cyrilzakka/clinical-trials huggingface dataset:
Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial

The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the study participants will receive Vitamin D in supplement form. Pregnant women will be individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till the time of delivery.A blood sample will also be collected from the participant at the time of recruitment /before the starting of the supplementation for the assessment of Calcium, Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D level to assess vitamin D status will be done after completion of the supplementation phase at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan University laboratory

The investigators hypothesize that Pakistani mothers as darkly pigmented, will require substantially higher oral supplementation with vitamin D to replenish the micronutrient stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D deficiency. The investigators expect that if vitamin D is supplemented to pregnant women, their newborn infants would inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double blinded trial, study participants divided into three groups which will receive Vitamin D supplementation in 400, 2000 and 4000 International Units. The group which will receive 400 IUs will be treated as control group.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 15 - 45 years
* Less than 16 weeks pregnant from Last menstrual period.
* Agree to take part in this study, will be enrolled.

Exclusion Criteria:

* Pregnant women with pre existing type 1 or type II diabetes,
* Pregnant women with pre existing hypertension
* Women with multiple fetuses, babies (twins, triplets)
* Women with fetal anomaly in scan
* Refuse to participate in the study
Cross Therapy Registry - Oedema - EU (CTR-Oedema-EU)

The geko™ Cross Therapy Registry - Oedema - EU (gekoTM CTR - Oedema- EU) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

The geko™ device has a wide range of clinical applications including the post- operative management of oedema.

Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during follow-up of up to twelve months.

As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.

The geko™ Cross Therapy Registry - Oedema -EU (gekoTM CTR - Oedema - EU) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and able to provide written informed consent.
* Intact healthy skin at the site of gekoTM device application.
* Subjects receiving gekoTM therapy as part of their standard care for oedema reduction.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Use of any concurrent neuro-modulation device.
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
Prospective and Retrospective Breast Cancer Database

In order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. All data are from patients treated in Toulouse Centre.

The scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Histologically confirmed breast cancer of any stage
* Affiliated to a social security system in france
* Who signed the informed consent

Exclusion Criteria:

* Any psychiatric or medical condition that would make the patient unable to give a signed informed consent
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

To establish prospective cohort of healthy population and corresponding serum sample bank in Sichuan province to provide platform for exploring early diagnosis and screening strategy of gastric cancer by a prospective cohort study.

H. pylori was one of the most important carcinogenic factor for gastric cancer and play a crucial role in inducing gastritis, atrophy and canceration. Chronic atrophic gastritis (CAG) was a common precancerous disease, people with CAG become high-risk population and need regular follow-up. However, study about occurrence risk prediction for gastric cancer when H. pylori infection concurrence with CAG was still spare. In especial, there was still no population screening program based on serology. The relative clinical epidemiology for providing evidence for China gastric cancer screening program was very rare.

This study aim to evaluate gastric cancer occurrence risk and diagnostic value of people combined with H. pylori infection and CAG by Serological methods in Sichuan province China. We also project to design optimized screening program suitable for people in sichuan province China.

Eligibility Criteria:
Inclusion Criteria:

1. Inhabitant in Sichuan province in China (length of residence \> 10 years);
2. Complete physical examination in our hospital, the outcomes was asymptomatic and cancer free healthy individuals;
3. Age between 20 and 70;
4. With normal cognitive and communication ability;
5. Without gastroscopy during recruitment, physical examination item including gastroscopy enrolled in prospective cohort study;
6. Wiling to accept 1-2 times routine physical examination in our hospital;
7. Agree to accept the follow-up of our project group;

Exclusion Criteria:

1. With history of malignant tumor;
2. Refuse to donate blood specimen;
3. With serious comorbidity and/or finite life (less than 5 years);
4. Request to retreat from this study;
The Effect of a Coloring Prompt on Health Engagement

The goal of this project is to determine whether prompting the recipient of a health reminder mailing to ask his or her 4-9 year-old child to color on the reminder could increase engagement with the targeted health behavior

The investigators will randomly assign some individuals with 4-9 year old children to receive colorful reminders to engage in a given health behavior. Others will receive identical reminders along with a prompt to share the reminder sheet with their child so it can be turned into a piece of art. The investigators are interested in whether the coloring prompt will lead the reminder to stay in the home for longer, be placed on the refrigerator, etc. and thus result in an increase in compliance with the recommended health behavior.

Eligibility Criteria:
Inclusion Criteria:

* Indications according to Spring 2011 CDC criteria for a Pap smear
* Indications according to Spring 2011 CDC criteria for a blood pressure check
* Indications according to Spring 2011 CDC criteria for a cholesterol test
* Indications according to Spring 2011 CDC criteria for a fasting plasma glucose test
* Employee at partner corporation that implemented the study
Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge

A quasi-experimental study was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous antibiotics at hospital discharge with and without ID consultation.

The pre-intervention period was started from November 1, 2015 to April 30, 2016 (6-month period), in which the intravenous antibiotics at hospital discharge were prescribed by the primary care team. The post-intervention period was started from May 1, 2016 to February 28, 2017 (10-month period), in which the intravenous antibiotics at hospital discharge were reviewed and intervened by ID team.

The appropriateness of intravenous antibiotics was assessed separately by the ID fellow and ID specialist. If disagreement occurred, the feedback to the ID fellow was performed and the decision by ID specialist was used in the final analysis of appropriateness.

In post-intervention period, ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics

Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.

Eligibility Criteria:
Inclusion Criteria:

All adult patients who met the following criteria were consecutively enrolled;

1. age≥ 15 years old and
2. had infections at any sites and received intravenous antibiotics.

Exclusion Criteria:

- They were evaluated by infectious diseases specialist for appropriate antibiotics during admission
Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-59 months of age (not yet reached their 5th birthday)
* Parent or guardian available by telephone
* Available for illness visits at clinic or at home during the influenza surveillance period
* Written informed consent (and Health Insurance Portability and Accountability Act \[HIPAA\] authorization for U.S. Participants) obtained from the participant's parent or legal guardian and
* Ability of the parent/guardian to understand and comply with the requirements of the protocol

Exclusion Criteria:

* History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
* History of hypersensitivity to gentamicin
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
* History of Guillain-Barre syndrome
* Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
* Acute febrile (\>100.0 degrees F or \>37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
* Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
* Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
* Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
* Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
* Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
* Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
* Close contact who is severely immunocompromised (e.g., transplant recipient)
* Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
* Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
Topical Antifungal Treatment for Tinea Pedis

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.


Eligibility Criteria:
Inclusion Criteria:

* Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

* Pregnancy and allergies
In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon

During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.


Eligibility Criteria:
Inclusion Criteria:

* Regular diet with 3 meals a day (minimal 5 times a week)
* BMI between 18.5 and 27 kg/m2

Exclusion Criteria:

* Calorie restricted diet or other special diet during the study or during the last month prior to the study
* Antibiotics in the month prior to the study
* Former surgeries on the gastrointestinal tract, with the exception of an appendectomy
* use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics)
* Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance
* Pregnancy, pregnancy desire or breastfeeding
* Diabetes (type 1 and 2)
* Blood donation in the past 3 months prior to the study
* Abnormal hemoglobin (Hb) levels in blood, men must have a Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL
* Participation in studies in the past year in which radiation was used.
A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0003)

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1839100 in healthy male subjects following oral administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of trial medication until 90 days after end of trial medication:

  * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
  * Vasectomized (vasectomy at least 1 year prior to enrolment)
  * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Spirometric Detection of Esophageal Intubation

In endotracheal intubation, it is essential that the trachea is intubated and not the esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are available in the operating theatre are not appropriate for out-of-hospital situations because of several reasons. Moreover, these methods mostly take some time to provide the desired information and don't have optimal specificity and sensitivity. In order to allow fast diagnosis of this potentially fatal complication, we have developed a fully-automatic detection device to diagnose endotracheal tube malpositioning within 2 seconds.

A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).

A new stand-alone device with integrated sensors and microprocessor was developed that gives immediate diagnosis, and stores data for subsequent research purpose. This device will be evaluated in perioperative situations to demonstrate the high sensitivity and specificity in patients in a clinical setting.

The fundamental algorithm for waveform analysis is unchanged, but an additional detection algorithm is incorporated for improved detection of ventilation efforts. In addition, sensors are integrated, automatic feedback electronics are improved, and the device is made more user friendly to be appropriate for out-of-hospital situations in demanding environments.

In addition, waveforms will be recorded for later analysis and evaluation of the diagnostic value of a thoracic push ( a gentle push on the sternum) to detect tube position.

Eligibility Criteria:
Inclusion Criteria:

* General anesthesia with endotracheal intubation required for the procedure
* Age: 18 years and older
* Total intravenous anesthesia with propofol (in order ro guarantee adequate hypnosis during the procedure)

Exclusion Criteria:

* Oesophageal pathology
* Patients at risk for desaturation (SpO2 \< 95%) if 20 seconds of apnoea is induced after adequate preoxygenation
White Tea for Prevention of Chemotherapy Induced Mucositis

The aim of this study is to determine the effectiveness of mouthwash with white tea in the prevention of paclitaxel induced oral mucositis in women with breast cancer.

Oral mucositis is a common side effect from paclitaxel treatment. It can be very painful and compromise nutrition and oral hygiene, and it may increase the risk of infection. Although oral mucositis is a common side effect to chemotherapy, no available treatment is yet available that can effectively prevent or treat oral mucositis.

Based on the knowledge that white tea has anti-inflammatory, anti-oxidant and anti-microbial effect, the current study aims to assess the effect of mouth wash with white tea on paclitaxel induced oral mucositis in women with breast cancer.

This study is a phase II randomized controlled trial in which eligible patients will be allocated to a control group (CG) and a study group (SG). The CG will use salt water with soda for mouthwash eight to ten times a day and the SG will use white tea for mouthwash five to six times a day.

Eligibility Criteria:
Inclusion Criteria:

* Woman with breast cancer
* Planned neoadjuvant or adjuvant paclitaxel treatment
* Age ≥ 18 years
* Understand and speak Danish
* Written and orally informed consent

Exclusion Criteria:

- Palliative treatment with paclitaxel
Reducing Radioisotope Dose: the Half-Dose CZT Study

This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.

The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera.

The proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study
* suspected or known coronary artery disease
* written informed consent

Exclusion Criteria:

* Evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal
* Participation in another investigational study within the preceding month
* Pregnant and/or breast-feeding female
* ECG evidence of left bundle branch block or paced rhythm
* Evidence of non-ischemic cardiomyopathy
* Presence of hypertrophic cardiomyopathy and/or severe valvular heart disease
* Severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure)
* Known allergy to technetium-99m
* Potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate \< 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.
Genetic Study of Amyotrophic Lateral Sclerosis in Norway

The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.

After being informed about the study and potential risks, all patients giving written informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn. Blood samples, questionnaires, clinical information and signed consent is send to Department of Medical Genetics, Telemark Hospital Trust were the genetic analysis is performed successively throughout the recruitment period. Patients can choose to have their genetic results returned in a diagnostic setting.

Eligibility Criteria:
Inclusion Criteria:

* Probable or definite ALS
* Eligible to consent

Exclusion Criteria:

- not competent to give consent