bioihbjkbjnl/mcl2 huggingface dataset:
Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
Condition: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neurotoxicity Syndromes
Study type: Observational

Summary: 
      RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve
      function may help doctors plan treatment and help patients live more comfortably.

      PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving
      chemotherapy or biological therapy for cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the change in peripheral nerve function in cancer patients during and after
           treatment with chemotherapy or biologic therapy.

        -  Determine the clinical measurement of hearing-related air and bone conduction and
           vibratory sensation in these patients.

        -  Correlate the changes in orthostatic blood pressure using both the Vasotrac automated
           blood pressure device and the standard clinical automated blood pressure equipment.

        -  Determine the patient's perception of hearing quality before and after treatment with
           chemotherapy or biologic therapy.

      OUTLINE: This is a multicenter study.

      Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory
      sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during
      treatment with chemotherapy or biologic therapy.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): management of therapy complications
Intervention type(s): Procedure
Intervention description(s): Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are receiving chemotherapy or biological therapy for cancer.
      
Keywords: neurotoxicity; unspecified adult solid tumor, protocol specific
PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL
Condition: Acute Lymphoblastic Leukemia; Pancreatitis
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Pancreatitis; Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      The purpose of this study is to create a model enabling us to predict pancreatitis,
      hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with
      Acute Lymphoblastic Leukemia.
    

Detailed description: 
      Leukemia is the leading cause of cancer in children in Europe and the U.S. with an annual
      incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years.

      Although the rate of cure has increased significantly, treatment is still unsuccesfull in
      appoximately 20 % of the patients. There is great variation in the how the individual patient
      processes the different chemotherapeutic agents. Furthermore there is a signifikant
      difference regarding the severity of sideeffects and toxicities. So far it has not been
      possible to predict which patients are at speciel risk of developing toxicities.

      Acute pancreatitis is a severe sideffect/toxicity when treating ALL. Patients are at risk of
      developing pancreatitis, because of the drug Asparaginase. The condition can not be prevented
      and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the
      drug, in spite of the fact that Asparaginase is on of the most important drugs when treating
      leukemia.

      In the current study we will map the occurence of pancreatitis, hepatotoxicity and
      hyperlipidemia among approximately 1000 children and adolescents with leukemia. This study is
      unique because it is the largest study of its kind regarding Asparaginase associated
      pancreatitis. Among other things it will involve extensive genetic analysis.

      We believe that this study will improve the possibilities, not only, for individualized
      treatmentVi mener at dette studie vil forbedre mulighederne for individ orienteret
      behandling, but also for other studies like this regarding other toxicities in patients with
      cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 1-17.9, diagnosed with ALL and undergoing treatment with Peg-Asparaginase.
      
Keywords: Acute Lymphoblastic Leukemia; Pediatric; Asparaginase; Pancreatitis
"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      Transbronchial lung biopsy (TBLB) is a bronchoscopic procedure used to obtain peripheral lung
      tissue. Small size and artefacts cause variable, and usually poor, diagnostic yield. The use
      of cryoprobes may allow for larger size and better quality biopsy samples.

      Objectives:To analyze the histological quality and immunohistochemical findings of samples
      obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the
      safety and complications of TBLB with cryoprobe versus the conventional method.

      Methodology:

      Prospective randomized study of 80 patients. The transbronchial lung biopsy was indicated for
      diagnoses of a interstitial lung disease. In both procedures the videobroncoscopy used will
      be a Olympus 260-T.

      The transbronchial lung biopsy will be carried out with conventional forceps (Boston ® Biopsy
      Forceps, Ref 1556 and Olympus ® FB-19E) and cryoprobe (Erbokryo AC ®). TBLB will be performed
      by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral
      lung previously selected according to CT findings. Lung biopsies will be processed: The
      samples submitted for histological analysis will be fixed in formalin and embedded in
      paraffin. Staining will perform with hematoxylin-eosin and Masson's trichrome and the samples
      will be analyzed by a pathologist according to a protocol. The samples submitted to
      immunohistochemical study will be frozen (liquid nitrogen) for later transport.The specifical
      monoclonal antibodies will be used for immunohistochemical analysis.
    


Intervention name(s): Biopsy by cryoprobes; Biopsy with conventional forceps
Intervention type(s): Procedure; Procedure
Intervention description(s): Transbronchial lung biopsy with cryoprobes.; Transbronchial lung biopsy with conventional forceps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Internet Treatment for Weight Loss in Primary Care
Condition: Overweight; Obese
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This study will test the effectiveness of two distinct treatments for weight loss:

        1. Motivational Interviewing

        2. Nutritional Counseling. These treatments will be compared to Treatment as Usual.
           Participants will be recruited through local primary care offices.
    


Intervention name(s): Motivational Interviewing; Nutritional Counseling; Treatment as usual with primary care physician
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 5 sessions of motivational interviewing over a period of 3 months.; 5 sessions of nutritional counseling over a period of 3 months.; Participants will be encouraged to continue their care with their primary care physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in
      patients. The current standard treatment for mild to moderate UC (MTMUC) includes
      5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients
      continue to experience disease symptoms and flare-ups. These patients require higher dosages
      of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy
      which comprises higher risk of hazardous side effects.

      Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively
      studied in the context of inflammatory diseases. In humans, a controlled study using curcumin
      as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in
      maintaining remission in MTMUC patients . A small, preliminary open label study has also
      shown efficacy in reducing disease symptoms and inflammatory markers in this group of
      patients .

      This data provides bases for investigating an integrative approach to optimize the current
      standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA
      medication and curcumin could benefit this subgroup of patients and reduce morbidity and
      perhaps need for escalating pharmacological intervention.
    


Intervention name(s): Curcumin; 5-aminosalicylic acid
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 3 capsules (820 mg containig 500 mg curcumin each) twice daily.; The dosage of 5ASA medication will be the maximum dosage given in this group of patients according to clinical guidelines (4gr' per os + topical 1gr mesalamine
Other intervention name(s): Pentasa, Asacol, Rafasal, Mesalamine.
Intervention MeSH terms: Aminosalicylic Acid; Curcumin; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis; Curcumin
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of this study is to implement and test the efficacy of the "Summer Harvest
      Adventure," a comprehensive garden-based behavioral, social, and environmental intervention
      for children (ages 8-11 years) residing in low-resource communities.
    

Detailed description: 
      The investigators will conduct a 2-arm randomized controlled trial designed to determine the
      efficacy of a multifaceted obesity prevention and lifestyle intervention in low-resource
      children and parent/adult caregiver (PAC) called "Summer Harvest Adventure." A total of 240
      children (ages 8-11 years) will be randomized to the garden-based intervention (SHA) or an
      enhanced control group (MSP). Summer Harvest Adventure includes: 1) remote and group coaching
      using a focused motivational interviewing approach; 2) weekly fruit, vegetable, and herb
      harvesting to increase summer food access; and 3) group education for children and their
      families in a social setting. Assessments for both groups will be collected at orientation
      held one week prior to the intervention (week 0), and immediately following the completion of
      the intervention (week 10) by trained personnel that are blinded to participants' treatment
      arm assignment.
    

Intervention name(s): Summer Harvest Adventure; My Summer Plate (MSP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Biobehavioral intervention focusing on nutrition and lifestyle behaviors.; My Summer Plate (MSP)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2 prospective randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity; youth; garden; diet; produce
A Study to Evaluate the Drug-drug Interaction Effect of Itraconazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of AMG 510
      administered alone and in combination with itraconazole in healthy participants.
    


Intervention name(s): AMG 510; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral capsule
Intervention MeSH terms: Itraconazole; Sotorasib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy participants; AMG 510; Itraconazole
Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      A proof of concept (POC) study evaluating the impact of BTRX-335140 (NMRA-335140) relative to
      placebo on symptoms of major depressive disorder (MDD) in adult participants with MDD and
      symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by
      the HAMD-17 Scale.
    


Intervention name(s): BTRX-335140; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NMRA-335140; Neumora; NMRA-140
Nabilone for Non-motor Symptoms in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label extension study for participants of the randomized placebo-controlled,
      double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study,
      assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients
      with Parkinson´s Disease (PD). Nabilone is an analogue of tetrahydrocannabinol (THC), the
      psychoactive component of cannabis. Nabilone acts as a partial agonist on both Cannabinoid 1
      (CB1) and Cannabinoid 2 (CB2) receptor in humans and therefore mimics the effect of THC but
      with more predictable side effects and less euphoria.

      Eligible patients will be re-tapered in an open-label nabilone dose optimization phase
      followed by an open-label period of 6 months on a stable nabilone dose.
    

Detailed description: 
      This is an open-label extension study for participants of the randomized placebo-controlled,
      double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study,
      assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients
      with Parkinson´s Disease. Nabilone is an analogue of tetrahydrocannabinol (THC), the
      psychoactive component of cannabis.

      Eligible subjects will be re-tapered with open-label nabilone, optimally up to the dose the
      patient had in the NMS-Nab Trial. It is the investigator´s decision to modify this dose, if
      necessary. The re-tapering will be performed up to a maximum dose of 1 mg twice daily.
      Treatment responders will enter the open-label treatment period for 6 months with visits
      being performed every 3 months in the context of the patient´s regularly scheduled visits in
      the specialized outpatient department. The last visit will be the Termination Visit.
      Following this, nabilone will be tapered. During this period the patients will receive phone
      calls every other day. A Safety Follow-Up Visit will be performed.
    

Intervention name(s): Nabilone 0.25 mg
Intervention type(s): Drug
Intervention description(s): capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
Other intervention name(s): Canemes
Intervention MeSH terms: Nabilone
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson´s Disease; cannabinoids; non-motor symptoms
DEFLECT I: Keystone Heart Embolic Deflection Trial
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      This is a research study using the Keystone Heart Embolic Deflection Device and involving
      patients with aortic stenosis (a disease of the aortic valve), to be treated with
      Transcatheter Aortic Valve Replacement (TAVR).

      The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve.
      The new valve is put into place using a long, thin tube called a catheter that is inserted
      into a small incision (cut) in the patient's groin and threaded through his/her arteries up
      to the heart.
    

Detailed description: 
      This is a research study using the Keystone Heart Embolic Deflection Device and involving
      patients with aortic stenosis (a disease of the aortic valve), to be treated with
      Transcatheter Aortic Valve Replacement (TAVR).

      The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve.
      The new valve is put into place using a long, thin tube called a catheter that is inserted
      into a small incision (cut) in the patient's groin and threaded through his/her arteries up
      to the heart.

      During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could
      break off from inside the arteries and travel to the brain. The embolism could be made of
      clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the
      embolism is carried through the blood to the brain, it could cause a stroke or other
      neurological (brain) problems. A stroke happens when blood flow to a part of the brain is
      blocked, causing brain cells to die.

      The Keystone Heart Embolic Deflection Device has been developed to prevent an embolism from
      going to the brain and causing a stroke or other brain damage. The device is a wire mesh
      filter that covers the vessels that carry blood to brain, deflecting any any blood clots or
      other materials away from the patient's brain and towards the lower body, where they are less
      likely to cause harm.
    

Intervention name(s): Keystone Heart Embolic Deflection Device
Intervention type(s): Device
Intervention description(s): The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TAVR
Motorized Movement Therapy & Pulmonary Functions in Down Syndrome
Condition: Pulmonary Functions; Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      To investigate the effects of the addition of motorized movement therapy versus conventional
      chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in
      children with Down Syndrome
    

Detailed description: 
      To investigate the effects of the addition of motorized movement therapy versus conventional
      chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in
      children with Down Syndrome (DS). Methods: This randomized controlled study included 40
      children (24 boys & 16 girls) with DS. Their ages ranged from 9 to 13 years. The control
      group received conventional chest physical therapy program, three sessions per week for 12
      weeks. The study group received an aerobic exercise regimen using a motorized movement
      therapy device 3 times /week in addition to the same traditional program used with the
      control group. Pulmonary function tests, and six-minutes walking test were measured at
      baseline, after 18 sessions and after 36 sessions of treatment.
    

Intervention name(s): motorized movement therapy
Intervention type(s): Other
Intervention description(s): The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases
Condition: Breast Cancer; Metastatic Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with
      temozolomide and to see how well it works in treating patients with breast cancer who have
      received previous treatment for brain metastases.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the objective response rate systemically and in the CNS to the combination
           of irinotecan hydrochloride and temozolomide among patients with breast cancer and
           progressive brain metastases that have progressed after previous treatment for brain
           metastases.

        -  To determine the toxicities associated with the combination of irinotecan hydrochloride
           and temozolomide in breast cancer patients with progressive brain metastases.

      Secondary

        -  To evaluate the time to first progression at any site (CNS or extra-CNS) in patients
           treated with the combination of irinotecan hydrochloride and temozolomide.

        -  To evaluate the overall survival of patients treated with the combination of irinotecan
           hydrochloride and temozolomide for brain metastases.

      OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7
      and 15-21. Treatment repeats every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study therapy, patients are followed every 4 weeks.
    

Intervention name(s): irinotecan hydrochloride; temozolomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irinotecan; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer; tumors metastatic to brain