bioihbjkbjnl/mcl2 huggingface dataset:
Therapy of Pragmatic Disorders in Brain-damaged Individuals
Condition: Brain Injuries, Traumatic; Right Hemispheric Stroke
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This study aims to assess speech therapy's effectiveness in understanding other people's
      thoughts (implied) using written stories. The main objective is to examine whether the
      therapy improves understanding of the stories worked on in the sessions. We also explore
      whether the observed progress is maintained one month after the end of treatment and whether
      it is generalized to neuropsychological tests, video material, and the participants' daily
      lives.

      This therapy will be administered to four individuals with brain lesions, for six weeks, at
      the rate of two weekly sessions of one hour.
    


Intervention name(s): Speech and language therapy
Intervention type(s): Behavioral
Intervention description(s): The intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement.
To help the participant in his understanding of the character's intention, he will be asked:
1) To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: "it's hot here" that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It
      remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A
      randomized double-blind study was conducted to determine whether prophylactic anticoagulation
      was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to
      prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were
      followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator
      also used logistic regression analysis with variable selection for obtaining the prediction
      model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical
      compression, duration of surgery). THA with short duration of surgery did not require
      prophylactic anticoagulation.
    


Intervention name(s): prophylactic anticoagulation
Intervention type(s): Other
Intervention description(s): prophylactic anticoagulation by rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Deep Vein Thrombosis; total hip arthroplasty; prophylactic anticoagulation; randomized study
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh
      IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be
      replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where
      the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement
      Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT - FER).

      Both are widely used methods of fertility treatment. However, to date no well designed
      studies have been reported in which the two methods have been compared. This study aims to
      compare the two treatments in order to establish the best treatment protocol.

      The study design is a single centre open randomized controlled trial funded by the Oxford
      Fertility Unit.

      100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible for
      the study will be recruited.

      After giving their written consent they will be randomised to one of 2 groups: Natural FER
      and HRT FER.

      Patients in both groups will be asked to attend one initial visit, which is additional to
      patients not taking part in the study.

      Subsequent visits will depend on the treatment group but will not be additional for study
      participants. All visits requiring ultrasound will involve recording 3-D measurements, which
      increases the length of each visit by approximately 10 minutes. A patient satisfaction
      questionnaire would be completed at the end of the cycle.

      A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit. If
      this is positive then further visits to the unit are arranged to confirm the clinical
      pregnancy.

      Inclusion in the study would not increase the length of time of either treatment cycle.
      Follow up would extend to obtaining pregnancy outcome information.
    


Intervention name(s): Nafarelin acetate, Oestradiol Valerate, Progesterone
Intervention type(s): Drug
Intervention description(s): Nafarelin acetate, Nasal spray, 400 mcg b.d., 4 weeks Oestradiol Valerate, tablet, 2mg o.d day 1-5, 2mg b.d. day 6-9, 2mg t.d.s day 10-13 (step-up protocol), 2mg q.d.s (if pregnancy confirmed, 4-10 weeks Progesterone, pessary, 200mg b.d. and t.d.s. (if pregnancy confirmed), 2-10 weeks
Other intervention name(s): Synarel,Progynova,Cyclogest
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Nafarelin; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; Frozen Embryo Replacement
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Condition: Hypokalemia
MeSH terms: Hypokalemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is designed to study the effect of the combination of licorice and
      hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy
      volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily
      hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day
      for 14 days given in the other arm. The study is a randomized, open-label cross-over trial.
      There is at least a 3-week wash-out between the arms. The hypothesis is that the combination
      of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the
      change in the plasma level of potassium between the arms.
    


Intervention name(s): Hydrochlorothiazide; Licorice
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Hydrochlorothiazide 25 mg a day for 14 days.; Licorice candy 32 grams a day for 14 days.
Other intervention name(s): Hydrex semi, ATC C03AA03; Pepe Original candy
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Condition: Hearing Loss; Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a pre-validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based
      in Stäfa (Switzerland).
    

Detailed description: 
      In this study one CE-labeled Phonak Behind-the-ear (BTE) devices is investigated including
      CE-labeled compatible accessories. The experimental device will be investigated regarding its
      performance of speech understanding in noise with and without an accessory existing of an
      external microphone to pick sound at a certain target. A secondary objective of this study is
      the investigation of the Overall system stability in daily life situations. The experimental
      device contains direct connectivity functionality. Another objective of this study is the
      investigation of the subjective occlusion effect of different acoustic couplings. This will
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based
      in Stäfa (Switzerland).
    

Intervention name(s): Phonak Bolero M90-M; Roger Select
Intervention type(s): Device; Device
Intervention description(s): The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss; The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli
Condition: Bioavailability
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study was to determine the absorption of isothiocyanates (ITC) after
      ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary
      biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of
      these ITC was studied comparing to the uncooked vegetable.
    

Detailed description: 
      Background Glucosinolates (sulphur-containing compounds) are hydrolyzed by the plant enzyme
      myrosinase to ITC, which have chemopreventive properties. No information has been reported
      about the metabolic fate of ITC in the kailan-hybrid broccoli, which physicochemical
      characteristics could greatly influence that metabolic fate. Previous studies have shown that
      cooking process of vegetables may vary the human absorption of the correspondent nutritional
      and bioactive compounds.

      Research Methods & Procedures A cross-over-design study of 7 subjects after ingestion of
      200-g raw or microwaved kailan-hybrid broccoli was conducted. Total ITC equivalents in the
      vegetable, urine and blood samples were determined by HPLC as the cyclocondensation product
      of 1,2-benzenedithiol.
    

Intervention name(s): raw broccoli
Intervention type(s): Other
Intervention description(s): To eat this plant material
Other intervention name(s): Bimi; Kailan hybrid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Broccoli; Isothiocyanates; Pharmacokinetics; Sulforaphane; Myrosinase
Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in
      different ways. Some block the ability of cancer cells to grow and spread. Others find cancer
      cells and help kill them or carry cancer-killing substances to them. Giving pentostatin
      together with cyclophosphamide and rituximab may kill more cancer cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin
      together with cyclophosphamide and rituximab works in treating patients with previously
      untreated chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the frequency of response in patients with previously untreated,
           intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with
           pentostatin, cyclophosphamide, and rituximab.

        -  To characterize the toxicity of this regimen in these patients.

      OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course
      1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV
      on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment
      repeats every 3 weeks for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed at least every 3 months for 1
      year.
    

Intervention name(s): rituximab; cyclophosphamide; pentostatin
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Rituximab; Pentostatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; stage I small lymphocytic lymphoma; stage II small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
Brief Intervention for Teen Pregnancy Prevention
Condition: Teen Pregnancy Prevention
Study type: Interventional

Summary: 
      Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine
      recommend that teen health providers screen for sexual risk behaviors and provide education
      and counseling to those at risk, there are currently no specific guidelines or protocols
      available to guide such practices, nor have there been any rigorous evaluations of efficacy.
      Preventing teen pregnancy through brief intervention in primary care holds the promise to
      have a significant public health impact and reduce health disparities by engaging, educating,
      and motivating the majority of teens who visit a primary care setting each year. In the
      current study, we seek to rigorously evaluate the impact of brief intervention vs.
      informational control on unprotected sexual intercourse among teens with past year
      unprotected sex at two primary care clinics serving predominately underserved, minority
      populations in New Mexico. The target population for the current study will be 1350 male and
      female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the
      Albuquerque Job Corps Wellness Center. Extensive formative work involving the study
      population will be conducted prior to the trial to refine the motivational interviewing-based
      brief intervention. Eligible youth will be randomly assigned to brief intervention or an
      informational control condition, in addition to regularly offered medically-based
      contraception consultation and prescription services. Follow-ups at 3- and 9- months will
      compare rates of unprotected sex and acceptance of long-acting reversible contraceptives.
      Brief education and counseling interventions could be feasibly implemented during the greater
      than eight preventive and acute primary care visits that the average US adolescent attends
      during their teen years. Such an approach could conserve valuable resources required by more
      intensive interventions for nonresponsive teens with greater need. Furthermore, social
      determinants of health, such as poverty and race, that may reduce access to more extensive
      psychosocial interventions, are less likely to prevent access to primary care, increasing
      health equity.
    


Intervention name(s): Teens Exploring and Managing Prevention Options (TEMPO)
Intervention type(s): Behavioral
Intervention MeSH terms: TEMPO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Screening and Brief Intervention; Motivational Interviewing; Teen Pregnancy Prevention
A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in
      subjects with active Psoriatic Arthritis (PsA).
    

Detailed description: 
      This is a Phase 2b, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Multiple Dose
      Study .

      Randomization to one of the treatments with NDI-034858 Dose 1, 2, 3 or placebo once daily
      (QD) will be based on a 1:1:1:1 scheme.

      The maximum study duration per subject is approximately 20 weeks, including up to 30 days for
      the screening period, a 12-week treatment period, and a 4-week safety follow-up period.

      Efficacy will be assessed using the ACR20 composite measure (including tender and swollen
      joint count, patient assessment of PsA pain visual analog scale (VAS), patient global PsA
      assessment VAS, physician global PsA assessment, HAQ-DI, and hsCRP) as well as the additional
      components. Efficacy for psoriasis among subjects who have ≥ 3% BSA) involvement on Day 1,
      will be measured using PASI, PGAs, and BSA.

      Safety will be assessed by collecting AEs, recording vital signs, performing physical
      examinations, and evaluating clinical laboratory and ECGs results.
    

Intervention name(s): NDI-034858; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Randomized participants will receive NDI-034858 capsule orally; Randomized participants will receive placebo orally
Other intervention name(s): TAK-279
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Placebo-Controlled; Double-blind; Multiple-dose study
Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
Condition: PreDiabetes; Obesity; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The study aims to investigate possible effects of per os Crocus Kozanis administration in
      children and adolescents with obesity
    


Intervention name(s): Crocus Kozanis; Placebo of Crocus Kozanis; Metformin
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.; Placebo of Crocus Kozanis; Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
Other intervention name(s): Saffron; Crocus Sativus; Saffron Kozanis; Metformin Hydrochloride
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in
      the management of patients with neck pain. However the mechanisms for pain relief associated
      with this intervention remain largely unexplained. Recent evidence suggests structures within
      the brain may have a role in creating responses of pain relief. This study aims to use
      functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow
      to structures within the brain following TSM in patients with neck pain. All patients will
      undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of
      the index finger and the great toe. Subjects will then receive either TSM or
      sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful
      stimuli. The primary outcome of interest is the shift in blood flow within the brain before
      and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD)
      technology. This study will be the first to examine this type of response to manual therapy
      within the brain in patients with neck pain.
    


Intervention name(s): Thoracic spine manipulation
Intervention type(s): Other
Intervention description(s): TSM thrust or non-thrust
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
PF-06741086 Long-term Treatment in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety, tolerability and efficacy of long-term
      treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month
      Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
    


Intervention name(s): PF-06741086
Intervention type(s): Biological
Intervention description(s): PF-06741086 subcutaneous injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemophilia