cyrilzakka/clinical-trials huggingface dataset:
Asthma and Indoor-air: Reducing Exposures

Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing asthma symptoms. One intervention group will have high efficiency filters or filtration systems installed in their central heating and air conditioning (HVAC) system. The second intervention group will have high efficiency portable air cleaners placed in the child's bedroom and in the main living area. Each participant will receive true air filtration for a year and a placebo for a year. During the placebo period a sham filter will be used that removes very little of the particles. Measures of health effects will include days of symptoms, unplanned utilization of the healthcare system for asthma-related illness, short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years of age
* Living in Fresno, San Bernardino or Riverside Counties.
* Physician diagnosed asthma, as stated by the participant's caregiver.
* In the last six months, the child must have had asthma symptoms at least twice a week for several weeks in a row.

Exclusion Criteria:

* Children living in homes where more than 2 cigarettes are smoked per week in the home.
* Children that spend 2 or more nights per week in another home.
* Children living in homes that are planning on moving in the next 2 years.
* Children living in homes that keep their windows open most of the time.
* Children living in homes that have existing high efficiency filtration.
Pharmacokinetic Profile of Rosemary Extract Supplement

This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged between 25 and 55 years
* Non-smoker
* Body Mass Index (BMI) between 20 and 30 kg/m2

Exclusion Criteria:

* Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
Biomechanical Analysis of Different Landing Manoevres

In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of different landing manoevres will be compared in a population of basketball and volleyball players.

In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of different landing manoevres will be compared in a population of basketball and volleyball players. General as well as more sport-specific jumps will be performed in this study.

Eligibility Criteria:
Inclusion Criteria:

* volleyball and basketball players
* male

Exclusion Criteria:

* history or surgery of the lower extremities
* history of fractures of the lower extremities
Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus

Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy

The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.

Eligibility Criteria:
Inclusion Criteria:

* Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

* Risk of aspiration
* History of esophageal surgery
* Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
* Known or predicted difficult airway.
An Exploratory Investigation of a Supplement to Promote Gut Health

Bovine colostrum is a dairy food and the first milk produced by the mother cow. Abundant research exists revealing the valuable health benefits it confers due to its unique nutritional properties., including benefits to gastrointestinal health, fitness, and overall well-being.This study aims to test a specific food-grade supplement, ARMRA Colostrum Immune Revival, over a 12-week trial to better understand the well-being, fitness, and gut benefits. This trial will use two groups, one that suffers from gastrointestinal complaints frequently and another that exercises at least three days a week.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 18-65 years of age.
* Self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) (GUT HEALTH GROUP ONLY)
* Must be physically active three or more days a week and willing to maintain their current activity level (PERFORMANCE GROUP ONLY)
* Must be willing to refrain from lifestyle changes affecting their gastrointestinal tract.
* Must be in good health with no significant chronic conditions.
* Following a stable, consistent diet regimen.
* Have a reliable way to measure their weight.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
* Has a lactose allergy or intolerance.
* Serious food allergies
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)

The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of moderate COPD.
2. Motivation for Pulmonary rehabilitation.

Exclusion Criteria:

1. Comorbidity contraindicating rehabilitation.
2. Participation in pulmonary rehabilitation within the last year.
3. Cognitive disorders limiting the ability to participate in physical training and education sessions.
Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology

Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.

However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.


Eligibility Criteria:
Inclusion Criteria:

* Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital

Exclusion Criteria:

* Term neonate \> 28 days
* Premature neonate \> 41 weeks of corrected gestational age
* Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
* Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.
Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

This is a prospective, observational study designed to look at ultrasound images of the joint at baseline and over time, and investigate whether there is a correlation between ultrasound images and progression of disease. The researchers wish also to see if ultrasound can be used as a tool to predict progression of Rheumatoid Arthritis in patients with early disease who have not taken biologics therapy. In addition, the researchers wish to investigate whether peripheral blood "biomarkers"can be identified that predict the progression of erosive disease in early rheumatoid arthritis, with the intention of testing the most promising biomarkers in future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 18 years or greater.
2. The subject has a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) with onset of symptomatology of less than 3 years.
3. The patient is seropositive for rheumatoid factor (IgM RF measured by agglutination assay) and / or anti-cyclic citrullinated peptides (measured by ELISA).
4. The subject has provided signed and dated written informed consent prior to admission to the study
5. The subject is able to understand and comply with protocol requirements, instructions and restrictions.

Exclusion Criteria:

1. Past or present disease, which as judged by the investigator, may affect both the subject's participation in the study or outcome of the study. These diseases include but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease.
2. Current or prior use of biologic drugs ( anti- tumour necrosis factor alpha drugs or rituximab)
3. As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the subject unfit for the study.
4. The subject's RA does not have a clearly recordable time of onset (within a 6 month period) as determined by either the notes or from the history taken from the patient by the physician responsible
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinically significant macular edema and diffuse macular edema

Exclusion Criteria:

* any history of focal photocoagulation
* any prior intra ocular injection
* history of glaucoma with high pressure
* history of ophthalmic surgery
* high rish PDR
* active PDR
Seroquel XR in the Long Term Treatment of Schizophrenia

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improves the relapse prevention in schizophrenic outpatients


Eligibility Criteria:
Inclusion Criteria:

* schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Exclusion Criteria:

* Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity
Thoracolumbar Burstfractures, Orthesis or No Orthesis

Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing.

Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. The investigators hypothesize that no treatment is superior over one other.

Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs.

Study population: Patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI\> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study.

Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance.

Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.

No extra information

Eligibility Criteria:
Inclusion Criteria:

* Th10-L4
* AO foundation type A3 or A4 type fractures
* Single level
* Kyphosis \< 35 ° at first analysis
* Neurologically intact
* Adequate trauma

Exclusion Criteria:

* Inadequate knowledge of the Dutch language
* Multitrauma, which asks for multidisciplinary treatment
* Inability to wear a brace due to overweight (BMI\> 35)
* Known osteoporosis
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura

This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.

During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.


Eligibility Criteria:
Inclusion Criteria:

- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13

Exclusion Criteria:

- None
INGEST I Pilot Study

INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture.

Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
3. Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
4. Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
5. Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
6. Ability to undergo periodic endoscopic follow-up.
7. Voluntary participation and provided written informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Contraindication to endoscopy, anesthesia or deep sedation.
3. Benign esophageal stricture due to extrinsic esophageal compression.
4. Currently required chest radiation therapy.
5. Malignant esophageal stricture.
6. Stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
7. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
8. Active erosive esophagitis.
9. Present esophageal ulceration, perforation, leak, fistula, or varices.
10. Concurrent gastric and/or duodenal obstruction.
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Severe coagulation disorders or current use of anticoagulant for comorbidities.
14. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
15. Received steroid injections into target stricture in the last 4 weeks
16. Intolerant to proton pump inhibitors.
17. Life expectancy of less than 12 months.
18. Unwilling or unable to comply with the follow-up study requirements.
19. Lacking capacity to provide informed consent.
20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, recent laparotomy, pharyngeal or cervical deformity, etc.
21. Currently participation in another pre-market drug or medical device clinical study.
Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth

The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women and infants
* Prior to 23 completed weeks of gestation
* Live in Colorado

Exclusion Criteria:

* Multiple gestation
* Preexisting

  * cancer
  * psychiatric disease
  * steroid-dependent asthma, or
  * diabetes
* Previous premature delivery prior to 25 weeks gestation or fetal demise
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
* Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer \[NSCLC\] staging system)
* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
* Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
* Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening

Exclusion Criteria:

* Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
* Has mixed small cell lung cancer
* Participants with large cell neuroendocrine carcinoma (LCNEC)
* The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease
* Known EGFR sensitizing mutations and/or ALK rearrangement

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract

Radical radiotherapy for head and neck squamous cell cancer (HNSCC) can be administered to primary disease with curative intent. Residual disease, recurrence or further tumours may subsequently occur in this irradiated field. It is unknown whether these cancers reflect primary resistance or represent the evolution of resistance on treatment.

Understanding this could allow stratification of patients to more effective primary treatments, such as transoral robotic surgery, or help tailor systemic therapies for these cancers in previously irradiated fields.

RECUT+ is an exploratory molecular analysis study to assess the selective impact of radiation therapy on HNSCC.

Participants will be recruited from the Royal Marsden Hospital (RMH), Chelsea, a tertiary referral H\&N cancer unit in London, UK, specialising in transoral robotic surgery.

Retrospective participants will be identified from previous Head and neck MDT lists at RMH.

Prospective participants will be screened for by the RECUT+ team during the weekly H\&N MDT meetings at the Royal Marsden Hospital (RMH).

Blood/saliva samples will be collected pre operatively (prospective participants) and post operatively (retrospective and prospective participants) for germline and circulating tumour DNA analysis.

Biopsy samples from the original cancer and resected specimens from the post radiotherapy residual/recurrent/new primary disease will undergo molecular analysis to assess for any selective impact of radiotherapy on these further tumours.


Eligibility Criteria:
Inclusion criteria

* Aged over 18
* Previous H\&N cancer treated with radiotherapy.
* Undergoing TORS as part of their management for residual, recurrent or new primary H\&N cancer.

Exclusion criteria

* Where TORS is used in a diagnostic setting only
* Nasopharyngeal and thyroid head and neck cancers
* Where no tissue specimens are available from the recurrent/residual/secondary tumour for the retrospective cohort