bioihbjkbjnl/mcl2 huggingface dataset:
Human Composite Facial Allotransplantation
Condition: Transplantation: Facial Transplantation
MeSH terms: Facies
Study type: Interventional

Summary: 
      Allotransplantation of maxillofacial of subject with severe facial deformities due to
      traumatic events.
    

Detailed description: 
      A facial transplantation is a highly dynamic, prolonged operation requiring teams
      communicating seamlessly through its duration. This is similar to complex solid organ
      transplant teams at Methodist Transplant Institute. The Institute's clinical experience in
      management of complex facial defects and deformities along with the personnel and
      infrastructure at Methodist Dallas transplant institute would help develop a center for
      Facial Allotransplantation. The team experience, true collaboration, creativity and a unique
      approach to each patient would help provide the optimal care and reconstruction for the face
      allotransplant patient both before and after surgery.

      The purpose of this study is centered on the advancement of a safe and effective procedure
      for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite
      tissue allotransplantation for facial reconstruction is in its infancy as liver
      transplantation was 30 years ago when the first liver transplant was completed in Texas. This
      study will establish Methodist Hospital System as a center for Facial Allotransplantation for
      reconstruction of extensive facial defects resulting in functional loss and poor quality of
      life.

      Patient participation post transplantation will either be for life, or failure of the
      composite tissue allograft. Patient enrollment will be initiated immediately after the IRB
      approval. The enrollment period will be completed after the patient receives the final
      transplant, and the study will be completed at 24 months after the final transplant. However,
      all patients enrolled into the study will have lifelong follow up with immunosuppressive
      management, psychological support, and evaluation of functional recovery per protocol.
    

Intervention name(s): Facial Allotransplantation
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Facial Transplantation
Deep Phenotyping of Rosacea and Migraine
Condition: Migraine; Rosacea
MeSH terms: Migraine Disorders; Rosacea
Study type: Observational

Summary: 
      This study aims to deep phenotype patients with rosacea and migraine
    

Detailed description: 
      Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger
      factors, and distribution in the trigeminal area. Recent studies establish a connection
      between the two disorders, which needs to be investigated.

      The purpose of this study is investigate the link between the two disorders by deep
      phenotyping through semi-structured interviews.
    

Intervention name(s): No intervention apart from tests, including interview
Intervention type(s): Diagnostic Test
Intervention description(s): No interventions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Rosacea

          -  patients invited to participate through 3 different clinics in Copenhagen and Zealand,
             Denmark

        Migraine

          -  patients attending the outpatient clinic of the Danish Headache Center invited to
             participate
      
Biospecimen description: 
      Mouthswab for DNA-sampling
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
Condition: Virus Diseases; Hepatitis B
MeSH terms: Hepatitis B; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the immune response to Hepatitis B virus in children who have been primed with
      HEXAVAC or INFANRIX HEXA 10 years ago.
    


Intervention name(s): HBVAXPRO 5µg
Intervention type(s): Biological
Intervention description(s): 0.5mL intramuscular injection
Other intervention name(s): Hepatitis B vaccine (rDNA)
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the
      role of neuroactive steroids in individuals with alcohol use disorder (AUD).
    

Detailed description: 
      The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine
      reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in
      the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with
      AUD; and c) sex differences in all of these outcomes.
    

Intervention name(s): Pregnenolone300; Pregnenolone500; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300mg; 500mg; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind, placebo-controlled, parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Patients with atrial fibrillation are at increased risk of thrombus formation in the left
      heart, especially in the auricula and the atrium. Their presence increases the risk of
      ischemic stroke, especially during cardioversion, performed either by drug or by external
      electric shock. The gold standard to exclude this thrombus and consider cardioversion is the
      transesophageal echocardiography.

      D-dimers, products of the degradation of fibrin, have been studied several times to assess
      the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and
      despite several studies on the matter, there is currently no blood D-dimers value allowing to
      detect the presence of a thrombus with a good predictive value. Correlating the D-dimer
      values with age, as has been done for some years in pulmonary embolism, would give the
      opportunity to create a simple, inexpensive and widely applicable tool to eliminate the
      presence of a thrombus in the left heart.

      If the results are satisfactory, the investigators might consider not using transesophageal
      echocardiography as this examination is unpleasant for the patient and operator dependant,
      unlike a standard blood sampling.

      This study aims to test the following hypothesis: D-dimers values superior or equal to ten
      times the patient's age is predictive of a thrombus.
    


Intervention name(s): Blood sampling
Intervention type(s): Procedure
Intervention description(s): A blood sampling will be performed in patients diagnosed with atrial fibrillation in order to test if having a D-dimers value superior or equal to the patient's age is predictive of a thrombus.
Thombus will be diagnosed according to the standard of care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: D-dimers; Atrial fibrillation
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
Condition: Pediatric General Anesthesia With Endotracheal Tube
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ultrasound study of the airway to predict
      endotracheal tube size in anesthetized pediatric patients better than the tube size formula
    

Detailed description: 
      This study is to compare the methods of selecting uncuffed endotracheal tube size in
      pediatric patients between conventional age-based formula and ultrasound measurement of
      subglottic diameter.
    

Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Using ultrasound to determine the size of endotracheal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: ASA class 1,2; age 1-6 years; General anesthesia with ETT
Vitamin A Absorption From Cassava in Women
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the vitamin A equivalents in high-carotenoid
      varieties of cassava.
    

Detailed description: 
      We plan to conduct a single site intervention phase II intervention study in healthy adult
      women. Women will serve as their own controls, and will be fed three treatments in random
      order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of
      bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar
      meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the
      triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving
      ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using
      electrochemical detection. We plan to collect sufficient data to identify the times of the
      first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC),
      beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single
      meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to
      healthy adult women. We will use this data to determine the vitamin A equivalency of
      bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of
      bio-fortified cassava.
    

Intervention name(s): Beta-Carotene bio-fortified cassava porridge without oil; Beta-Carotene bio-fortified cassava porridge with oil; White cassava porridge with retinyl palmitate reference dose
Intervention type(s): Other; Other; Other
Intervention description(s): 300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.; 300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.; 300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.
Intervention MeSH terms: Beta Carotene; Vitamin A; Retinol palmitate; Carotenoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin A
A Study of Concurrent Chemoradiation With Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Condition: Extensive-stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed
      by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment
      for extensive-stage small cell lung cancer. When 4 cycles of EC/EP chemotherapy combined with
      PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

      In our study, the investigators bring radiotherapy forward, which means that after 2 cycles
      of EC/EP chemotherapy plus Atezolizumab, participants with response（PR/CR/SD）will receive
      concurrent radiotherapy and 2 cycles of EC/EP chemotherapy plus Atezolizumab, then
      maintenance therapy with Atezolizumab （Q3W）.

      The purpose of this study is to explore the safety and efficacy of Atezolizumab combined with
      concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung
      cancer.
    

Detailed description: 
      participants receive EC/EP chemotherapy combined with Atezolizumab for 2 cycles, and the
      efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent
      chemoradiotherapy comined with EC/EP(2 cycles) +Atezolizumab will be initiated. After
      concurrent chemoradiotherapy +Atezolizumab, Atezolizumab was maintained until PD or
      intolerance or for at most 2 years.

      participants with brain metastases will receive radiotherapy for brain metastases during the
      first 2 cycles of chemotherapy.
    

Intervention name(s): Radiation Therapy
Intervention type(s): Procedure
Intervention description(s): Thoracic Radiation Dose: 3Gy, QD, total dose: 30-45Gy; Particpants with brain metastases：metastatic lesions≤3:whole brain radiotherapy with local simultaneous PGTV:50Gy/10F；metastatic lesions>3:whole brain radiotherapy PTV:30Gy/10F.
Intervention model: Single Group Assignment
Intervention model description: To assess safety and tolerability of Atezolizumab Combined with Concurrent Chemoradiotherapy and maintenance therapy with Atezolizumab in untreated participants with extensive-disease small cell lung cancer.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extensive-stage small cell lung cancer; PD-L1; Atezolizumab; Concurrent Chemoradiotherapy
Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants
Condition: Amyotrophic Lateral Sclerosis (Healthy Volunteers)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center study conducted in 2 parts:

      Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled
      sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8
      participants (6 receiving SAR443820 and 2 placebo).

      Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for
      SAR443820 measurements in CSF and in plasma.

      Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized,
      placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4
      cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).
    

Detailed description: 
      The duration of the study for a participant will include:

      Screening Period: up to 28 days

      Part 1a:

      Treatment in fasted condition: 1 day (Day 1). Study observation Period from Day -2/Day -1 to
      Day 3. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening
      per participant: up to 5 weeks.

      Part 1b:

      Treatment in fed condition: 1 day (Day 1). Study observation Period from Day -1/Day1 to Day
      2. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per
      participant: up to 5 weeks.

      Part 2:

      Treatment: 14 days (Day 1 to Day 14). Study observation Period from Day -2/Day -1 to Day 17.
      Follow-up with the end of study: from Day 19 to Day 21. Total duration from screening per
      participant: up to 7 weeks.
    

Intervention name(s): SAR443820; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule / Oral; Matching Capsule / Oral
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1b with open label study design
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Evidence-based medicine suggests that acupuncture can improve major depressive disorder
      (MDD). However, the prevalent reliance on experiential acupoint selection lacks scientific
      underpinning. We conducted a comparative study involving MDD patients and healthy subjects,
      employing modern techniques to discern biological specificity in MDD-related acupoints.
      Additionally, we investigated potential correlations between acupoint biological specificity
      and MDD severity.
    

Detailed description: 
      A final total of 134 eligible subjects were included. Among them, 50 healthy subjects were
      assigned to the healthy control (HC) group and 84 MDD participants were assigned to the MDD
      group.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The diagnostic criteria of MDD were based on criteria proposed by the International
        Classification of Diseases 10th Edition (ICD-10). Healthy control participants were
        determined by a recent depression screening report for confirming their mental health
        conditions.
      
Keywords: Major Depressive Disorder; Acupoint; Biological specificity
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      It is important to consider the functional composite and quality of life of patients with
      multiple sclerosis (MS) and to plan interventions for these problems.
    

Detailed description: 
      The application of Self-Acupressure helps in improving the functional composite and quality
      of life in Multiple Sclerosis patients.
    

Intervention name(s): Self-Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Self-Acupressure; Functional composite; Quality of life
Drug Interaction Study Between Dorzagliatin and Empagliflozin
Condition: Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of
      glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics
      and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will
      be studied.
    


Intervention name(s): Empagliflozin; Dorzagliatin
Intervention type(s): Drug; Drug
Intervention description(s): Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration; Glucokinase activator currently under development
Other intervention name(s): Jardiance; HMS5552
Intervention MeSH terms: Empagliflozin
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed
      [Ambrosia artemisiifolia] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243
      (Timothy grass [Phleum pratense] extract, SCH 697243, GRASTEK®) sublingual tablets
      co-administered in participants 18 through 65 years of age with both ragweed- and grass
      polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma.
      The primary endpoint is the percentage of participants who experience at least one event of
      local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.
    

Detailed description: 
      Events of local swelling include pharyngeal edema, laryngeal edema, mouth edema,
      oropharyngeal swelling, palatal edema, tongue swelling/edema or throat tightness.
    

Intervention name(s): MK-3641 12 Amb a 1-U (short ragweed extract); MK-7243 2800 BAU (Timothy grass extract); Rescue Medication
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets; 2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets; Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.
Other intervention name(s): SCH 039641; RAGWITEK®; SCH 697243; GRASTEK®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of combined treatment with
      Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
    

Detailed description: 
      The successful treatment of melanoma with immune checkpoint inhibitors, such as
      anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1
      (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors.
      Despite these advances, only a portion of patients experience a durable response suggesting
      that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4
      (Ipilimumab) significantly improves overall survival and achieves long-lasting complete
      responses in some melanoma patients, the number of patients that achieve durable clinical
      benefit is limited and could be improved by a combined immunomodulatory approach. The
      objectives of this study are to assess the safety and efficacy of combined treatment with
      Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that
      combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor
      antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor
      cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.
    

Intervention name(s): VESANOID; Ipilimumab
Intervention type(s): Drug; Drug
Intervention description(s): All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).; Ipilimumab is current standard of care treatment for melanoma.
Other intervention name(s): ATRA; Tretinoin; IPI
Intervention MeSH terms: Ipilimumab; Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Malignant Melanoma