cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome

Premenstrual syndrome represents a group of problems affecting most of women in reproductive age. These problems include emotional and physical symptoms. In this study the efficacy of oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed .

Premenstrual syndrome (PMS) is deﬁned as the recurrence of psychological and physical symptoms in the luteal phase, which remit in the follicular phase of the menstrual cycle \[1\].PMS will be prospectively diagnosed using the Royal college of Obstetricians and Gynecologists (RCOG) recommended daily record of severity of problems (DRSP) . Women will be asked to fill the diary for 2 months, only women with 30% increase in the DRSP score in the week before menses in both months will be diagnosed as having PMS.

Women with PMS will be invited to participate in the study.The invitation will include a clear full explanation of the study and patients will provide written consents. All patients consenting to participate will be included in the trial.

Yasmin, Calver and Placebo will be enclosed in sequentially numbered similar bottles which will be numbered using a computer generated random table. Women will be asked to choose a sealed envelope, each envelope will contain the number allocated to the jar and special instructions on how to use the medication. Yasmin will be taken once daily for 21 days starting from the 2nd day of menstruation, Calver and placebo will be taken continuously. Neither the patients nor the physician will be aware of the drug used. Patients will be categorized in 3 groups: group1 who will receive Yasmin cyclically for 3 months (Yasmin, schering, cairo, Egypt) and daily oral placebo, group 2 who will receive Calver continuously for 3 months (Calver, Marcryl/Vertex, Cairo Egypt) and oral placebo for 21 days, group 3 who will receive a daily placebo and a placebo similar to COC for 21 days and will act as a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed by prospective dairy to have PMS
* Consenting to be included in the study
* Age 18-40 years

Exclusion Criteria:

* Medical disorders as hypertension or diabetes.
Effects of Cladribine Tablets on the PK of Microgynon®

The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).


Eligibility Criteria:
Inclusion Criteria:

* Are pre-menopausal women with or without child-bearing potential with a negative serum pregnancy test, and women with child-bearing potential receiving adequate birth control
* Participants with diagnosis of clinically stable and definite relapsing multiple sclerosis (RMS)
* Adequate hematological, hepatic and renal function as defined in the protocol
* Are able and willing to accept dietary restrictions and restrictions regarding the use of concomitant medications (including over-the-counter products, herbal medicines and dietary supplements) over the course of the study
* Had a body weight and body mass index (BMI) within the range at screening
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant allergy or known hypersensitivity to the active substance or to any of the excipients of cladribine tablets or hypersensitivity to drugs with a similar chemical structure to cladribine - History of clinically relevant allergy or known hypersensitivity to 1 of the active substances levonorgestrel (LNG) or ethinylestradiol (EE) or to any excipients of Microgynon® tablets
* Positive results from serology examination for Hepatitis B surface antigen (HbsAg) not due to vaccination, hepatitis B core antibody (HbcAb), Hepatitis C virus antibody (anti- HCV) or Human Immunodeficiency antibody (anti-HIV)
* Presence or risk of venous thromboembolism (VTE) arterial thromboembolism (ATE)
* Diabetes mellitus (Type 1 or Type 2) with vascular manifestations
* Signs or symptoms of neurological disease other than multiple sclerosis (MS) that could explain the symptoms of the participant
* Presence of gastrointestinal (GI) disease or history of gastrointestinal -tract surgery
* Exposure to another investigational drug within the last 2 months or within last 6 month if agent is known to be immunosuppressive
* Other protocol defined exclusion criteria could apply
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18

To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed concent obtained
2. At the time of obtaining informed consent, Ages ranged from over 20 to 80
3. At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded)

Exclusion Criteria:

1. TMP caused by burn or radiation therapy
2. In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
3. Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
4. No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
5. History of tympanoplasty
6. A Part of the eardrum adhered to tympanic cavity
7. By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
8. Abnormality in the chain and ear ossicles
9. Air-bone gap difference more than 25dB by patch hearing test
10. Unable to see whole edge of TMP due to narrow external auditory canal
11. Unable to wash out Ear drops during the treatment period
12. Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
13. Presenting with autoimmune disease
14. History of malignancy within 3 years prior to obtained informed concent
15. Administration of immunosuppressive agent or anti-cancer-agent
16. History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
17. Though out the period from screening to treatment, patient who is unable to wash out "Thrombolytic agent", "Anticoagulant", "Anti-platelet agent", "Procoagulant agent", "anti-line solvent"and"aprotinin formulation"
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia

The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).

In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.

Eligibility Criteria:
Inclusion Criteria:

* cervical neoplasia

  * HPV infection patient

Exclusion Criteria:

* no HPV infection

  * no intra-epithelial neoplasia lesion
B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading

The long-range goal of this proposal is to decrease morbidity and mortality related to pulmonary edema and congestive heart failure (CHF) in post-operative patients. The short-range goal is to determine a mechanistic endpoint when therapy for impending heart failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels. The investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.

Creighton University Medical Center is 334-bed Level I Trauma Center that hosts a wide variety of surgical and trauma patients. Many of these patients, including and especially those with pre-existing cardiac morbidities, develop symptoms of congestive heart failure (CHF) following trauma or surgical intervention because of a combination of physiological factors including third spacing followed by self-diuresis, and decreased contractility post injury. Normally, following the onset of CHF, surgeons begin treatment based on their clinical judgment of hemodynamic parameters and radiographic findings. CHF is known to increase morbidity, mortality, hospital length of stay and overall expenditure to the health care system and preventative measures and directed treatment modalities have potential to improve patient care and healthcare economics.

BNP, also known as beta-natriuretic protein or CHF peptide, is a cardiac neuro-hormone synthesized by the cardiac myocytes. It is released as a preproBNP peptide of 134 amino acids and is cleaved into proBNP (108 amino acids) and a signal peptide of 26 amino acids. ProBNP is subsequently cleaved into BNP (32 amino acids) and the inactive N-terminal proBNP peptide (NBNP; 76 amino acids). The effects of BNP are vasodilation, natriuresis and diuresis1.

Left ventricular end-diastolic wall stress (EDWS) measurement and ejection fraction are well established surrogates to predict the onset of CHF but require the invasive procedure of cardiac catheterization.

The mainstay of the treatment of CHF is diuretic drugs to try to remove excess fluid from the patient. In this project we plan to identify patients at risk for CHF and divide them into two groups. In one group BNP will be used to guide diuretic dosage and in the other conventional clinical parameters will be used.

Eligibility Criteria:
Inclusion Criteria:

* General Surgery patients with history of coronary artery disease, congestive heart failure, pulmonary hypertension
* Cardiac surgery patients undergoing CABG (coronary artery bypass grafting) and valve replacements

Exclusion Criteria:

1. Recent myocardial infarction (within 3 months).
2. ASA class 4 and more.
3. Emergency surgeries.
Wrist Worn Blood Pressure Measurement

In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors. The device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.

LiveMetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

The wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of Blood pressure.

The use does not require any special action from the user apart from wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet all the time or most of the time.

The study will include subjects that are hospitalized in the ICU and/or any of the cardiology departments or affiliating units such as Cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (A-line). A medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. A medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the A-line, providing the location of the placement has intact skin. During the measurement stage, BP values are simultaneously recorded from the reference invasive A-line and the wrist worn device.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
* Patients that are ≥18 years of age.

Exclusion Criteria:

* Body habitus that precludes patients from wearing a device on their wrist
* Subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise
* Subjects with wrist circumference less than 155mm or greater than 210mm
* Subjects implanted with pacemaker, VAD's or other mechanical circulatory support device whether intracorporeal or extracorporeal
* Patients that do not have an intra-arterial blood pressure line.
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.

Recent studies suggest that chronic right ventricular pacing is associated with a variety of adverse effects in patients, particularly those with intact or intermittent atrioventricular (AV) conduction.

Medtronic Adapta® pacemakers include Managed Ventricular Pacing®, a pacing mode designed to promote intrinsic conduction, and also Search AV™+, a feature designed to reduce unnecessary ventricular pacing in patients with intact or intermittent AV conduction.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated study informed consent
* Class I or Class IIa pacemaker indication
* Geographically stable and available for follow-up at the center for the length of the study
* Age greater than 18
* To be implanted with Adapta dual chamber pacemaker

Exclusion Criteria:

* Unwillingness or inability to give written informed consent to participate in the Study
* Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device
* Life expectancy of less than one year
* Patient has a mechanical tricuspid heart valve
* Medical conditions that preclude the testing requirement by the protocol or limit study participation
* Patient has persistent 3rd degree atrioventricular (AV) block
* Patient has persistent atrial fibrillation (AF)
* Patient has neurogenic syncope
* Patient has carotid sinus syndrome
* Patient has hypertrophic obstructive cardiomyopathy
* Inclusion in another clinical trial or study
Treatment Preferences in Patients With Low Back Pain

Together with the guidance of health professionals try to obtain information from media, popular magazines and books and the internet regarding diseases and treatment methods in patients with low back pain with the development of technology. In parallel with this information which they obtained, they turn to different treatment methods. This study was carried on examining how pain duration affects treatment preferences in patients with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65 with complaints of low back pain and no communication problems were included in the study.

Exclusion Criteria:

* Individuals with any systemic, neurological and / or orthopedic disease diagnosed other than complaint of low back pain were excluded from the study.
Health-related Quality of Life in a Cohort of Spanish Schoolchildren.

Background: Health-related quality of life (HRQoL) allows knowing the subject\&#39;s feelings in terms of distress and well-being, as well as her perception of her current and future health.

Objective: Evaluate the associations between health-related quality of life, physical state, and adherence to the Mediterranean diet in a cohort of Spanish children and adolescents. Methods: A cross-sectional study was carried out in a cohort of 305 (47.2% women) children and adolescents aged between 8 and 16 years, in the Primary and Secondary Schools of the province of Ávila (Spain). For the analysis of the different variables, the subjects were classified according to their quality of life in three groups from highest to lowest (Group 1 \&gt; Group 2 \&gt; Group 3).


Eligibility Criteria:
Inclusion Criteria:

* school children aged 8 to 16
* present the informed consent signed by the parents or legal guardians

Exclusion Criteria:

* serious illness that may influence the nutritional or functional status of the child, mental limitation of the parents and / or children that may hinder the completion of the questionnaire.
Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota

The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.

The secondary research objectives are:

* To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms.
* To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
* Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
* Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample

Exclusion Criteria:

* Pregnancy declared by the candidate
* History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:

  * Inflammatory Bowel Disease
  * Coeliac Disease
  * Pancreatitis
  * Gallstone disease (biliary colic, cholecystitis)
  * Diverticulitis
  * Cancer of the gastrointestinal tract
  * Irritable Bowel Syndrome
* Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
* Intestinal stoma
* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
* Use of antibiotics in the preceding four weeks other than for treatment of index infection.
* Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection.
* Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
* Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding
* Declared participation in any medical trials in the past 3 months
* Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants age 55 to 112 days
* Subject's parents/legal guardians provide written informed consent

Exclusion Criteria:

* Prematurely born subjects \< 37 weeks gestation
* Known or suspected disease of immune system
* Known or suspected hypersensitivity to any vaccine or vaccine component
Reclaiming Indigenous Food and Health

The overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among Native American participants.

The overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among Native American participants on the Wind River Indian Reservation (WRIR) in Wyoming.

Participants from the WRIR will be recruited to pilot a randomized control trial (RCT) with a delayed intervention to measure the impacts of consuming a diet that is 50% indigenous foods (based on participant total energy needs and recommended dietary pattern). Specific objectives of the pilot RCT will be to: (1) evaluate the feasibility of access, collection, and consumption of indigenous plants/animals, (2) define precisely what constitutes a "50% indigenous food diet" that will be supplied as the intervention in this trial, (3) quantify the time commitment and logistical challenges to access and collect indigenous foods, (4) evaluate the consumption of indigenous foods on health outcomes including waist circumference, body mass index, blood pressure, blood glucose control, and blood lipid levels, and (5) evaluate the impact of consuming indigenous foods on cultural identity.

The pilot RCT will primarily address objectives 4 and 5. In order to meet these specific objectives, the investigators will pilot a RCT with delayed intervention to provisionally assess health impacts of consuming a diet that is 50% indigenous foods for four weeks. Health outcomes assessed will include biometric measures of waist circumference, body mass index, blood pressure, hemoglobin A1C, total cholesterol with triglycerides; and survey measures of quality of life, cultural identification, and food security.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as living within the boundaries of WRIR (including the city of Riverton)
* self-identify as an enrolled member of the Eastern Shoshone or Shoshone Bannock tribe
* be interested in following a 50% traditional diet for 4 weeks
* 18 years of age or older

Exclusion Criteria:

- Diagnosed with any disorder that causes a compromised immune system (e.g. cancer such as leukemia, HIV/AIDS)
BRCA Founder OutReach (BFOR) Study

The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported age ≥ 25
* Self identify as having at least one of their four grandparents as Ashkenazi Jewish
* Has medical insurance
* Able to understand and read the English-language
* Zip code falls within the catchment areas of the phase of the study (e.g. New York City, Boston, Philadelphia, Los Angeles) accessible to a BFOR designated provider

Exclusion Criteria:

* Under age 25
* No Ashkenazi Jewish ancestry
* Does not have insurance
* Has previously had medical BRCA testing ordered by a health care provider