cyrilzakka/clinical-trials huggingface dataset:
Oral Iron for Erythropoietic Protoporphyrias

In the medical literature there are conflicting reports on whether iron improves symptoms in patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of this study is to determine the effect of oral iron for EPP and XLP patients.

This is a clinical trial, which means its purpose is to study an intervention or treatment. In this study all patients with EPP or XLP will be given a standard dose of iron pills and monitored for one year. There is currently no effective Food and Drug Administration (FDA) approved treatment for EPP or XLP in the US. Giving iron to patients with low ferritin (a measure of body iron stores) levels may help improve their EPP symptoms by decreasing erythrocyte protoporphyrin levels.

Patients will be asked come to the study site once every three months over the course of a year for a total of five visits. At these visits the study doctors will check in with participants and some blood and urine samples will be taken. Participants will not be charged for any of the lab tests that are being done for part of this study alone. In between these study visits there will be phone call to check in and see how participants are doing. All patients in this study will receive iron pills at no cost to them.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Longitudinal Study of the Porphyrias
* Male or female age ≥18 years
* History of nonblistering cutaneous photosensitivity
* Biochemical findings - A marked increase in erythrocyte protoporphyrin (total erythrocyte protoporphyrin \>400 ug/dL) with a predominance of metal-free protoporphyrin
* Serum ferritin ≤30 ng/mL at baseline
* Able to tolerate oral iron

Exclusion Criteria:

* History of liver or bone marrow transplant or clinically significant liver dysfunction as determined by the investigator
* Known or suspected allergy to oral iron based on patient report
* Clinical evidence of active and ongoing GI bleeding
* Use of any other clinical or experimental therapy in the past 3 months
* Individuals with elevations of porphyrins in plasma or erythrocytes due to other diseases (i.e. secondary porphyrinemia) such as liver and bone marrow diseases
* Patients with any clinically significant comorbid conditions, which in the opinion of the investigator, precludes participation
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient is blood group O+
* Anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion
* Expected to require no more than 2 units of Fresh Whole Blood in the 3 days following randomization
* Agree to return to the hospital for the follow-up visits
* Women of Child Bearing Potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation.
* Patient or legally authorized representative has given written informed consent

Exclusion Criteria:

* Symptoms of clinical malaria (confirmed by microscopy)
* Patient has received antimalarial treatment within 7 days prior to randomization
* Fever (Central body temperature greater than 38.5°C)
* Massive bleeding expected to require more than two Fresh Whole Blood units within 3 days from randomization
* Transfusion(s) of a blood product within 1 month prior to randomization
* Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment
* Previous treatment with other pathogen-reduced blood products
* Females who are pregnant
A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

Primary Objective:

To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies.

Secondary Objectives:

To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in patients with MS.

The total study duration for a patient is approximately 47 months.

There is no administration of GZ402668 in the LTS14120 study. Patients who already received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 will be followed up to 47 months in the LTS14120.

Note: Patients from TDU14981 study (sanofi-sponsored) will participate in LTS14120 study. In order to keep consistent among all study related documents, the title of the LTS14120 study is not amended.

Eligibility Criteria:
Inclusion criteria:

Received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
* Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable \*\* or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
* Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
* It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
* Presence of measurable disease according to RECIST 1.1 criteria;
* ECOG performance status of 0-1;
* ≥ 18 years;
* Adequate marrow reserve indicated by:

  * Absolute neutrophil count (ANC) ≥ 1500 / mm³ or Platelets\> 100,000 / mm³
  * Hemoglobin ≥ 9 g / dL - red blood cell transfusion will be allowed in the screening period if necessary
* Adequate renal and hepatic function:

  * Serum bilirubin ≤ 1.5 times the upper limit of normal the TGO and TGP ≤ 3 upper limit of normal. If hepatic metastasis ≤ 5 upper limit of normal
  * Serum creatinine ≤ 1.5 mg / dL and creatinine clearance ≥ 60 mL / min calculated by Cockcroft-Gault.

Exclusion Criteria:

* Patient submitted to curative resection of the primary site and / or metastatic site. NOTE: Patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible;
* Radiation therapy or previous chemotherapy for head / neck tumor;
* Patients with occult primary tumor;
* T4 from any site, resectable, with invasion of cartilage or jaw;
* History of BMT or stem cell therapy;
* Synchronous tumor or previous history of neoplasia, except for in situ carcinoma of the cervix, basal cell carcinoma or epidermoid carcinoma. Patients with previous history of cancer already treated and without evidence of disease for more than 3 years may participate in the study;
* Prophylactic use of G-CSF or GM-CSF two weeks prior to the study;
* Clinically significant heart disease: unstable angina or myocardial infarction 6 months prior to study entry Symptomatic ventricular arrhythmia the ICC classified as NYHA ≥ II • Uncontrolled hypercalcemia;
* Uncontrolled infection;
* Any other comorbidity that the investigator's judgment is inappropriate for the study;
* Peripheral neuropathy\> grade 2;
* Hearing loss\> grade 2;
* Known positive serology for hepatitis B, hepatitis C or HIV
* Use of antiretrovirals;
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.

Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.

Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.

Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy infants
* Infantile colic according to Roe IV criteria
* Full term infants
* Birth weight 2500 - 4000g
* Exclusively breast milk or partially breastfed
* Mothers last education degree is Senior high school

Exclusion Criteria

* Clinically suspected allergy
* Consumption of probiotics, antibiotics, PPI
* Failure to thrive
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 19 years
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

   * Blood pressure medication taken patients: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
   * Blood pressure medication free patients: 160mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
4. Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
3. Secondary hypertension patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia(Ca ≥ 10.5mg/dL)
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia

Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.

This study is a comparison of two devices used to teat transverse fractures of tibia and these include intra medullary rod popularly known as intra medullary nail and the second is a weight bearing device know as dynamic compression plate which is fixed with screws to diaphyseal segment of bone.

Eligibility Criteria:
Inclusion Criteria:

- Patients with closed transverse tibial fractures

Exclusion Criteria:

- Patients unsuitable for surgical intervention
To Investigate Agreement Between the EM-3000 and the Predicate Device Noncon Robo Pachy (F&A) (CellChek XL)

The purpose of this study is to evaluate the precision and agreement of the study device, a specular microscope, in comparison to a currently commercially available specular microscope in establishing substantial equivalence of the two devices in clinical use for diagnostic purposes of the human cornea.

The observational clinical investigation is intended to measure agreement between two diagnostic instruments of the eye's corneal endothelium. The study device is the EM-3000 specular microscope and the control device is the NonCon Robo Pachy (F\&A) (CellChek XL) specular microscope. Both instruments measure corneal endothelial cell layer parameters including cell density, coefficient of variation, percent hexagonality, and central thickness.

The primary variable is the measurement of agreement between the two instruments for the four parameters described. The secondary variables include repeatability (intra-investigator) and reproducibility both inter-investigator, and inter-instrument.

Additionally, measurements of agreement will be made on the EM-3000 using automated analysis with and without touch-up.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with one of the following corneal conditions:

Non-pathologic younger eyes (18-50 yrs) Non-pathologic older eyes (51-80 yrs) Pathologic adult eyes (29-80)

Exclusion Criteria

1. Seriously ill or unconscious subject, mentally ill person, mentally handicapped person, person who is unable to read or write.

   * Non-Pathologic subjects who have the following conditions :
2. History of corneal transplant
3. Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
4. Guttata
5. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device
6. Long term PMMA contact lens use longer than 5 years

   -Pathologic subjects
7. Keratoconus
Everolimus Versus Placebo in Head and Neck Cancer

Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
* 18 years or older.
* Performance status 70% or better.
* Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent.

Exclusion Criteria:

* Currently receiving anti-cancer treatment.
* Major surgery or traumatic injury within 4 weeks.
* Radiotherapy related toxicities.
* Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
* Receiving other investigational drugs.
* Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
* Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
* Show evidence of disease (cancer).
* Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
* Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
* Active, uncontrolled severe infections
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Known History of HIV positivity.
* Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
* Patients with an active, bleeding diathesis.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
* Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.

contraception, during the study and for 8 weeks after the end of treatment

* Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
* History of noncompliance to medical regimens.
* Patients unwilling to or unable to comply with the protocol.
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma

To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma


Eligibility Criteria:
Inclusion Criteria:

* A diagnosed history of asthma for at least 6 months
* Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
* FEV1 \>70% of predicted normal value (post-bronchodilator value).
* Skin prick test positive to pollen, animal dander or house dust mite.

Exclusion Criteria:

* Any significant respiratory disease, other than asthma.
* Upper or lower respiratory tract infection within 4 weeks before inclusion.
* Use of:

  1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
  2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
  3. regular NSAIDs
Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II

This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.


Eligibility Criteria:
Inclusion Criteria:

* Ages18 to 34
* Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);
* Ability to read English at an 8th grade level or higher; and
* No immediate plans to quit using tobacco
* \> 1 prior experience, even 1 puff, with a flavored tobacco product
* U.S. Citizen or permanent resident of the United States.

Exclusion Criteria:

* Current use of nicotine replacement therapy (NRT) or stop smoking medication;
* Pregnant, planning to become pregnant, or currently breastfeeding;
* Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
* Inability to abstain from nicotine/tobacco products for at least 12 hours prior to lab sessions
* Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
* Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.
Laser Treatment of Reticular Leg Veins Vs. Sclerotherapy

Treatment of reticular veins with a 1064 nm long-pulsed Nd:YAG laser and combination of a 1064 nm Nd:YAG long pulse laser and sclerotherapy should be no less effective than sclerotherapy alone, and have a frequency of adverse events less then sclerotherapy alone.

Reticular leg veins are mostly an aesthetic problem. Sclerotherapy is considered the gold standard for treatment them. However, this method has a high frequency of long persistent hyperpigmentation which decreases the patients' satisfaction. It is a reason to find another method of treatment. Another possible technique to treat reticular veins is the Nd:YAG long pulse 1064 nm transdermal laser or Nd:YAG laser combined with injection sclerotherapy. There are a few studies comparing sclerotherapy with laser treatment and combined treatment with sclerotherapy. But there are no prospective, randomized, comparative clinical trials of all three methods: the 1064 nm Nd:YAG long pulse laser, combined treatment of a 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone. The aim of current study is the efficacy assessment of the 1064 nm long-pulsed Nd:YAG laser, combined treatment of the 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone for the treatment of reticular leg veins and analysis of side effects to establish advantages and disadvantage of these methods and find the best option for treatment of reticular leg veins.

Eligibility Criteria:
Inclusion Criteria:

* women over 18
* reticular veins
* signed informed consent to participate in the study

Exclusion Criteria:

* diabetes mellitus
* pregnancy or lactation
* malignant neoplasms
* inability or unwillingness of the patient to wear compression stockings
* hypersensitivity to the polidocanol, cold, sunlight
* concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena,
* known hereditary thrombophilia.
* period after treatment of alcoholism
* reception of oral contraceptives
* sedentary lifestyle
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.

AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received \< 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed for all patients:

* Standard prophylaxis for opportunistic infections.
* Continuation of treatment for opportunistic infection.

Allowed for open-label study patients:

* Rifampin.

Patients must have:

* HIV positivity.
* CD4 count \<= 50 cells/mm3.
* More than 6 months of prior AZT (blinded study only).

NOTE:

* Patients on the open-label study must have AZT intolerance or have \< 6 months of prior AZT.

Prior Medication:

Required for blinded study patients:

* \> 6 months of prior AZT.

Required for open-label study patients:

* \< 6 months of prior AZT.

Allowed for open-label study patients:

* Prior 3TC.

Exclusion Criteria

Concurrent Medication:

Excluded in all patients:

* Immunosuppressants.

Excluded in blinded study patients:

* AZT, ddI, ddC, or d4T.
* Rifampin.

Excluded in open-label study patients:

* 3TC.

Prior Medication:

Excluded in all patients:

* Prior protease inhibitors.
* Investigational agents and immunomodulators within 30 days prior to study entry.
* Immunosuppressants within 2 weeks prior to study entry.

Excluded in blinded study patients:

* Any prior 3TC.
* AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.

Excluded in open-label study patients:

3TC within 30 days prior to study entry.