cyrilzakka/clinical-trials huggingface dataset:
Motivational Interview in Primiparous Pregnants With Low Belief in Normal Birth

This study aims to determine the effect of motivational interviews made with primiparous pregnant women with low belief in normal birth on medical and natural birth belief. This randomized controlled study was conducted in a randomized controlled manner with a total of 148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern Turkey (74 trials, 74 controls). In the study, a total of four sessions of motivational interviews were conducted with the primiparous pregnant women in the experimental group, one week apart. No intervention was applied to the women in the control group. Research data Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural and medical birth belief) Scale (BBS) were used. Descriptive statistics, Pearson's chi-square test, and dependent and independent t-test were used to analyze the data.


Eligibility Criteria:
Inclusion Criteria:

* Having a low level of belief and tendency towards normal birth according to the Normal Birth Belief Scale (between 24-56 points),
* Primiparous pregnant,
* According to the calculations made by USG of the pregnant women who do not know the last menstruation date or the last menstruation date, 24-36 days of pregnancy. in the week,
* Pregnant women who volunteered were included in the sample of the study.

Exclusion Criteria:

* Premature birth,
* Having any risk diagnosed during pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
* Contraindications for normal vaginal delivery
* Developing cesarean indication,
* Not completing MG sessions,
* Pregnant women with deficiencies or errors in any of the forms in which the data were obtained were excluded from the sample.
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fasted Conditions

Objective:

Primary objective of the present study was to assess the relative bioavailability of two formulations of Extended Release Alfuzosin 10 mg under Fasted conditions, in healthy adult male subjects after an oral administration with 7 days washout period.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

(\*)The volunteers were excluded from the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years. .
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

(\*)The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Effect of Sepsis Response Team in the Emergency Department

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour?

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour? The time from the patients arrive at the emergency department to an adequate antibiotic is given, before and after introduction of a sepsis response team, was registered.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected sepsis

Exclusion Criteria:

* Patients who was consider not to need antibiotics
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms

This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related cataract in the study eye
* Scheduled for cataract surgery and lens implant

Exclusion Criteria:

* Diagnosis of ocular surface disease or glaucoma
* Ocular surgery in the past 3 months
* Wearing a corneal contact lens in the study eye
Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)

In this phase II, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of OPERA® for treating anti-aromate inhibitors (AIs) induced arthralgia. The diagnosis of arthralgia will be based on the NCI-CTCAE v4.0 grade of ≥ 1 , A disorder characterized by a sensation of marked discomfort in a joint, mild pain (grade 1). Arthralgia will be assessed at the enrollment and every two months until the sixth month.

Aromatase Inhibitors (AIs) are recommended for the adjuvant treatment of hormone receptor positive breast cancers in the post-menopausal population. Compared with Tamoxifen, third generation aromatase inhibitors have been shown to significantly improve disease free survival (DFS), and include the steroidal inhibitor exemestane, and the nonsteroidal inhibitors, anastrozole and letrozole. Although the AIs are associated with fewer thromboembolic events and endometrial abnormalities than is tamoxifen, approximately 25% of postmenopausal women on AI report arthralgia, skeletal, and muscle pain. The multicentre double-blind placebo-controlled ma.17 trial by the National Cancer Institute of Canada Clinical Trials Group revealed marked increases in arthralgia (25% vs. 21%) and myalgia (15% vs. 12%) in patients on letrozole as compared with those on placebo. The Intergroup Exemestane Study shown a link between arthralgia and the ai exemestane (5.4% exemestane vs. 3.6% tamoxifen).The Arimidex, Tamoxifen Alone or in Combination (atac) trial, after 68 months' median follow-up, showed that the incidence of arthralgia was significantly higher in the anastrozole group than in the tamoxifen group \[1100 of 3092 (35.6%) vs. 911 of 3094 (29.4%) patients\]. Currently, evidences of drugs efficacy to reduce these side effects are sparse.OPERA® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-Lipoic acid (240mg), BS (40mg), MSM (200mg) and Bromelain (20mg) are combined together in a single hard-gelatin capsule. The aim of this prospective study is to determine the efficacy and safety of OPERA® supplementation in a series of patients affected by arthralgia during AI treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Karnofsky performance score≥70
* Indication for AI treatment in adjuvant setting for breast cancer
* Arthralgia with grade ≥0-1

Exclusion Criteria:

* Concomitant diseases, e.g. diabetes, renal insufficiency, alcohol abuse
* Concomitant rheumatological disease (Rheumatoid arthritis, Spondyloarthropathies, Psoriatic arthritis, etc.)
* Concomitant endocrinological disease (Acromegaly , Emocromatosis, etc)
* Any conditions that would complicate arthralgia assessment (e.g. Trauma, Glucocorticoid withdrawal, Hypertrophic osteoarthropathy, Osteoarthritis, Avascular necrosis, Gout, Systemic lupus erythematosus, Septic arthritis, etc.)
Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life

The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Female patients older than 18 years of age
* Clinical or laparoscopic diagnosis of endometriosis
* Having endometriosis related pain as leading symptom
* Decision taken by physician to prescribe Visanne
* Signed Informed Consent Form

Exclusion Criteria:

* Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a medication (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Effects of Adding Raisins to the American Diet on Fecal Microbiota Composition

Raisins contain a significant amount of dietary fiber and polyphenolic compounds that represent an important substrate for microbiota fermentation which generates potentially beneficial end products, such as short-chain fatty acids. The mammalian gut contains a phylogenetically as well as functionally diverse microbiota that contributes to host physiology. To date, little is known about how increased raisin intake affects human gut microbiota composition.

This research study will assess the effects of adding raisins to the diet of healthy adults on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function. The hypothesis is that by adding raisins to the diet this will result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be beneficial, as evaluated by an increase in butyrate producers and bacteria associated with anti-inflammatory properties.

The research study design is a 14 day international focus on increasing raising intake. Participants will be provided with a commercial raisin product for a 14 day period. Participants will consume 2 servings/day (84g of raisins). While participants will be told to substitute raisins for other diet ingredients, they will be free to choose what to substitute according to their preferences. Participants will keep daily food records and will be told that raisin consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day1), during (Day5-7) and at the end (Day 12-14) of the intervention using a stool collection kit (Sigma). Participants will complete a GI health questionnaire on a weekly basis to determine tolerance to increased raisin intake.

Eligibility Criteria:
Inclusion Criteria:

* Good Health
* No systemic antibiotics during the preceding two months
* No medication suppressing immune function
* Willingness to provide basic demographic as well as medical history data

Exclusion Criteria:

* Gastric Ulcers
* Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
* Chronic constipation/diarrhea
* Body Mass Index (BMI) \> 30
* Dietary restrictions that prevent legume intake
* Currently on any medication that can affect GI transit time
* Consumption of \>3 servings/week of raisins BEFORE study begins
Patient Specific Virtual Reality for Simulation of Spine Procedures: an Intelligent Image Segmentation, Registration and 3-dimensional Visualization in a Unified Virtual Reality Workflow for Image Guided Therapy, and Education - Physician Testing

The goal of this clinical trial is to learn if patient specific virtual reality (VR) simulations can be used for surgical orthopaedic education in resident and fellow physician populations.

This project will combine advanced 3d visualization, interaction, medical image segmentation, and registration to create and integrate a virtual reality (VR) model into surgical orthopaedic education. The work has 3 aspects,

1) creating a patient specific 3D model with high accuracy of anatomic structures using patient specific medical imaging in an automated fashion, 2) interacting with 3D models of the patients, allowing the surgical procedures to be performed in virtual reality (including the resection of tissues, and placement of implants), 3) integrating the VR simulator into the surgical education of orthopaedic residents and fellows in training. This platform will reduce the time and cost associated with use of patient specific data, ultimately enabling pre-operative planning, post-procedural assessment and surgical simulation of spine procedures. The technology will improve surgical training, and the options for pre-treatment planning that will lead to better patient care, more efficient use of operating room time, and better trained surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Any resident of fellow physician enrolled in the participating site's spine surgery training program.

Exclusion Criteria:

* None.
Therapeutic Processes in iCBT for SAD

The current study examines therapeutic processes during internet-based cognitive-behavioral therapy for social anxiety disorder. Participants will be randomized to either treatment or wait-list conditions. Participants in the wait-list condition will receive active treatment following the wait-list period.

Internet-based cognitive-behavioral therapy (iCBT) is an effective treatment for social anxiety disorder (SAD). However, little is known about the processes and mechanisms of change in this treatment. Compared to face to face (FTF) treatments, online interventions may operate through partially different mechanisms of change due to the text-based nature of the interaction and the reduced level of therapist involvement. The present randomized controlled trial will examine therapeutic processes during iCBT for SAD including the presence of sudden gains and their relationship to outcome, the relationship between anxiety and depressive symptoms along the course of treatment, changes in the therapeutic alliance and attrition from therapy. Moreover, we will compare iCBT for SAD with a wait-list control group and utilize weekly measurements of anxiety, depression, and SAD-related cognitions in both groups. This will facilitate comparison between temporal processes in both conditions and also shed light on processes occurring in wait-list conditions.

Eligibility Criteria:
Inclusion Criteria:

* Meeting DSM-5 criteria for social anxiety disorder.
* Fluency in Hebrew
* Access to internet

Exclusion Criteria:

* Substance use disorders
* Past or present psychosis
* High levels of suicidality
* Changes in pharmacological treatment 3 months or less prior to the start of the trial
* Participation in other psychotherapeutic treatments during the trial
Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine

Various field studies has found that the modified , bivalent, whole cell - based oral cholera vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in earlier clinical trials. However, the effectiveness of the vaccine in "real" life situation using the public health system is unknown. It is critical to follow up in the same population, where pilot introduction of OCV was introduced and evaluate vaccine proactive effectiveness at individual as well as at population level. The follow - up and determination of effectiveness of mass OCV vaccination was requested by State Government.

The overall goal of this study is to evaluate the protective effectiveness of one or two doses of modified, bivalent, killed whole cell based OCV, given at least 14 days apart, when delivered through community - based mass vaccination campaign using existing public health infrastructure in a high - risk population in Satyabadi block of Puri district, Orissa, India.

This study has following objectives

Primary objectives:

\* To evaluate the individual level protective effectiveness of one or two doses of OCV against culture confirmed cholera episodes, severe enough to seek a formal health care.

Secondary objectives:

* To evaluate population - level effectiveness (herd effects)of OCV delivered through a community based mass vaccination when the vaccine is delivered to more than half of population at risk.
* To determine inverse correlation between vaccine coverage and cholera incidence among diverse geographical clusters.

Eligibility Criteria:
Inclusion criteria for cases of the main case-control study are as follows:

* Giving verbal informed consent/assent, or in the case of minors, a parent or guardian give informed consent to participate in the study
* Living in the study area since the start of the mass vaccination
* Submitted a faecal specimen
* Whose residence could be located
* Whose stool specimens yield V. cholera O1 or O139
* Belonging to study population through census database

Exclusion criteria:

* Not giving verbal informed consent/assent, or in the case of minors, a parent or guardian does not give informed consent to participate in the study
* Not living in the study area since the start of the mass vaccination
* No faecal specimen
* Whose residence could not be located
* Whose stool specimens does not yield V. cholera O1 or O139
* Not belonging to study population through census database
Substance-focused SBI as a Complement to Internet-based Psychiatric Treatment: RCT

Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.

Method: This is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) and/or problematic drug use (DUDIT \> 1 for both men and women) are randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.

The hypothesis is that the group receiving the eScreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.

This study evaluated the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. The design was a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) and/or problematic drug use (DUDIT \> 1 for both men and women) were randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months.

The hypothesis was that the group receiving the eScreen intervention would reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level. The results have not yet been analyzed due to technical issues. However, qualitative interviews have been conducted with participants and our intention is to publish the qualitative results in tandem with the quantitative results available.

Eligibility Criteria:
Inclusion Criteria:

AUDIT \>7 for men and AUDIT \>5 for women, and/or DUDIT \>0

Exclusion Criteria:

DUDIT = 0 and AUDIT \<8 (men) or \<6 (women)
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017

This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.

This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.

Eligibility Criteria:
Inclusion Criteria:

* Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.

Exclusion Criteria:

* Anticipation of need for a major surgical procedure or radiation therapy during the study.
* Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure.
* Participants with clinically significant pleural or pericardial effusions.
* Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
* Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.