cyrilzakka/clinical-trials huggingface dataset:
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome

The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center
* Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available

Exclusion Criteria

* Patients diagnosed with early stage MF/SS (Stages IA-IIA) before progressing to advanced stage
* Patients diagnosed with advanced MF/SS more than 6 months prior to initial presentation to the participating center
* Exclude one-time consultation type of new patients.
P Gingivalis Oral Infection, Intimamedia Thickening in Infants, Atherosclerosis

To determine if there is an association between Porphyromonas gingivalis infection of dental gingiva during primary tooth eruption and thickening of the radial artery intimamedial layers. Thickening of these layers in infants could be a promoting factor for later development of atherosclerosis.

Specific Aim 1. To determine the presence of Pg in the mouth of edentulous pre-eruption and then teething infants.

Over a 9-month period 15 normal babies will be recruited for a prospective pilot study from Creighton University students. Cotton swabs of the tongue mucosa and dental plaque will be made to detect the presence of Pg by DNA analysis.

Specific Aim 2. To determine the daily temperature of infants. Daily child temperatures will be recorded by the parent. Specific Aim 3. To measure the thickness of the radial artery using a 50 MHz ultrasound probe.

A 50 MHz ultrasound scan will be made by a trained dental hygienist of the left radial artery at an initial visit and at 3-monthly intervals to measure IMT.

Eligibility Criteria:
Inclusion Criteria:

* Pre-primary tooth eruption infants in the range of 4-8 months -

Exclusion Criteria:

* No erupted teeth. No diabetes, obesity, chronic inflammatory disorders, hyperlipidemia, -
Effect of Foot Reflexology on Preeclampsia

the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (\> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).

Eligibility Criteria:
Inclusion Criteria:

* Their ages were ranged between 20-36 years old.
* Their body mass index was not exceeding 35 kg/m2.
* All women were diagnosed as mild preeclampsia.
* All women were primipara and multipara.

Exclusion Criteria:

* Any fractures in foot.
* Foot ulcer \& infection.
* Open skin wound in foot.
* History of stroke.
* Women less than 20 years and more than 36 years.
* BMI more than 35 Kg\\m2.
* Severe preeclampsia.
Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea

The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.

The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.

Primary Objective

* To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care.
* To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI).

Secondary Objective

* To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life.
* To determine if metabolic parameters (e.g., lipids, glucose) improve.
* To determine if there is improvement in sleep structure and oxygenation during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea
* Patients with an age over 18 years
* Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA)
* Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2
* Patients who have an Epworth Sleepiness Scale score ≤11

Exclusion Criteria:

Patients will not be recruited:

* if they are on weight loss medications
* if they have seen a registered dietician in the preceding 6 months for dietary counseling
* if they have attended a weight loss program in the last 6 months
* if they have a history of a car accident related to sleepiness or report sleepiness when driving
* if they work in a safety critical occupation and require treatment for work reasons
* if they have serious or unstable cardiac co-morbidity
* if they are unable or unwilling to provide informed consent
* if they are pregnant
* if they are unwilling to return for follow-up visits
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study

This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.

During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. The investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of bone turnover and fractional excretion of calcium.

Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the Clinical \& Translational Research Center at the University of Pittsburgh Medical Center (UPMC) Montefiore

Exclusion Criteria:

* Pregnancy
* Any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological, malignant or rheumatologic diseases
* Body mass index great than 30
* Anemia
* Significant alcohol or drug abuse
* Baseline hypotension or hypertension
* Abnormal screening labs
* Use of certain chronic medications excluding oral contraceptives
* Receiving an investigational drug in the last 90 days
* Previously receiving PTH or PTHrP
* African-American race
Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit

Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.

Support of prolactin and oxytocin hormones is needed for adequate production and secretion of breast milk. Many factors affect the levels of oxytocin and prolactin in the blood, such as the health status of the mother and the baby after birth, their separation for a while, nutrition, light, stress, fear, and lack of social support. Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35,
* The baby is still in intensive care,
* Gave birth at 34 weeks of gestation and above,
* The baby was taken to intensive care within the first 3 days after birth,
* The baby will stay in the neonatal intensive care unit for at least 3 more days,
* The baby has started breastfeeding,
* Giving breast milk to the baby by expressing it,
* Not using any medication that will affect milk quantity,
* Does not have a psychiatric disease that will affect breastfeeding in the postpartum period,
* Availability by phone, language, etc. Mothers who do not have communication problems.

Exclusion Criteria:

* Not between the ages of 18-35,
* The baby is discharged from intensive care,
* Those whose gestational age is less than 34 weeks,
* The baby is taken to intensive care after the first 3 days after birth,
* The baby is in the neonatal intensive care unit for at least 3 days,
* The baby has not started breastfeeding,
* Breastfeeding,
* Those who use medication that will affect the amount of milk,
* Having a psychiatric disease that will affect breastfeeding in the postpartum period,
* Mothers with communication problems.
Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma

The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients

This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical trial design. During a screening epoch patient eligibility will be assessed. The screening epoch will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication. After the Run-in period patients will be randomized to one of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment period one is followed by a 10 to 14 days washout period after which patients begin the second 7-day treatment period which is then followed by a second 10 to 14 days washout period followed by the third 7-day treatment period. At the end of each treatment period spirometry will be performed to assess the primary endpoint in terms of trough FEV1. The study population will consist of approximately 144 patients with asthma who have been treated in a stable regimen of ICS/LABA for at least 4 weeks prior to screening.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients aged \>= 18 or =\< 65 years
* Patients with a diagnosis of asthma for a period of at least 1 year receiving daily treatment of ICS/LABA in a stable regimen for \>= 4 weeks
* Pre-bronchodilator FEV1 of \>= 50% and =\< 80% of the predicted normal value and an increase in FEV1 of 12% and \>= 200 ml during reversibility testing

Key Exclusion Criteria:

* Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks
* Patients who have had a respiratory tract infection within 4 weeks prior to screening.
* Patients who have smoked or inhaled tobacco products within the past 6 month of screening.
* Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).
* Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.
* Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.
* Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy).
Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study

This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.

The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent
* Vaginal delivery
* Postpartum hemorrhage due to suspected uterine atony
* Able and willing to give informed consent

Exclusion Criteria:

* Known allergy to misoprostol or other prostaglandins
* Underwent a c-section during the current delivery
* Unable to provide informed consent due to mental impairment, distress during labor or other reason
* Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)

The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
* BMI between 18.5 and 40
* Ability to read, write, speak, and understand English and/or Spanish.
* Ability to provide informed consent.
* Willingness to consume provided dietary interventions.
* Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. Hemoglobin ≥9 g/dL (transfusions permitted) Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For subjects with Gilbert's disease ≤3.0 mg/dL. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN. Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation.

Exclusion Criteria:

* Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial.
* Previous intolerability to fiber-rich diets.
* Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
* Food allergies or other major dietary restrictions.
* Receiving active medical treatment for Type I or Type II diabetes mellitus.
* Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
* Undergone any type of weight loss surgery.
* Any medical contraindications as determined by investigators.
* History of diabetic ketoacidosis.
* History of Gout.
* Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
* Gallbladder removed or plan to remove per clinician evaluation.
* Other malignancies actively receiving systemic treatment as per clinician evaluation.
* Previous treatment for prostate cancer.
* Previous history of pelvic radiation.
* Patients with impaired decision-making capacity.
Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome

Hand functions are decreased in rheumatic diseases such as systemic sclerosis and rheumatoid arthritis.

Sjögren's syndrome (SS) is a chronic systemic rheumatic disease characterized by lymphoplasmacytic infiltration of exocrine glands, especially salivary and lacrimal glands.

SS may be "primary" when it occurs alone (pSS) and "secondary" (sSS) when associated with another autoimmune disease. PSS is the most common connective tissue disease after rheumatoid arthritis and affects 0.3-3% of the population. Joint involvement is the most common involvement of pSS after sicca syndrome (50% of patients). Patients may have arthralgia with inflammatory features (morning stiffness \> 30 minutes) or, less frequently, true symmetric polysynovitis mimicking rheumatoid arthritis (RA). The joint involvement of PSS is usually moderate (\<5 affected joints) and mostly affects the small joints of the hands and upper extremities. PSS may also be responsible for myositis. Widespread pain, similar to primary fibromyalgia, is common in about 50 percent of patients with PSS.

The hand is one of the most important components affecting the functionality of the upper extremity. Grasping is one of the hand functions, for the continuity of daily living activities.

is an important function. Studies have shown that hand grip strength is correlated with upper extremity muscle strength, as well as general body muscle strength and pulmonary muscle strength.

As far as we know, hand functions have not been evaluated in newly diagnosed patients with pSS.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients aged 18-65 years diagnosed with Primary Sjogren's 2. Patients with normal cognitive functions

Exclusion Criteria:

* 1. Other connective tissue diseases other than primary Sjögren's 2.Pregnancy 3.Malignancy 4. Chronic diseases (DM, HT, Hypothyroidism, hyperthyroidism) 5. Cognitive disorder 6. Neurological or traumatic hand disorders leading to hand disorders (MS, Trauma, SVO) 7. Patients who have undergone major salivary gland surgery, have Graft Versus Host disease, have received Sarcoidosis, Head and Neck Radiotherapy, have a history of HTLV-1 or HIV
Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum

The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery

MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. The balance between tissue inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the integrity of healthy periodontium.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)

Exclusion Criteria:

* (a) any known systemic disease, (b) periodontal treatment within the last six months, (c) patients having less than 10 teeth, (d) smokers and (e) individuals with BMI \> 30 kg/m2