bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
Condition: Photodamaged Skin; Wrinkles
Intervention: Retinol; Tretinoin
Intervention description: 1.0% cream; 0.02% cream
Intervention MeSH terms: Vitamin A; Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Retinol; Tretinoin

Summary:

      The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin
      0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe
      photodamage. Our hypothesis is that both products will be of comparable benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 35 or over

          -  Moderate to severe photodamage

        Exclusion Criteria:

          -  History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or
             facial fillers

          -  History of keloids or hypertrophic scars

          -  Use of oral steroids or oral retinoids (such as Accutane) in past 6 months
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
Condition: Squamous Cell Carcinoma of Anal Canal
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Retifanlimab
Intervention description: Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous carcinoma of the anal canal; anti-PD-1 antibody; IgG4 monoclonal antibody; INCMGA00012

Summary:

      The purpose of this study is to assess the efficacy of INCMGA00012 in participants with
      locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have
      progressed after platinum-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to comprehend and willingness to sign a written informed consent form.

          -  Confirmed diagnosis of locally advanced or metastatic SCAC.

          -  Must have received (or been intolerant to or ineligible for) at least 1 prior line of
             platinum-based chemotherapy and received no more than 2 prior systemic treatments.

          -  Must have measurable disease by RECIST v1.1.

          -  Eastern Cooperative Oncology Group performance status of 0 to 1.

          -  If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥
             300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

        Exclusion Criteria:

          -  Receipt of anticancer therapy or participation in another interventional clinical
             study within 21 days before the first administration of study drug; 6 weeks for
             mitomycin C.

          -  Radiotherapy within 14 days of first dose of study treatment with the following
             caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy
             that is > 30 Gy.

          -  Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death
             ligand protein 1 (PD-L1)-directed therapy.

          -  Active autoimmune disease requiring systemic immunosuppression.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

          -  Known active hepatitis infection.

          -  Active infections requiring systemic therapy.

          -  Is pregnant or breastfeeding or is expecting to conceive or father children within the
             projected duration of the study, from screening through 6 months after the last dose
             of study drug.
Sphenopalatine Ganglion Block for Headache After Concussion
Condition: Concussion; Headache
MeSH terms: Ganglion Cysts; Headache
Intervention: Lidocaine in SphenoCath device; Saline Solution in SphenoCath device
Intervention description: Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.; Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Concussions; headaches; sphenopalatine ganglion block

Summary:

      This clinical trial will enroll participants to evaluate the effects of SPG block on
      post-traumatic headache. The study hypothesizes that patients that receive a SPG block with
      lidocaine vs. placebo (saline) will have a lower number of headache days in the week
      following the procedure, and will also report lower symptom scores.

      Eligible participants will receive one treatment (SPG block) as well as complete surveys
      prior to and after receiving treatment (for a total of approximately 2 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a concussion and are greater than 14 days from the date of their
             injury.

          -  Experiencing greater or equal than 4 occurrences of headache per week lasting at least
             1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.

        Exclusion Criteria:

          -  Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)

          -  Frequent epistaxis (i.e. more than one nose bleed per month),

          -  Bleeding disorders

          -  History of any of the following: nasal or facial fracture, nasal septal defect, any
             other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome,
             Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or
             intraventricular heart block

          -  Pregnant

          -  Are at increased risk for methemoglobinemia (including patients with
             glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic
             methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to
             oxidizing agents or their metabolites and drugs associated with methemoglobinemia)
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Condition: Neuropathic Pain Due to Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Intervention: V158866; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Neuropathic pain; Spinal cord injury

Summary:

      The purpose of this study is to investigate whether V158866 is safe and effective for the
      treatment of neuropathic pain due to spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 18 - 65 years

          -  documented spinal cord injury at or below T5

          -  moderate pain at or below the level of the spinal cord injury for at least 3 months

          -  compliant with daily diary

          -  stable pain scores on the NRS

          -  mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS
             score is >9, the mean Gracely score must be ≤19)

        Exclusion Criteria:

          -  women of child-bearing potential

          -  men who intend to father a child

          -  a history of multiple drug allergies, hypersensitivity to any cannabinoid

          -  an increased risk of seizure

          -  evidence of depression and/or a score of >19 on the BDI-II

          -  suicidal ideation or suicidal behavior in the past 10 years

          -  a history of substance abuse or dependence within the past year, excluding nicotine
             and caffeine

          -  a positive urine test for cannabis at screening

          -  taking excluded medications that cannot be stopped

          -  a positive pregnancy test
Long Term Use of the Provox Vega 22.5
Condition: Total Laryngectomy
Intervention: Provox Vega voice prosthesis 22.5 Fr
Intervention description: The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Healthy volunteers: No
Keywords: laryngectomy; Provox Vega; voice prosthesis

Summary:

      The purpose of this study was to investigate the long-term feasibility of the new Provox Vega
      22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system
      (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  total laryngectomy

          -  Provox2 user

          -  at least two previous replacements

        Exclusion Criteria:

          -  patients' refusal

          -  fistula problems

          -  Provox ActiValve users
High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
Condition: Solid Tumors; Brain Tumors
MeSH terms: Neoplasms; Brain Neoplasms
Intervention: Amifostine
Intervention description: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.
Intervention MeSH terms: Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Solid Tumors; Brain Tumors

Summary:

      This is a study of amifostine to determine how effective it is in the reduction of infection
      in a high dose chemotherapy regimen with autologous stem cell rescue in children with high
      risk, relapsed or refractory pediatric solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's
             tumor, peripheral PNET

          -  High risk desmoplastic small round cell tumors (DSRCT)

          -  Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor

          -  High risk brain tumors including PNET/Medulloblastomas/germinomas

          -  Relapsed germ cell tumors

          -  Metastatic or relapsed rhabdoid tumors

          -  Other relapsed/refractory pediatric embryonal tumors

          -  Less than 30 years of age

          -  Performance >= 50%

          -  Cancer Diagnosis verification and staging

          -  Disease Response and Recovery

          -  Adequate Organ Function (Renal, Liver, Cardiac)

        Exclusion Criteria:

          -  Uncontrolled Infection

          -  Pregnancy or Breastfeeding (For Females)

          -  Disease Progression

          -  Uncontrolled Intercurrent Illness

          -  HIV Positive

          -  Receiving other Investigational Agents

          -  Amifostine Allergy
To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: GBR 830; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic
      dermatitis to enable further studies in this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years or older

          -  Atopic dermatitis involvement that of at least 10% body surface area

        Exclusion Criteria:

          -  Treatment with systemic corticosteroids within 4 weeks before randomization, and
             topical steroids, tacrolimus and/or pimecrolimus within 1 week before the
             randomization (except emollients, and mild steroids (class 6 or 7)

          -  Any cell-depleting agents including but not limited to rituximab: within 6 months
             prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to
             normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to
             the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before
             the baseline visit.

          -  Patient with history of serious local infection and systemic infection Patient with
             history or current evidence of diseases such as tuberculosis, malignant disease, other
             inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.
BOTOX® for the Treatment of Platysma Prominence
Condition: Platysma Prominence
Intervention: BOTOX® purified neurotoxin complex; Placebo
Intervention description: BOTOX® superficial intramuscular injections.; Placebo injections.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma
      prominence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants willing to minimize the risk of inducing pregnancy for the
             duration of the clinical study and follow-up period

          -  A female participant is eligible to participate if she is not pregnant (has a negative
             urine pregnancy result prior to randomization), not breastfeeding, and at least one of
             the following conditions applies:

               1. Not a woman of childbearing potential (WOCBP) OR

               2. A WOCBP who agrees to follow the studies contraceptive guidance during the
                  treatment and follow-up period through study exit.

          -  Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             study's protocol

        Exclusion Criteria:

          -  Any medical condition that may put the participant at increased medical risk with
             exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,
             amyotrophic lateral sclerosis, or any other condition that might interfere with
             neuromuscular function

          -  Participant has an anticipated need for treatment with botulinum toxin of any serotype
             for any indication during the study (other than study intervention)

          -  Anticipated need for surgery or overnight hospitalization during the study

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study

          -  Females who are pregnant, nursing, or planning a pregnancy during the study

          -  Known immunization or hypersensitivity to any botulinum toxin serotype

          -  History of alcohol or drug abuse within 12 months of the study

          -  Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure
             the neck
Comparison Study of PTHrP and PTH to Treat Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Parathyroid hormone related protein (1-36); Parathyroid hormone related protein(1-36); Parathyroid hormone (1-34)
Intervention description: PTHrP (1-36) 400 micrograms / day administered subcutaneously for 3 months; PTHrP(1-36)600 micrograms subcutaneously administered daily for 3 months; PTH(1-34)20 micrograms subcutaneously administered daily for 3 months
Intervention MeSH terms: Teriparatide; Hormones; Parathyroid Hormone; Parathyroid Hormone-Related Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 105.0
Sex: Female
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: osteoporosis; post-menopausal; bone anabolic agents

Summary:

      This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and
      two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators
      want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal
      women with osteoporosis stimulates bone formation to the same or greater degree than PTH
      (1-34) but with less bone resorption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  45 - 75 year old Caucasian, Hispanic or Asian women

          -  one year post-menopausal if older than 50 years

          -  three years post-menopausal if between the ages of 45 - 50 years

          -  body mass index less than or equal to 30

          -  T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of
             lumbar spine or hip

          -  have at lease two spinal vertebrae evaluable by DXA analysis

        Exclusion Criteria:

          -  bisphosphonate therapy within the last two years

          -  estrogen replacement hormones or SERMS within last one year

          -  no more than one week of PTHrP, PTH, or an analog of PTH within the last year

          -  an atraumatic bone fracture within the last 6 months

          -  significant or active diseases of any organ system

          -  history of malignancy

          -  anemia with a hematocrit less than 34%

          -  significant drug or alcohol abuse

          -  having received any investigational drug within the last 90 days

          -  taking any medication that may interfere with skeletal metabolism, such as
             phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide

          -  abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin
             D less than 20 ng/ml or PTH greater than 65 pg/ml

          -  African-Americans for this particular study - although future studies are planned
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Intervention: Vi-CRM197 vaccine; Vi Polysaccharide (PS) vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 200.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the
      Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is
      highly endemic and an efficacious vaccine against this disease is very much needed.
    

Eligibility criteria:

        Main eligibility criteria:

          -  Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45
             years of age), children (24 to 59 months of age), older infants (9 to 12 months of age
             at enrollment) and infants (6 weeks of age at enrolment).

          -  Written informed consent will be obtained by the all subjects or their parents/
             guardians (depending on the age group) before enrollment into the trial.

          -  Only females with a negative pregnancy test and willing to participate in family
             planning consultations (organized by the site study team) will be allowed to
             participate to the trial.

          -  Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be
             enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6
             weeks of age as per local EPI schedule cannot be enrolled into the trial.
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Condition: Common Cold Associated With Cough
MeSH terms: Common Cold; Cough
Intervention: N-acetylcysteine; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: N-acetylcysteine; adults; cough and cold

Summary:

      This study is designed to improve knowledge regarding the initial effectiveness of
      N-acetylcysteine (NAC) on cold and cough symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cold/URTI symptoms occurring no more than 4 days

          -  cough due to a cold or acute viral (URTI) with an onset of no more than 3 days

          -  cough frequency with specified cut-off

        Exclusion Criteria:

          -  A subchronic, or chronic cough (cough duration > 2 months) due to any condition other
             than a cold/URTI

          -  Diagnosed as suffering from any pulmonary conditions associated with cough, e.g.,
             chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma,
             cystic fibrosis

          -  Taking any medications known to induce cough

          -  Fever of greater than 39°C (102°F) orally

          -  Complication of the common cold like otitis media, severe sinusitis, or pneumonia

          -  Other protocol-defined inclusion/exclusion criteria may apply