cyrilzakka/clinical-trials huggingface dataset:
A Study of Efficacy and Safety With the Transdermal Contraceptive System.

The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.

This is an open-label, multicenter, global study to evaluate the contraceptive efficacy, cycle control, safety, compliance and subject satisfaction of the transdermal contraceptive system. Sixteen hundred healthy women will wear the contraceptive patch for either 6 or 13 cycles. The first 530 subjects will wear the patch for 13 cycles, and all subsequent subjects will wear the patch for 6 cycles. At admission Visit 1, study drug (plus 3 reserve patches) and diary cards are dispensed for Cycle 1; first patch application will be on the first day of menses. Study drug and diary cards are dispensed on day 28 of Cycle 1 (Visit 2) for Cycles 2 and 3, on day 28 of Cycle 3 (Visit 3) for Cycles 4 to 6, on day 28 of Cycle 6 (Visit 4) for Cycles 7 to 9, and on day 28 of Cycle 9 (Visit 5) for Cycles10 to13. At each of these visits, diary cards and empty medication packages are collected. Final study visits are on day 28 of Cycles 6 and 13. Diary card information is used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy is assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations are based on adverse events, which are collected throughout the study, and changes in gynecologic examinations, vital signs, and laboratory results from admission to final visit. Each transdermal contraceptive patch, containing 6 mg NGM and 0.75 mg EE, and delivering 250 ug 17-dNGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. The patch can be worn on: upper arm or torso, buttock, or abdomen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women with regular menstrual cycles
* sexually active and at risk of pregnancy
* nonpregnant
* acceptable body mass index (BMI)
* last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
* sitting BP\<140mmHg/\<90mmHg
* 1 normal menstrual cycle since removal of IUD or norplant
* agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
* agree not to use other systemic steroid medication

Exclusion Criteria:

* Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
* cerebral vascular or coronary artery disease, hypertension, or severe migraines
* liver tumor resulting from estrogen-containing products
* diabetes mellitus
* cholestatic jaundice, liver or renal disease
* abnormal PAP smear
* thyroid disorder
* dermal hypersensitivity
* carcinoma of breast, endometrium or other estrogen-dependent neoplasia
* substance abuse
* received experimental drug within prior 30 days
* smoking women over 35 years of age.
Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

Higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Many topical agents such as local and systemic an- tibiotics, local antiseptics, topical NSAIDs, and topical corticosteroids are generally prescribed for symptomatic relief. Several approved drug for- mulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer.

Camel whey protein gel was fabricated to get benefits of its antiinflammatory, immunomodulator, Antibacterial and antioxidant effects.

40 cases of recurrent aphthous ulcer patients as the research object,were randomly divide into the study group and the control group, each with 20 cases of both sexes with age ranging from 18 years to 50 years.

Inclusion criteria consisted of the following: (a) clinical examination and confirmed history of recurrent oral ulcer, (b) recurrence of the oral ulceration, and (c) patients in good condition with no serious systemic disease. Eligible persons were excluded if they were administered antibiotics or glucocorticoids or accepted periodontal or dental treat- ments that interfered with the results of our experimental drugs.

the control group will be subjected to placebo gel consisting of methyl cellulose gel whereas the study group will use camel whey protein dissolved in methyl cellulose gel base. the gel will be applied 1 day after ulcer appearance and will be stopped after ulcer disappearance

Eligibility Criteria:
Inclusion Criteria:

* clinical examination and confirmed history of recurrent oral ulcer,
* recurrence of the oral ulceration
* patients in good condition with no serious systemic disease.

Exclusion Criteria:

* if they were administered antibiotics or glucocorticoids
* accepted periodontal or dental treat-ments that interfered with the results of our experimental drugs
A Study of RO5310074 in Patients With Psoriatic Arthritis

This randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with psoriatic arthritis who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 - 75 years of age
* Diagnosis of Psoriatic Arthritis (Moll and Wright or CASPAR criteria) of \>/= 6 months duration
* Have \>/= 3 swollen and \>/= 3 tender joints
* Inadequate response to a current or previous oral DMARD or NSAID therapy
* Current oral DMARDs must be at stable dose for the appropriate duration (e.g. 14 days for sulfasalazine and 28 days for methotrexate or oral steroids)
* NSAIDs up to maximum recommended dose are permitted if at stable dose for at least 14 days prior to first dose of study drug, but not more than one NSAID simultaneously (except for low-dose aspirin for cardioprotection)
* Body mass index (BMI) 18 - 42 kg/m2 inclusive

Exclusion Criteria:

* Previous prolonged treatment with a biologic DMARD; use of biologic DMARD within 3 months or 5 times its elimination half-live (whichever is longer) prior to first dose of study drug
* Previous use of B-cell depleting biologic DMARDs
* Any previous treatment with alkylating agents such a cyclophosphamide or chlorambucil or with total lymphoid irradiation
* History of or current inflammatory joint disease other than psoriatic arthritis; Gout or pseudogout that is current or has been active within the past 6 months
* Positive for hepatitis B, hepatitis C or HIV infection
* Any acquired or congenital immune deficiency or history of disease known to cause significant alteration in immunologic function
* Acute clinically significant infection in the 6 weeks prior to administration of study drug, history or presence of chronic infection, or history of recurrent infection as an adult
Efficacy of Platelet-rich Plasma in Treatment of Melasma

The application of Platelet Rich Plasma (PRP) on three occasions with an interval of 15 days between each one, is related to a decrease in the intensity of the spots and improvement in the quality of the skin of patients with melasma.

832/5000 Objective: To evaluate the effect of PRP for Melasma treatment. Material and methods: Prospective cohort with therapeutic intervention. Patients, female, with melasma were included. Changes in the melanin concentration of the face (MASI), degree of satisfaction (MELASQOL) and histological changes were clinically evaluated.

The Sp-MELASQOL questionnaire, Fitzpatrick and MASI scales were applied, and photographs were taken with ambient light and with Wood's light with the Janus-II General Model. The patients were evaluated and classified, before and after the treatment by means of dermatoscopy, which was performed using a dermatoscope with polarized light (DermLite DL3N®), which allows an increase from 6 to 400X.

The dermatoscopy reported the findings of: Quantity, Density and Depth of melasma.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of melasma
* History of pregnancy with a time greater than 6 months
* Informed consent

Exclusion Criteria:

* In lactation period
* History of skin cancer
* History of liver, thyroid diseases
* With active acne lesions and traumatic lesions on the face
* PRP pre-treatmentPre-treatment for melasma with less than 6 months
* Hb values \<10 g / dL or platelet count \<105x109 / L
Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.

The study was designed to test the following hypotheses:

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Background:

In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1 L/min to the baseline oxygen flow during exertion, a new closed-loop system (FreeO2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (SpO2), end-tidal CO2 (EtCO2) and respiratory rate. A preliminary study showed significant improvement in exercise tolerance in COPD patients not needing oxygen therapy. Although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe COPD.

Aim of this study is to evaluate this system during endurance shuttle walking test in COPD patients with oxygen therapy and hypercapnia.

Methods: The investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Eligibility Criteria:
Inclusion Criteria:

* 40 Years and older
* Patient with COPD severe to very severe requiring long-term Oxygen Therapy
* Hypercapnia (PaCO2 \> 45mmHg)
* Former or current smoker greater than or equal to 10 pack-years

Exclusion Criteria:

* Pregnant or breast-feed woman
* Patients under guardianship
* Imprisoned patients
Trial of An Innovative Smartphone Intervention for Smoking Cessation

The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit cigarette smoking in the next 30 days
* if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
* interested in learning skills to quit smoking
* willing to be randomly assigned to either condition
* resides in US
* has at least daily access to their own personal Apple iPhone, Android, or Windows Phone
* knows how to login and download a smartphone application
* willing and able to read in English
* not using other smoking cessation interventions (including apps or our other intervention studies).
* willing to complete all three follow-up surveys
* provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are opposite of the inclusion criteria listed above.
Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Karnofsky performance status \>/= 70%
* Pathologic diagnosis of malignant pleural mesothelioma at MSK
* Positive immunohistochemical staining for WT-1 within 60 days of treatment start
* Patients must have received at least one prior course of pemetrexed-based chemotherapy
* Patients of childbearing potential must have a negative serum pregnancy test within 24 hours of receiving the first treatment on the study (if female) and must be practicing an effective form of birth control for the entire duration of treatment (both females and males)
* Has received and progressed or are refractory to pemetrexed based chemotherapy
* Measurable or evaluable disease
* Biochemical parameters: Total bilirubin \< 1.5 mg/dl, AST and ALT \< 3.0 x upper limits of normal, Creatinine \< 1.5 x upper limits of normal

Exclusion Criteria:

* Pregnant or lactating women
* Prior receipt of checkpoint inhibition
* Patients with known active hepatitis B or known active hepatitis C virus
* Patients with a serious unstable medical illness or another active cancer
* Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Autoimmune disease requiring treatment with systemic steroids in the past 2 years
* Current use of systemic corticosteroids at doses greater than prednisone 10 mg daily or the equivalent
* Patients with active pneumonitis
* Hematologic parameters: Absolute neutrophil count \>/= 1000/mcL
* Platelet count \<100,000
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation

In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.


Eligibility Criteria:
Inclusion Criteria:

* First kidney transplantation
* Male and female patients
* Between 18 and 65 years old

Exclusion Criteria:

* Patient in need of multi-organ transplant
* Patients with history of cardiac arrest
* Patients with any past or present malignancy
Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach

This study seeks to determine whether a patient navigator can help improve follow up care after a stool test shows the presence of blood or other abnormal markers.

Participants who recently had a stool test that had abnormal results will be asked to participate in this study in order to determine whether the use of a navigator can increase the use of colonoscopy, which is the recommended follow up to an abnormal stool test. A navigator is an individual trained to help patients access necessary health care services and understand the test results and next steps. Participants will be asked to meet the navigator at their colonoscopy appointment and discuss any problems that are experienced in getting the colonoscopy done. This will take about 10 minutes to complete. Participants will tell him or her in their own words how the experience was and whether they faced any barriers to scheduling and colonoscopy completion. Study personnel will also look at participants' electronic medical record to see what testing participants had done that prompted the need for colonoscopy.The study will include about 30 people.

Eligibility Criteria:
Inclusion Criteria:

• Positive test for FIT or sDNA

Exclusion Criteria:

• Does not understand English
VEINEX : Venous Investigations During Exercise

Successfully develop and confirm with the Higher School of Electronics West Plethysmographic a multichannel recorder to perform measurements staggered volume of the lower limbs at rest, walking and recovery (6 storied measures on members lower).

Validate the measurement made by EAP (Electroactive polymer) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.

Eligibility Criteria:
Inclusion Criteria:

* present or not venous pathology

Exclusion Criteria:

* amputation of a lower limb
* heart failure
* Severe respiratory disease
* Unstable angina or myocardial infarction
* Parkinson's disease, hemiplegia and paraplegia
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.


Eligibility Criteria:
Inclusion Criteria:

* close contact with active TB patients
* patients with autoimmune diseases preceding biological therapy
* health-care workers
* other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.

Exclusion Criteria:

* age less than 20 years
* pregnant women
* active TB or suspected active TB in the clinical evaluation
* severe liver disease
* ESRD
* organ transplantation
* close contact with a multidrug-resistant TB patient
* obesity (BMI\>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin

The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.

To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control.

Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* insulin therapy \> 1 year
* residual ß-cell function (C-peptide increase in iv glucagon test)
* written informed consent

Exclusion Criteria:

* type 1 diabetes
* oral therapy
* life-threatening disease
* heart failure (NYHA I-IV)
Understanding the Impact of Neighborhood Type on Physical Activity in Older Adults

The purpose of this study is to investigate whether seniors living in neighborhoods that are conducive to walking are more physically active than those living in neighborhoods that are less conducive to walking.

BACKGROUND:

Despite the recognized benefits of regular physical activity for older adults, people over the age of 65 remain among the most inactive groups of the U.S. population. Efforts to understand the factors influencing physical activity in this important group have been limited primarily to demographic and psychosocial domains. The importance of the neighborhood environment in influencing a host of health, behavioral, and psychosocial outcomes has been recognized. However, to date, no systematic investigation of the relationship between objective and subjective environmental factors and objectively measured physical activity levels among older adults has been undertaken.

DESIGN NARRATIVE:

This observational study will investigate whether seniors living in neighborhoods conducive to walking are more physically active, after adjusting for socioeconomic status (SES), than those living in neighborhoods less conducive to walking or other forms of physical activity for transportation or recreational purposes. Additional questions of interest concern the moderating effects of physical function and the proportion of seniors living nearby on the relationship between environment and physical activity. The study will take advantage of the sampling, recruitment, and data collection methods of an ongoing NIH-funded research project aimed at integrating public health and urban planning frameworks in studying the impacts of environmental factors on physical activity levels in younger adults. Population-based sampling methods will be used to recruit adults over 65 years of age who are living in more walkable versus less walkable neighborhoods of varying SES levels. Participants will be recruited from Seattle, Washington (n = 600) and Baltimore, Maryland (n = 600). In addition to objectively measured physical environment (using geographic information systems {GIS}) and physical activity levels (using accelerometry), self-reported neighborhood environment, physical activity, and quality of life variables of particular relevance to older adults will be assessed twice during a 12-month period.

Eligibility Criteria:
Inclusion criteria:

* Currently living in an apartment, condo, house, or assisted living facility
* Able to walk more than 10 feet at a time
* Able to speak and read English
* Able to complete study surveys (with assistance if necessary)

Exclusion Criteria:

* Not currently living in one of the areas in which the study will take place
A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
* Best corrected visual acuity of 20/200 Snellen or better in each eye.
* Intraocular pressure within protocol-specified range.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any abnormality preventing reliable applanation tonometry in the study eye(s).
* Any eye conditions or procedures as specified in protocol.
* Progressive retinal or optic nerve disease from any cause.
* Use of contact lenses in the study eye(s).
* Other protocol-defined exclusion criteria may apply.