cyrilzakka/clinical-trials huggingface dataset:
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Eligibility criteria:

Age 6 - 16 yrs

* IgE-mediated milk allergy
* and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms

Outcome measures:

* number of patients with successful desensitization (195 - 200 ml milk per day)
* number of patients with adverse events

Eligibility Criteria:
Inclusion Criteria:

* IgE-mediated milk allergy
* An immediately positive challenge test result to milk prior to inclusion

Exclusion Criteria:

* Not willing to participate
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication

This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).

Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.


Eligibility Criteria:
Key Inclusion Criteria:

* Pregnant women
* Part of the prospective arm of the APR Target Group Inclusion Criteria
* HIV-1 Negative
* Choosing to remain on FTC/TDF for PrEP during pregnancy or,
* Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
* HIV-1 Positive
* On antiretroviral therapy

Key Exclusion Criteria:

* This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gabapentin's Effects on Insomnia in Patients With Recent Concussion

In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia.


Eligibility Criteria:
Inclusion Criteria:

1. Head trauma causing concussion with either no loss of consciousness (LOC) or LOC \< 30 minutes within previous 2 weeks.
2. ISS score at Baseline of \> 14.
3. PCSS score at Baseline \> 5.
4. If brain imaging has been checked, there was no intracerebral hemorrhage noted.
5. Glasgow Coma Scale score of 15 at Baseline.
6. Age of at least 14 years old.
7. Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin.
8. Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks.

Exclusion Criteria:
Preventive Health Practices in Women

The purpose of this study is to evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice.

Increasingly, gender differences in manifestation of cardiovascular disease (CVD) and myocardial infarction (MI) are being reported. Gender specific presentations of MI in particular have contributed to underdiagnosis of cardiac events in women. Furthermore, previous studies from the 2002 Behavioral Risk Factors Screening Surveillance demonstrated decreased compliance with standard cardiovascular health practices in women compared to men. We seek to validate these findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.

Eligibility Criteria:
Inclusion Criteria:

* Women attending screening mammography and gynecology visit.

Exclusion Criteria:

* Patient refusal to participate (assessed by non-submission of the completed survey).
Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis

This is an interventional study which aims at assessing the effects of a digital patient journey solution in patients undergoing elective hip and knee arthroplasty due to primary osteoarthritis.

Traditionally, pre- and postoperative education has been provided face-to-face by paper-based methods for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Digital patient journey solution has potential to enhance adherence to preoperative preparation and postoperative rehabilitation, and further improve patient experience, while reducing potential adverse events.

The purpose of this study is to assess a digital patient journey solution developed for patients undergoing elective hip and knee arthroplasty. The digital solution aims to support patient's preparation to and recovery from a hip and knee arthroplasty through provision of timely information and support related to preoperative preparation and postoperative rehabilitation. The information on the application is aligned with the patient's individual needs and requirements, and contains exercises to be completed daily for the duration of the program.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing primary elective total hip or knee arthroplasty
* Diagnosis of primary osteoarthritis of hip or knee (M16.0, M16.1, M17.0, M17.1)
* Ability to speak, read and understand Finnish
* Access to a web-based device

Exclusion Criteria:

* Undergoing a total hip or knee arthroplasty revision
* A bilateral total hip or knee arthroplasty
* Total hip or knee arthroplasty following a rheumatoid arthritis
* Inability to walk with use of walking aids
* Unable to see or hear that impede the use of the digital patient journey solution
Pilot Study of Coil Arrays in Patients With Advanced Solid Tumor Malignancies

This is a single center pilot study testing the use of novel coil arrays with MR liver imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring \> 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly designed coil array, with the use of gadolinium contrast. Patients with liver tumors will have the option of undergoing a second MR liver scan during the course of subsequent systemic therapy.


Eligibility Criteria:
Inclusion Criteria (Part B only - Patients with advanced solid tumor):

* Advanced solid tumor malignancy and the presence of at least one liver metastasis measuring \> 1.5 cm in longest diameter in axial dimension on standard anatomic imaging

Exclusion Criteria (Part B only):

* Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies

Exclusion Criteria (Part A \[Healthy Volunteers\] and Part B):

* Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-Unsafe surgical implants or shrapnel)
Steroid Panel for One-step Diagnosis of Adrenal Diseases

The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Using mass spectrometry analysis based on a multisteroid panel, serum, urine, saliva, and hair samples of the patients will be analyzed. The diagnostic yield of each and combination of steroids will be evaluated.

Adrenal diseases consist of heterogenous diseases. To differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. In this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel.

About 400 patients with adrenal diseases including non-functioning adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Serum, hair, saliva, and urine samples of the patients will be analyzed using mass spectrometry. Each and combination of multisteroid will be evaluated for diagnosing adrenal diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with adrenal diseases

Exclusion Criteria:

* Taking medications that can affect steroid metabolism
* Major depression, chronic alcoholism
* Suspected cancer metastasis to adrenal glands
* Other acute stress conditions
Lifestyle Modification Program for Patients With Chronic Pain Conditions

In this observational study the effects of a Lifestyle Modification Program - offered as a semi-residential day care clinic - on pain, disability, quality of life and satisfaction with life will be investigated. Furthermore the influence of mindfulness, acceptance and coping, and acquired changes in lifestyle behaviors on the outcome after the program will be evaluated.

Effects will be measured after completion of the program (3 months), and at 6 and 12 months follow up after start of the program, i.e. each outcome measure will be taken 4 times within 12 months.

see above

Eligibility Criteria:
Inclusion Criteria:

* 18-78
* diagnosed with any chronic pain condition
* physical and mental ability to participate in the program and the study
* written informed consent

Exclusion Criteria:

* participation in any other clinical study focusing on psychological or behavioral intervention
Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study

Heart failure (HF) is a common and progressive condition associated with significant morbidity and mortality. Only 25-35% of patients survive 5 years after diagnosis.Sleep disorders are frequently found in this population with up to 94% of patients complaining of sleep disorders. Of these, insomnia and sleep disorders are the most common. The frequency of restless legs syndrome (RLS) varies between 4 and 40% depending on the studies. Patients with HF frequently experience poor sleep quality which is associated with deterioration in quality of life, alertness, and mood.

Few studies have examined the prognostic impact of sleep disturbances in this population. A greater morbidity and mortality is observed in the event of poor quality sleep or in the presence of sleep breathing disorders .

The investigators therefore propose to evaluate the sleep disorders of patients with HF by self-administered questionnaires, hypothesizing that complaints of poor sleep are linked to a poorer cardiovascular prognosis.


Eligibility Criteria:
Inclusion criteria:

- heart failure according to the 2016 criteria of the European Society of Cardiology.

Exclusion criteria:

- age less than 30 years
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea

The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 30 to 70 years of age
* The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)
* High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L

Exclusion Criteria:

* The presence of severe rosacea as noted by the investigator global assessment.
* Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
* Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment
* Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.
* Those who are unwilling to keep their facial regimen the same throughout the study.
* Individuals who have been on an oral antibiotic within the previous one month.
* Individuals who are pregnant or breastfeeding.
* Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
* Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
* Use of isotretinoin within the three months prior to enrollment.
* Individuals on finasteride or dutasteride
* Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

The aim of this study is to

Determine whether cerclage with vaginal progesterone will:

1. Reduce the overall spontaneous preterm birth rate.
2. Prolong pregnancy latency.
3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening.

Research question:

Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening.

Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.

A randomized controlled trial The study will be done in Ain Shams University Hospital including women attending antenatal care clinic in Ain Shams University Hospital.

All patients entering the trial will be counselled and will sign a written consent explaining the details of the trial. All the patients included in this study will undergo routine Fetal anomaly scan at 18-24 weeks.Patients with cervical length \< 20 mm in routine anomaly scan will :

1. Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be continued with vaginal progesterone until 37 completed weeks or until they develop preterm rupture of membrane or preterm delivery).
2. Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with progressive shortening of cervical length less than 10 mm during routine follow up, will have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal suppositories) alone, or having cervical cerclage placed in addition to daily vaginal progesterone.

In cerclage group: all patients will sign a written consent for approval of cervical cerclage.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged: 20-38 years old.
2. Single living fetus.
3. The patient does not have history of preterm labor (before 37 weeks of gestation)
4. No history of cervical or uterine anomalies.

Exclusion Criteria:

1. Congenital anomalies in the fetus discovered during the follow up.
2. History of spontaneous preterm births.
3. Evidence of imminent delivery, or uterine contractions.
4. Evidence of rupture of membranes, or intra amniotic infection.
5. Intra uterine fetal death.
6. Uterine or cervical anomalies.
An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal

There is a critical need for safe and effective antiretroviral treatment (ART) regimens for HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2 million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is frequent. Although an increasing body of evidence supports the potential utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to assess their effectiveness and they are not routinely available in resource-limited settings. These limitations present major challenges to HIV-2 treatment, particularly in the areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA \>250 copies/ml) participating in the 48 week trial of STRIBILD


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years old
* HIV-2 Infection (confirmed by DetermineTM \& Immunocomb II)
* ARV-naïve
* CD4 count \< 750 cells/mm3 and/or WHO Stage 3 or 4 disease
* Anticipate residing in Dakar area for duration of study

Exclusion Criteria:

* Pregnancy or Breast feeding
* HIV-1 or HIV-1/HIV-2 dual infection
* Known allergy or contraindication to Elvitegravir, Cobicistat, Emtricitabine, or Tenofovir DF
* Active Tuberculosis (STRIBILD contraindicated with rifampin)
Fat Distribution in Healthy Early Postmenopausal Women

The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy early postmenopausal women
* BMI between 25 and 30

Exclusion Criteria:

* Contra-indication(s) for hormone treatment
* Metabolic diseases
* Concomitant medication with influence on lipid metabolism
Effects of an Adapted Ski/Snowboarding Program on Quality of Life in Children With Physical Disabilities

This study is assessing quality of life in children with a physical disability who participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where children with physical disabilities are able to participate in more organized sports and active programs with the use of adaptive equipment. This study would assess a child's self reported and parent perceived quality of life before and after child participation in HSP for the winter season. The investigators aim to determine the level of child and parent happiness and satisfaction in specific quality of life aspects including: physical activities and health, feelings, moods, self perception, home life, friends, school, learning and bullying. The investigators believe that children with any physical disability will have a more satisfactory reported quality of life after participating in HSP for one or many years.

The purpose of this proposed research is to quantify the impact of participation in an adaptive ski/snowboarding program on parent perceived and child self-reported health related quality of life. To this effect, the study will assess children's self-perception of psychological, emotional, physical health of participants as well as their parents perception of the same, through the use of a validated self reported quality of life questionnaire, KIDSCREEN-52, before and after participating in an adaptive ski/snowboarding program every year.

Primary Aims:

1. To determine the level of subject and parent satisfaction and happiness, through a composite of 10 aspects in a quality of life questionnaire, following participation in the Children's Hospital Colorado Hospital Sports Program (HSP) for one winter season.
2. To determine the long-term impact of repeated participation in an adapted ski/snowboarding program through a composite of 10 aspects in a quality of life questionnaire, following participation in the Children's Hospital Colorado Hospital Sports Program (HSP) for consistent winter seasons.

Eligibility Criteria:
Inclusion Criteria:

* Physical disability
* Participant of HSP program

Exclusion Criteria:

* Completed parent and child KIDSCREEN questionnaires are not received before the subject's first day of skiing or snowboarding with the program
* Completed parent and child KIDSCREEN questionnaires are not received within 3 months after subject's completed participation with the program for that winter season
Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.

the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.

High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.

Eligibility Criteria:
Inclusion Criteria:

* primary AML（except APL patients）;
* ECOG PS:0-2

Exclusion Criteria:

* AML patient who has already received induction treatment, no matter what the outcome is;
* Treatment-related AML;
* Active cancer patients who's condition need to be treated;
* The one with serious infectious diseases（eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis）
* Active heart disease.
European Sickle Cell Disease Cohort - Hydroxyurea

In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
* With symptomatic sickle cell syndrome
* Treated with Siklos®
* Having been informed of the study by the initiating physician and consenting to participate to the cohort.