cyrilzakka/clinical-trials huggingface dataset:
Effects of Connective Tissue Massage in Patients With Fibromyalgia

Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group.

Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. It is often associated with symptoms such as decreased physical strength, fatigue, sleep disturbances, gastrointestinal disorders and psychiatric disorders such as depression. Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. In the last two decades, massage applications using tools of various densities, materials, shapes and sizes (such as Foam Roller (FR), roller massagers, sticks or balls) and actively self-administered by individuals have rapidly gained popularity. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group. Treatments will be applied for 6 weeks, 2 days a week for a total of 12 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Being a woman
* Being diagnosed with FMS,
* Being between the ages of 18-65 and volunteering.

Exclusion Criteria:

* Neurological, infectious, endocrine and other inflammatory rheumatic diseases, severe psychological disorders, any condition that prevents exercise (advanced cardiac respiratory or orthopedic problems),
* Malignancy
* Being pregnant
Digital Analysis of Mesiodistal Tooth Width

the goal of this cross-sectional study is to determine the digital permanent crown tooth width

using digital intra oral scanning to measure the permanent tooth mesiodistal dimension

Eligibility Criteria:
Inclusion Criteria:

* Children range age 12-15 years old.
* Complete set of permanent dentitions with intact marginal ridges.
* Fully erupted teeth to the occlusal plane.
* Normal occlusion without crowding, rotation, Spacing.
* Healthy children with no systemic diseases.

Exclusion Criteria:

* Buildups, Crowns, onlays, class II restorations that affect a tooth mesiodistal
* diameter.
* Congenital defects or deformed teeth or congenital missing Teeth.
* Obvious interproximal or occlusal wear of teeth.
* Anterior teeth fractures.
Anemia of Prematurity and Hemodynamics

The aim of this work to study the hemodynamic changes accompanying anemia of prematurity in neonates with gestational age ≤32 weeks and the effect of its treatment on hemodynamics.

This prospective observational study aims to evaluate the hemodynamic changes provoked by anemia of prematurity and transfusion of packed red blood cells (RBCs). Nonanemic inpatient premature infants (Hematocrit\>30%) will be compared with pretransfusional anemic inpatient premature infants. Anemic premature infants will be assessed before and 24 hours after the transfusion of pRBCs. Cerebral, intestinal and renal blood flow velocities, cardiac output parameters will be measured in premature neonates who will fulfill the eligibility criteria of the study.This study will be conducted at the neonatal intensive care units in Alexandria University Hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.

Exclusion Criteria:

-
Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Resistant Nephrotic Syndrome

The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 20% experience a more complicated course with steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. In order to minimize the side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in SRNS. Whereas CNI are usually considered the steroid sparing drug class of first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign. Studies comparing the usefulness of these agents are lacking. In this proposed randomized controlled trial, the investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating children with SRNS.


Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 16 years with SRNS
* Minimal Change disease/Messengioproliferative glomerulonephritis/Focal segmental glomerulosclerosis as per Kidney Biopsy report.
* Estimated glomerular filtration rate (eGFR) \>80 ml/min per 1.73 m2 at study entry.
* Not received any steroid sparing agent previously.
* Parents willing to give informed written consent.
* Ability to swallow tablet

Exclusion Criteria:

* Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
* Patients with severe leucopenia (leucocytes \<3.0× 1000 cells/mm3), severe anemia (haemoglobin \<8.9 g/dl), thrombocytopenia (platelet \<100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to \>50 IU/L ) at enrolment.
* Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
* Live vaccination within 1 mo
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.

PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.

OBJECTIVES:

* Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI following treatment.
* Identify those cellular antigens which are altered by hormonal therapy.
* Determine which cellular antigens are predictive of clinical response to hormonal therapy.
* Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment.

OUTLINE: This is a pilot study.

Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity.

After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy
* No evidence of contralateral breast disease or palpable masses on breast examination
* No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI
* No documented ipsilateral axillary adenopathy
* Planning to undergo lumpectomy or mastectomy
* Estrogen receptor (ER)-positive tumor by immunohistochemistry

PATIENT CHARACTERISTICS:

* Female patient
* Premenopausal or postmenopausal

  * Postmenopausal is defined by any of the following:

    * No spontaneous menses for \>= 1 year
    * Bilateral oophorectomy
    * Radiation castration and amenorrheic for \>= 3 months
    * Follicle-stimulating hormone (FSH) \> 20 IU/L AND off all hormonal therapy (e.g., hormone replacement therapy or birth control pills) for \>= 1 month
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No co-morbidities contraindicating the use of tamoxifen, including any of the following:

  * Prior history of thrombotic events
  * History of hypercoagulable state
  * History of endometrial hyperplasia
  * Abnormal vaginal bleeding
* No history of contrast dye-related allergies/reactions
* No history of metal-containing prostheses or implants

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion

This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion. The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain ratings, incidents of side effects and adverse events, the frequency of additional doses of medication, recovery room time, and physician assessment of and satisfaction with pain control. Investigators hypothesize that this algorithm will result in improved pain control, decreased frequency of additional medication doses, improved patient and physician satisfaction, without differences in side effects, adverse events or recovery room time.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older seeking surgical abortion at Planned Parenthood League of Massachusetts (PPLM)
* Gestational age less than or equal to 13+6, confirmed by ultrasound
* Eligible for surgical abortion according to PPLM protocols
* Eligible for IV sedation per PPLM protocol, and desiring IV sedation for pain management

Exclusion Criteria:

* Choice of local anesthesia for pain control
* Hypersensitivity to midazolam or fentanyl
* Ineligible for IV sedation per PPLM protocol
* Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
* Unable or unwilling to complete required study procedures
* Previous participation in the study
Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019

• This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in Sendero IdealCare health plan as of August 1, 2018
* Age 18 years or older

Exclusion Criteria:

* A coverage termination date listed prior to December 31, 2018.
* Sendero member records lack both a phone number and email address.
First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers

This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 40-65 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
* Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) at screening, and weighing at least 50 kg
* Nonusers of nicotine-containing products for at least the previous 3 months prior to dosing or nonsmokers
* Agreement to use birth control during the study and 3 months post last visit.
* Able to comply with all protocol requirements and procedures

Exclusion Criteria:

* Clinically significant abnormalities found during physical examinations, medical history review, ECGs (QTcF interval \> 450 milliseconds for males and \>470 milliseconds for females), vital signs, and laboratory tests (including positive HIV, hepatitis B and C)
* Participated in in a previous clinical study with an investigational product in the last 60 days
* History of any serious allergic reaction to any medication
* Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
* History of drug or alcohol abuse in the last 2 years
* Pregnant or lactating women
* Any other issues which, in the opinion of the PI, will make the subject ineligible for study participation
A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Dilatation of the cervix is necessary before operative hysteroscopic procedures. This dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical priming with various substances soften the cervix, ease the entry for the operation and decrease complications such as uterine perforation.

The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl bromide" with sham protocol.

The study is planned as a double blind randomised controlled one centre study. It will take part at a operative gynaecological department of a university hospital. Women who apply to the university clinic who have a medical indication for hysteroscopic surgery will be recruited after informed consent.

Patients included in the study will be allocated to three groups. The intervention arms will be two arms and one sham group. The randomisation will be performed to three groups by a third party who is not involved in the surgical procedures.

Upon initial evaluation, a form evaluating age and other sociodemographic characteristics will be filled out before the scheduled hysteroscopy procedure. After completion of the initial form, rectal tablets will be administered according to the allocated group; two hours previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm hysteroscope during the follicular phase of the menstrual cycle.

During the procedure the duration of the cervical entry and total duration of the operation will be noted. Additionally basal dilatation will be noted.

Two hours after the procedure pain will be documented according to the Visual Analogue Scale which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates "excruciating" pain.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive aged women
* Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae

Exclusion Criteria:

* Women who have undergone hysteroscopy previously
* women who are in menopause
Phase II Study Using Thalidomide for the Treatment of ALS

The use of Thalidomide in patients with ALS who have disease progression.

Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Clinically proven ALS
* Disease duration less than or equal to 5 years
* ALSFRS-R score equal to or greater then 30

Exclusion Criteria:

* Patients with known deep venous thrombosis or hyper coagulable state will be excluded
* Patients with FVC less than 80%
Investigation of the Effects of Pilates Exercises on Menopause Symptoms and Sexual Dysfunction in Postmenopausal Women

Menopause represents a major transition in a woman's life as estrogen and progesterone levels decline, and this hormonal shift is associated with a range of symptoms that can significantly impact a woman's quality of life, including vasomotor symptoms such as hot flushes and night sweats, and urogenital symptoms such as vaginal dryness and sexual dysfunction.

This study aimed to investigate the effects of Pilates exercises on menopausal symptoms and sexual dysfunction in postmenopausal women. The research seeks to understand how an 8-week Pilates program, conducted twice a week, influences the quality of life and sexual function during the postmenopausal period. A total of 30 postmenopausal women were included in this study, divided into a Pilates group and a control group. The Pilates group participated in an 8-week Pilates exercise program, while the control group received no exercise intervention but attended menopause information sessions. Data were collected using the Menopause Rating Scale (MRS), the Menopausal-Specific Quality of Life Scale (MENQOL), and the Female Sexual Function Index (FSFI) before and after the intervention. Body Mass Index (BMI) was recorded, but not used in the primary analysis.

Eligibility Criteria:
Inclusion Criteria:

* Women who have reached menopause
* Being physically or cognitively competent to exercise
* Those who agreed to participate in the study

Exclusion Criteria:

* Those with serious heart disease, DM, kidney, liver, thyroid disease and cancer patients
* Those receiving hormone therapy
* People using antipsychotic medication
* Those using steroids and derivative drugs
* People using insulin sensitizing drugs Those with musculoskeletal system diseases that would prevent them from exercising Cognitive problems that affect cooperation
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>40
* undergoing bariatric surgery

Exclusion Criteria:

* use of drug inducing or inhibiting CYP3A4 activity
* pregnancy, breastfeeding
* renl insufficiency
Relationship Between Diabetes and Cognitive Impairment Based on Olfactory Function Assessment and Functional MRI

The purpose of this study is to explore the relationship between diabetes and cognitive impairment by olfactory function assessment and functional MRI.

Previous research has shown both obesity and diabetes are associated with an increased risk of cognitive impairment. Meanwhile, olfactory impairment is associated with incident (amnestic mild cognitive impairment) aMCI and progression from aMCI to (Alzheimer disease) AD dementia. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, olfactory function and fMRI results are analysed to explore the differences among T1DM patients, T2DM patients and non-diabetic people . One the other hand, in the longitudinal study, changes in olfactory function and fMRI results in diabetic and non-diabetic obese patients both at baseline and 6 months after their bariatric surgery are collected to investigate whether better glucose and weight control benefit brain function.

Eligibility Criteria:
Inclusion Criteria:

1. Have a certain level of education (at least 6 years), able to complete the cognitive assessment;
2. Disease duration \>1 year.

Exclusion Criteria:

1. Control participants would be excluded if they had a fasting blood glucose level \>7.0 mmol/L; glucose level\> 7.8 mmol/L after oral glucose tolerance test (OGTT);
2. Montreal Cognitive Assessment (MoCA,Beijing edition) score of \< 20;
3. History of neurologic or psychological illness;
4. History of cardiovascular or cerebrovascular disease;
5. Abnormal results of thyroid hormones, vitamin B12, and folate.
6. Metal implants, unable to complete the MR examinations or evidence of cortical infarcts, hemorrhage, or structural brain disease other than atrophy, lacunes, or white matter lesions;
7. Left-handed;
8. Partial or complete olfactory dysfunction associated with sinusitis,allergic rhinitis, and deviated nasal septum.
Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study

Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome, and sexual dysfunction. Several studies have indicated effects of ginseng on improving spermatogenesis in animals. The major mechanisms behind these effects were speculated to be anti-oxidant and anti-aging effects, as well as modulation of the hypothalamus-pituitary-testis axis \[7 - 10\]. However, there have been no controlled human clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male infertility.

Only a small proportion of causes of male infertility are currently curable, including male hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia that can be corrected by surgery. In addition, evidence-based medicine has revealed that most empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens, kallikrein, vitamins C and E, and glutathione have not been confirmed.

Therefore, the investigators investigated the effects of KRG on semen parameters in male infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic effects of KRG in male patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be males, 25 - 45 years of age, who had complained of infertility for at least 12 months, and had no history of surgical or medical treatments for infertility.
* Increased retrograde flow in the internal spermatic vein with venous diameter \> 3 mm during the Valsalva maneuver on scrotal ultrasonography was used as an indicator of varicocele \[13\].
* Varicocele was graded according to the criteria presented by Lyon et al. \[14\]: \*Grade I, palpable only with the Valsalva maneuver

  * Grade II, palpable without the Valsalva maneuver
  * Grade III, visible from a distance.

Exclusion Criteria:

* A history of vasectomy or obstructive azoospermia
* Chromosomal abnormalities
* Hypogonadism or pituitary abnormalities
* Anatomical abnormality of the genitals
* Significant hepatopathy (liver enzymes elevated 2 - 3-fold higher than the normal range)
* Renal insufficiency (serum creatinine level \> 2.5 mg/dL)
* Medical treatment for infertility during the past 4 weeks.