bioihbjkbjnl/mcl2 huggingface dataset:
Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors
Condition: Cancer Survivor; Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the
      well-being and quality of life of cervical cancer survivors.

      PURPOSE: This randomized clinical trial is studying how well psychosocial support works in
      African-American, Latina-American, or European-American cervical cancer survivors.
    

Detailed description: 
      OBJECTIVES: I. To evaluate the utility of the 6 telephone sessions (low intensity: LiTx) and
      8 telephone sessions (high intensity: HiTx) plus Survivorship Booklet designed to educate and
      improve awareness of the physical and psychological impact of cancer and increase knowledge
      of appropriate medical and psychosocial resources for women with cervical cancer. II. To
      evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve
      psychological functioning (decrease depression and anxiety) of women with cervical cancer.
      III. To evaluate the utility of the telephone sessions (LiTx and HiTx) designed to improve
      social functioning (family support and communication).

      OUTLINE: Patients are clinically assigned to 1 of 2 groups. GROUP I: Patients receive a
      survivorship booklet in the mail that contains information about cervical cancer. Patients
      then receive a follow-up telephone call at 3 months to clarify any issues relevant to the
      survivorship booklet. GROUP II: Patients are randomly assigned to receive either 6 or 8
      weekly telephone sessions that address managing medical issues, health education, and cancer
      resources; balancing emotions and managing stress; coping skills and problem solving; family
      and social concerns; relational, intimacy, and sexual concerns; and financial and employment
      concerns. Patients also receive a survivorship booklet as in group I.
    

Intervention name(s): telephone-based intervention; counseling intervention; questionnaire administration; study of socioeconomic and demographic variables; psychosocial assessment and care
Intervention type(s): Behavioral; Other; Other; Other; Procedure
Intervention description(s): Either 6 or 8 telephone educational sessions; counseling and communications studies; Ancillary studies; Ancillary Studies; 6 weeks or 8 weeks of psychoeducational telephone sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: psychosocial effects of cancer and its treatment; stage IA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; cancer survivor
Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
Condition: Ovarian Cancer; Testicular Germ Cell Tumor
MeSH terms: Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating
      patients with refractory metastatic germ cell tumors that have not responded to surgery or
      chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration
      of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the
      toxic effects of this regimen in these patients.

      OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30
      minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of
      six courses in the absence of unacceptable toxicity or disease progression. Patients are
      followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

      PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
    

Intervention name(s): gemcitabine hydrochloride; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Gemcitabine
Primary purpose: Treatment
Keywords: stage III malignant testicular germ cell tumor; recurrent malignant testicular germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
Condition: Bipolar Disorder; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Bipolar Disorder; Alcohol Drinking
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will conduct a 12-week, randomized, double-blind, parallel-group,
      placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and
      bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess
      change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include
      change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric
      symptoms (mania/hypomania and depression) and predictors of response will be assessed.
      Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase
      with an upward titration to 30 mg/day for those in the active treatment group. The placebo
      group will remain on placebo.

      Subjects will be discontinued from the study if any of the following conditions occurs:
      change in diagnosis to other than bipolar I or II disorder and AUD, development of active
      suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the
      opinion of the investigators requires discontinuation, pregnancy, development of severe or
      life-threatening medical condition, involuntary psychiatric hospitalization or incarceration,
      significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases
      in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a
      careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or
      amphetamine-positive urine drug screen during the study.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.; Inactive ingredient matching the active comparators in appearance.
Other intervention name(s): Abilify; Sugar Pill
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Use Disorder; Bipolar Disorder; Mood; Alcohol Craving; Aripiprazole; Schizoaffective Disorder
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical
      instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
    


Intervention name(s): EO9(Apaziquone)
Intervention type(s): Drug
Intervention description(s): immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
Intervention MeSH terms: Apaziquone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: bladder cancer; EO9; Apaziquone
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Condition: Test Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Randomized, blind parallel group design. Single intake of 55 g high Epicatechin /Melissa dark
      chocolate containing 160 mg Epicatechin per 55 g serving or single intake of 55 g low
      Epicatechin/ oat bran white chocolate containing < 0,00045 mg Epicatechin per 55 g serving.

      A Total of 128 participants, 64 in each group, approx. equal number of male and female. There
      will be replacement of Drop-Outs until data from 128 participants are completed.

      The primary endpoints will be performance in a pictorial memory task and a verbal memory task
      .

      The secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual
      analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.
    


Intervention name(s): High Epicatechin/ Melissa; Low Epicatechin/ Oat bran
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa; Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Increased Tidal Volume on Internal Jugular Vein Cross-sectional Area
Condition: General Anesthesia; Surgery
Study type: Interventional

Summary: 
      As increasing tidal volume, the cross sectional area and circumference of Internal Jugular
      Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase
      size of IJV. So investigators would compare the cross sectional area, circumference of IJV
      and peak airway pressure in neutral and Trendelenburg position
    


Intervention name(s): Tidal Volume
Intervention type(s): Other
Intervention description(s): observation of IJV circumference and cross sectional area using ultrasonography by changing of tidal volume
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: any operation that required for general anesthesia
Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19
Condition: COVID
Study type: Interventional

Summary: 
      As the world faces COVID-19, the search for effective treatments against the disease and its
      complications has turned its gaze to drugs that are classically used in other infectious
      diseases. Some drugs are being examined for the recent evidence on its effects on viral
      replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial
      infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase
      serum concentration of 25-hydroxyvitamin D.
    

Detailed description: 
      The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol
      combination in COVID-19 in early stages of the disease with outpatient management.

      Enrollment of subject into the trial shall only occur after providing written permission to
      voluntarily participate into the study by signing and dating the informed consent form before
      starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial
      with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19
      shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg
      once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient
      regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall
      be allocated as the control group for monitoring.

      Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient
      regimen.

      Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the
      trial.
    

Intervention name(s): Ivermectin; Azithromycin; Cholecalciferol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6mg once daily in day 0,1,7 and 8; 500mg once daily for 4 days; 400 IU twice daily for 30 days
Intervention MeSH terms: Cholecalciferol; Vitamin D; Azithromycin; Ivermectin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Relation 3:1 in Combination:Control groups
Masking: None (Open Label)
Primary purpose: Treatment
Tolerance Study of the Dietary Supplement Valedia
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this clinical study are to determine the tolerance of dietary supplement
      Valedia (blend of plant extracts) through the evaluation of several parameters :

        -  Various blood biological parameters for tolerance (preprandial): blood glucose, insulin,
           fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol,
           oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine,
           urea.

        -  Urinary parameters: urea, creatinine.

        -  Hemodynamic parameters: heart rate and blood pressure.

        -  Cardiac function: ECG.

        -  Weight.
    


Intervention name(s): Valedia
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of an insulin pump controlling
      algorithm while the subject is under close medical supervision in the Clinical Research
      Center (CRC) setting.
    

Detailed description: 
      This study is a non-randomized, uncontrolled feasibility study that looks to enroll people
      with type 1 diabetes who are currently using an insulin pump. During the subject's
      participation, the study staff will closely monitor the study subject in a clinical research
      center environment for approximately 24 hours, while controller algorithm determined insulin
      doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

      Total subject participation approximately 1 week for screening to completion. This includes
      approximately 24 hours usage of the investigation device in the clinical research center
      under close medical supervision.
    

Intervention name(s): Hypoglycemia-Hyperglycemia Minimizer System
Intervention type(s): Device
Intervention description(s): Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Type 1 Diabetes Mellitus; Artificial Pancreas
A Research Study to Examine Cutaneous Allodynia and Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Observational

Summary: 
      This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous
      allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli
      (e.g. light touch) are applied to the skin. Many studies have been performed looking at the
      presence of cutaneous allodynia in patients with migraines; however, few studies have
      examined it in cluster headache patients. There is still much to be learned about the brain
      and how it functions if the investigators are to understand the underlying causes of cluster
      headache. It is important to explore cutaneous allodynia in cluster headache as it may help
      guide physicians with the care of these individuals. Sixty patients will be screened for this
      study. Thomas Jefferson University is the only center enrolling patients in this research
      study.
    


Intervention name(s): There are no interventions in the observational study. The symptom of allodynia was measured.
Intervention type(s): Other
Intervention description(s): No intervention. Description of allodynia testing appears elsewhere in this document
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with cluster headache
A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate
      pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.
    

Detailed description: 
      This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in
      healthy male subjects.

      Study design is randomized, open-labeled, oral dose, crossover design. This study will
      conducted with 2 separated part (Part A, Part B).
    

Intervention name(s): DWC20151; DWC20152
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male
Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral
      tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived
      growth factor receptor, and fibroblast growth factor receptor, in patients with advanced
      hepatocellular carcinoma (HCC).
    

Detailed description: 
      As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the
      treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor
      tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2
      (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor
      receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid
      tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is
      also expected to be effective against HCC. However, because most HCC patients have
      accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of
      liver function impairment.
    

Intervention name(s): Orantinib (TSU-68)
Intervention type(s): Drug
Intervention description(s): 200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops
Intervention MeSH terms: Orantinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      This study is observational, non-controlled, multicentric and prospective, without
      experimental intervention or control. As part of the usual management of the subjects, scales
      will be used for the assessment of the spasticity and the quality of life (QoL).

      The purpose of this observational study is to assess the incidence of spasticity in a group
      of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it
      affects the QoL of these subjects.
    

Detailed description: 
      One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is
      defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an
      amplified reactivity of motor segments to sensory input. It is part of one of the components
      of the superior motoneurone syndrome and it may cause muscle rigidity and disability.

      The spasticity, which could be measured in electrophysiological, biomechanical and clinical
      terms, has a significant prevalence. It is a frequent cause for consultation among subjects
      with MS and, consequently, has a significant impact on the QoL. Men and those subjects with
      MS of longer duration are the most affected by spasticity.

      The aim of this study is to assess the impact that spasticity has on the QoL of subjects with
      MS.

      The total duration of the study is 24 months. The recruiting period will be 12 months. Once
      the recruiting time is over, the collection of data will continue during the full 24 months
      period that was planned.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with established diagnosis of RRSM for more than one year.
      
Keywords: Multiple Sclerosis, Relapsing Remitting; Quality of life
Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain
Condition: Neck Pain; Respiratory
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is
      useful for disorders associated with neck and arm pain. This study aimed to determine the
      effects of NM on respiratory function in patients with chronic neck pain.

      Methods: Overall, 26 patients with neck pain were randomly assigned to two groups: NM or
      control. In these participants, respiratory function and active cervical range of motion were
      assessed before and after intervention. Furthermore, the participants were provided a visual
      analog scale (VAS) and Fremantle Neck Awareness Questionnaire (FreNAQ). Each participant
      underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in
      addition to conventional treatment, 10 sessions of neural mobilization were performed.
    


Intervention name(s): Neural Mobilization
Intervention type(s): Other
Intervention description(s): Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment