bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Legal Support Program on Women Experiencing Domestic Violence
Condition: Domestic Violence; Anxiety; Depression; Stress
MeSH terms: Depression
Study type: Interventional

Summary: 
      Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women
      have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers,
      advocates are first contact before the police. If the children are involved, finding the
      legal options become the priority for women before leaving the abuser.

      The purpose of this study was to compare the effectiveness of the HELP (Health, Education
      Legal Support Program) intervention among IPV survivors.
    


Intervention name(s): HELP
Intervention type(s): Other
Intervention description(s): Individual counseling were given to each intervention group participant. They were assisted with safety, emotional and mental support and referrals for health and financial assistance. Participants were also given handout to manage anxiety and panic situations during the legal procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Cellularity Yield of Three Different 22-gauge FNA Needles
Condition: Pancreatic or Peripancreatic Lesions; Lesions in the Esophagus, Stomach, Duodenum or Rectum; Mediastinal ( Chest) Masses; Enlarged Lymph Nodes
MeSH terms: Lymphadenopathy
Study type: Interventional

Summary: 
      Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a
      flexible tube with a camera and small ultrasound machine at its end )requires the use of a
      needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)".
      Currently, FNA is done by three commercially available needles. These needles are used
      routinely in our institution for FNA. The data regarding the safety and the successfulness of
      any of these needles are lacking. We sought to compare all three commercially available
      needles in a prospective manner.
    

Detailed description: 
      The following are being done only for research purposes; prior to performing the FNA, The
      patient will be randomized to one of the three commercially available FNA needles. At this
      time, all needles are considered equivalent and there is no medical necessity to pick one
      over another. The sample obtained by the needle will be assigned a quality score based on
      certain parameters of the sample such as the abundance of diagnostic cells and the presence
      of blood. We are going to collect certain information about your procedure such as the
      complications of the procedure, number of needle passes and final diagnosis.
    

Intervention name(s): Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Pancreatic adenocarcinoma; lymphadenopathy; Endoscopic ultrasound
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER
Condition: GnRH Trigger and Rescue Protocol
Study type: Observational

Summary: 
      Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of
      Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH
      antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk
      of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing
      Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To
      reduce this occurrence several studies have focused on the importance of support of the
      luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of
      OHSS (<18 recovered oocytes) which performed GnRH trigger and rescue protocol.
    


Intervention name(s): GnRH agonist
Intervention type(s): Drug
Intervention description(s): In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).
Other intervention name(s): GnRH trigger
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In HR patients (AMH> 3.5 ng / ml, AFC> 15 follicles and if more than 18 follicles with
        diam. 12mm to induction) the trigger was obtained with triptorelin 0.2 mg / sc. In patients
        considered to be at intermediate risk of OHSS a rescue protocol has been implemented (HCG
        1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily)
        and fresh embryo transfer.
Impact of Periodontal Treatment on Local miRNA Expression
Condition: Cardiovascular Diseases; Periodontal Diseases
MeSH terms: Periodontal Diseases; Cardiovascular Diseases
Study type: Observational

Summary: 
      To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root
      planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p,
      miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with
      periodontitis extent.
    

Detailed description: 
      The patients selected for the study were divided into 2 groups: group 1 (FM-SRP), group 2
      (Q-SRP). Any selected subject underwent anamnestic and periodontal examination, blood and GCF
      sampling. MiRNA in the GCF was extracted through a commercially available kit and then
      measured carrying out real-time quantitative polymerase chain reaction (RT-PCR).
    

Intervention name(s): changes of gingival crevicular fluid miRNA
Intervention type(s): Other
Intervention description(s): Evaluation of changes of gingival crevicular fluid miRNA after periodontal treatment
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Q-SRP (no. 44 patients), FM-SRP (no. 45 patients)
      
Keywords: Periodontitis, GCF
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Condition: Vaginal Infection; Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Observational [Patient Registry]

Summary: 
      The low Histatine-5 (HST-5) level of the saliva can lead to vaginal candidiasis. Because
      HST-5 level in the saliva can effect vaginal Ph, flora and local defence mechanisms.

      Histatine-5 is secreted in the parotis and submandibular glands. İt riches histidine amino
      ascid and have antifungal activity. Salivary proteins and their plasma levels were found as
      similar in the literature.
    

Detailed description: 
      Women with regularly menstrual cycle will enroll in the study than will separate two groups:

      Study group: women with vaginal candidiasis ( diagnosed by clinic and lab.)

      Control group: women ( not have any vaginal infections candida and others)

      Saliva samples will be taken from two groups than HST-5 level will be analyzed. Finally HST-5
      levels of the two groups will be compared .

      Women with diabetes, immun deficiency, pregnancy, virgin, menopausal period , premature
      ovarian failure will be excluded.
    

Intervention name(s): salivary sample
Intervention type(s): Other
Intervention description(s): salivary sample
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal
        infection.
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells.
      Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any
      remaining tumor cells.

      PURPOSE: Phase II trial to determine the effectiveness of surgery with or without
      radiofrequency ablation followed by irinotecan in treating patients who have colorectal
      cancer that is metastatic to the liver.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the disease-free survival in patients with hepatic metastases from primary
           colorectal carcinoma treated with surgical resection with or without radiofrequency
           ablation followed by irinotecan.

        -  Determine the overall survival in patients treated with this regimen.

        -  Determine the treatment-related toxicity of this regimen in these patients.

        -  Correlate the measurement of molecular markers with clinical outcome in patients treated
           with this regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to treatment with
      radiofrequency ablation in addition to resection (yes vs no).

      Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8
      weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy
      repeats every 3 weeks for a total of 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
    

Intervention name(s): irinotecan hydrochloride; adjuvant therapy; conventional surgery; radiofrequency ablation
Intervention type(s): Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Irinotecan
Primary purpose: Treatment
Keywords: liver metastases; stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; recurrent rectal cancer
Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
Condition: Premenstrual Syndrome; Stress
MeSH terms: Premenstrual Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual
      symptom (PMS) symptoms, perceived stress level and pain intensity.
    

Detailed description: 
      The research is a quantitative study, and it is in the form of randomized controlled type
      research, one of the experimental research types. The sample of the study consisted of people
      who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and
      volunteered to participate in the study. Participants will be divided into 2 groups as
      experimental group and control group by randomization method. Sociodemographic Information
      Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack
      Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data
      were statistically analyzed and compared.
    

Intervention name(s): Pilates Based Exercises; control
Intervention type(s): Other; Other
Intervention description(s): The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises.
Exercise Program:
Arm Circles
Toe Touch
bridge
Shoulder Bridge
Chest Lift
Hundred
Roll Up
Leg Circles
Chris Cross
Side Kick
Side Leg Circles
one leg kick
double leg kick
Swan
Single leg Stretch
Double leg Stretch
saw
Spine Stretch; They will be asked not to participate in any regular exercise for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilates exercises will be given to the experimental group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress; Pilates Based Exercises
The Effect of Distant Reiki on Pain and Holistic Well-being
Condition: Phantom Limb Pain
MeSH terms: Phantom Limb
Study type: Interventional

Summary: 
      Phantom limb pain is a condition characterized by painful sensations in the missing part of
      the amputated limb, which reduces the quality of life of the individual. It has been reported
      that approximately 85% of patients undergoing amputation experience phantom limb pain, and
      chronic pain is the most common symptom in individuals who have undergone limb amputation.
      These problems negatively affect individuals physically, mentally and socially and lead to
      deterioration of holistic well-being. This study will be examined the effect of distant reiki
      on pain and holistic well-being of ındividuals with phantom pain after amputation.
    

Detailed description: 
      Phantom limb pain is a condition characterized by painful sensations in the missing part of
      the amputated limb, which reduces the quality of life of the individual. It has been reported
      that approximately 85% of patients undergoing amputation experience phantom limb pain, and
      chronic pain is the most common symptom in individuals who have undergone limb amputation.
      These problems negatively affect individuals physically, mentally and socially and lead to
      deterioration of holistic well-being.

      Reiki is one of the holistic health practices that is effective in maintaining the balance
      between body, mind and spirit, which forms the basis of holistic well-being. Reiki, known as
      an energy-based therapy, helps to rebalance the natural energy flow circulating in the body
      and to increase the body's self-healing ability, and it prevents or repairs physical,
      emotional and mental imbalances by regaining the energy we lost in daily life. The purpose of
      Reiki practice is to promote health and well-being by helping to relax and reduce
      stress.There is no study in the literature examining the effect of reiki application on
      phantom pain and holistic well-being.This study was planned to examine the effect of remote
      reiki applied to individuals with post-amputation phantom pain on pain and holistic
      well-being.It is thought that it will contribute to the literature in terms of being the
      first research to be done on this subject.
    

Intervention name(s): Distant reiki group
Intervention type(s): Other
Intervention description(s): According to Classical Usui Reiki, Reiki II. Remote Reiki will be practiced every day for 10 days by researchers who have completed the Phase 1 training. The time of remote reiki application will be planned by talking with the patient.
Intervention model: Single Group Assignment
Intervention model description: This study is an experimental one-group pre-test-post-test design.
Masking: None (Open Label)
Primary purpose: Supportive Care
Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the absolute bioavailability of CORT118335 and determine the mass
      balance recovery, absorption, metabolism and elimination, and metabolite profile and
      identification of metabolite structures following a single oral dose of CORT118335 in healthy
      male participants.
    


Intervention name(s): CORT118335 Oral; 14C-CORT118335 intravenous; 14C-CORT118335 oral
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration; 14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C; 14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C
Other intervention name(s): Treatment A; Treatment B; Treatment C
Intervention MeSH terms: Cortisone
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia®
Condition: Healthy Allogeneic Donors; Granulocyte Colony-stimulating Factor (G-CSF) Mobilized
Study type: Interventional

Summary: 
      The study will determine the advantage of the Spectra Optia® IDL set compared to the standard
      collection set for collection of peripheral blood progenitor cells using the Spectra Optia®
      apheresis system. The study will assess the reduction of apheresis time to obtain the
      required amount of hematopoietic progenitor cells.
    

Detailed description: 
      Peripheral blood progenitor cells (PBPC) collected by apheresis are the most common stem cell
      source for allogeneic hematopoietic stem cell transplantation.

      Recently, Terumo BCT introduced a novel automated apheresis system for PBPC collection. The
      Spectra Optia® apheresis system uses the Spectra Optia® Collection set and the MNC software
      for PBPC collection. This system combines continuous centrifugation (high g) and subsequent
      cellular collection into an elutriation chamber, where the platelets are elutriated from
      mononuclear cells. An optical sensor detects when red blood cells begin to be elutriated and
      subsequently triggers the collection of the buffy coat into the product bag by flushing the
      chamber with donor plasma. Thus PBPCs are harvested intermittently. In contrast, the same
      apheresis systems in combination with the Spectra Optia® IDL set and the WBC-D software,
      which has been designed to perform leukodepletion procedures, permits continuous PBPC
      centrifugation (low g) and harvesting.

      The investigators hypothesis is that the use of the IDL set with manual adaption of the
      WBC-D-software allows a more efficient PBPC collection compared to the collection set which
      is recommended for PBPC collection. The apheresis time to collect the same amount of target
      cells dependent on the donors peripheral blood count will be shortened. In addition, the
      investigators want to compare both systems with respect to the cellular composition of the
      apheresis product and the donors platelet loss and coagulation parameters during apheresis.
    

Intervention name(s): Spectra Optia® IDL-Set; Spectra Optia® Collection Set
Intervention type(s): Device; Device
Intervention description(s): Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator; Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: apheresis; peripheral blood progenitor cells; peripheral blood stem cells
Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose
      and multiple ascending dose study. The study is designed to assess the safety, tolerability,
      PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy
      subjects.
    


Intervention name(s): CKD-508 Capsule; Placebo Capsule; CKD-508 Tablet; Placebo Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational drug; Placebo; Investigational drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected NCSLC
Condition: Adjuvant; Chemotherapy; Lung; Cancers
Study type: Observational

Summary: 
      There are limited numbers of retrospective studies showing the effectiveness of adjuvant
      chemotherapy over observation in resected lung cancers.
    

Detailed description: 
      We propose to retrospectively examine the Washington University School of Medicine experience
      on all patients receiving adjuvant chemotherapy between 2003 and 2005. We will
      retrospectively analyze the survival and outcomes in the lung cancer patients receiving
      adjuvant chemotherapy following surgical resection.
    

Observational model: Case-Only
Time perspective: Retrospective
Keywords: adjuvant; chemotherapy; observation; resected; cancers
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
Condition: Medulloblastoma
MeSH terms: Medulloblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a combination of a radiochemotherapy
      (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in
      adult patients with medulloblastoma is tolerable.
    

Detailed description: 
      As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are
      often treated in the scope of expanded access treatments or within pediatric studies;
      although, it is not known whether medulloblastomas act in the same way in adulthood and in
      childhood. This is the first study to investigate the significance of a combination of a
      radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin,
      cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a
      starting point for the development of chemotherapeutical protocols in adults.
    

Intervention name(s): maintenance chemotherapy (vincristin, cisplatin and CCNU); Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): maintenance chemotherapy of maximum of 8 cycles á 42 days; Radiotherapy of the partial brain
Other intervention name(s): Vincristin: L01CA02; CCNU: Lomustin L01AD02; cis-platin: L01XA01
Intervention MeSH terms: Cisplatin; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medulloblastoma; CNS; malignant neoplasm; NOA; neuroectodermal tumor; Vincristin; CCNU; Cisplatin