurs some recolonisation of bacteria
      inside the gloves. Does recolonisation of the hand flora occur after surgical hand washing
      and is there a bacterial leakage at the glove cuff site? It´s discussed that people that are
      in contact with hospitals carries more bacteria than others and being admitted to hospital
      before surgery is a risk factor. It is also known that hospital workers are carriers of more
      bacteria and possibly also carriers of resistant bacteria. At the other hand hospital workers
      often wash and disinfect their hands. Are there differences in bacterial recolonization of
      hand flora between hospital staff at an operating department than people in average society
      who have little or no contact with hospitals?
    

Intervention name(s): Surgical hand disinfection.
Intervention type(s): Procedure
Intervention description(s): Bacterial recolonization
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy
Condition: Intubated Patients
Study type: Interventional

Summary: 
      Abstract Background: A number of patients referring to the emergency departments (EDs) due to
      airway obstruction or decreased level of consciousness require the establishment of a
      definite airway using intubation. On the other hand, performing Nasogastric tube (NGT)
      insertion is very challenging in anesthetized and intubated patients. And, a conclusive
      method has not yet been presented in this regard. Hence, the current study aimed at comparing
      Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.

      Materials and Methods: The present clinical trial was performed on 76 intubated patients that
      were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and
      Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of
      attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients'
      satisfaction level were recorded and examined in this study.
    


Intervention name(s): Digital Intubation (Two-finger); Video Laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.; In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Digital Laryngoscopy; Endotracheal Tube; Nasogastric Tube (NGT); Video Laryngoscopy
Postoperative Analgesic Effect of Esketamine
Condition: Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor; Analgesia
MeSH terms: Dystocia
Study type: Interventional

Summary: 
      The aim of this study was to determine whether the addition of esketamine to morphine would
      improve postoperative analgesia after caesarean section.

      Parturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia
      with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C
      and D). When the surgery was completed, the parturients in groups A, B, C and D were
      administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg
      morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural
      catheters, respectively. The postoperative pain at rest, pain with movement, the number of
      rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.
    


Intervention name(s): 2 mg morphine sulfate; 0.25mg/kg esketamine; 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate; 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.; The parturients were administered 0.25mg/kg of esketamine through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.; The parturients were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.; The parturients were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.
Intervention MeSH terms: Morphine; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma
Condition: Chronic Lymphocytic Leukemia; Lymphoma; Multiple Myeloma
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan
      Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
    

Detailed description: 
      Treatment plan

        -  Conditioning chemotherapy before infusion of allogeneic stem cells will include
           fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2
           at day -2.

        -  Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.

        -  Melphalan will be administered following the completion of Fludarabine infusion at day
           -2.

        -  In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5
           mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4,
           -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po.
           Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before
           thymoglobulin (or lymphoglobuline) on days -4 to -2.

        -  Before the administration of melphalan, prehydration will be done intravenously with
           0.9% NS 1L over 3 hours.

        -  30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan
           1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push
           every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.

        -  Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days.
           Appropriate amount of KCl should be mixed.

        -  GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.
    

Intervention name(s): Flu-Mel
Intervention type(s): Drug
Intervention description(s): Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
Melphalan will be administered following the completion of Fludarabine infusion at day -2.
Other intervention name(s): Fludara-Alkaran
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose inpatient and outpatient study to test whether an effect on the ability
      of platelets to stick to white blood cells in subjects who smoke.
    


Intervention name(s): PSI-697; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: healthy subjects who smoke; healthy subjects
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 in Healthy Subjects
Condition: Skeletal Muscle Relaxation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, dose-escalation study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate
      the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and
      pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
    


Intervention name(s): HRS3797; HRS3797; HRS3797
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HRS3797 for injection, low dose; HRS3797 for injection, medium dose; HRS3797 for injection, high dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: HRS3797 for dose escalation
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction
Condition: Aging Problems; Wrinkle
Study type: Interventional

Summary: 
      This study was aimed to compare the effectiveness of polydioxanone thread embedding
      acupuncture and manual acupuncture on the reduction of the nasolabial fold. One cycle of
      therapy in the manual acupuncture group (MA) was carried out with 6 sessions of manual
      acupuncture therapy while one cycle of therapy in the thread embedding acupuncture group
      (TEA) received 1 single session of thread embedding acupuncture. The outcome of the study was
      assessed based on the length of the nasolabial fold as measured by a digital vernier caliper,
      changes in wrinkle severity rating scale, and patient's subjective opinion of her nasolabial
      fold using visual analog scale. Outcome measurements were carried out after completing 1
      cycle, and follow up at 2 weeks, 1 month, 2 months and 3 months after completing 1 cycle.
    


Intervention name(s): Manual acupuncture; Thread embedding acupuncture
Intervention type(s): Other; Other
Intervention description(s): Manual acupuncture using filiform needle; Thread Embedding acupuncture using Polydioxanone thread
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Acupuncture; Thread embedding acupuncture; Aesthetic