cyrilzakka/clinical-trials huggingface dataset:
Spacer Comparison In Adult Asthmatics

Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Eligibility Criteria:
Inclusion criteria:

* Non-smoking with a BMI of 19 - 30
* Diagnosed with mild or intermittent asthma and taking medication for it.

Exclusion criteria:

* Taking oral corticosteroids or inhaled fluticasone propionate
* Have certain medical conditions or are not otherwise healthy.
Psychological Assessment of Adults Seeking Orthodontic Treatment

Is their a association between the objective and subjective severity of a malocclusion, quality of life and self-esteem/personality (as modifier between objective/subjective severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare motivation and expectations and the objective and subjective severity of the malocclusion on the other hand.


Eligibility Criteria:
Inclusion Criteria:

* good health,
* thorough knowledge of the Dutch language

Exclusion Criteria:

* language
Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy

This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to PERT.

This is a multicenter, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed CF patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. Data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection.

This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research \& Development, LLC.

Eligibility Criteria:
Inclusion Criteria:

All Patients (PERT-exposed and unexposed controls) must meet the following criteria:

* Have a blood draw planned as part of their standard of care following enrollment into the study; and
* Provide informed consent/assent.

Patients in the PERT-Exposed Group must meet the following criteria:

* Have been diagnosed with CF; and
* Have received PERT for a minimum of 6 months.

Patients in the Unexposed Control Group must meet the following criteria:

* Be under medical management for chronic disease;
* Never received any PERT product; and
* Match an enrolled PERT-exposed patient based on age and region-of-residence.
* Have a blood draw planned to be performed within 180 days of the matched PERT-exposed patient blood draw.

Exclusion Criteria:

* Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine derived insulin. This exclusion does not apply to previous porcine-derived heparin exposure. ;
* Refuses blood collection; or
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults

Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting.

Aim 1: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (Low Luminance Questionnaire) and to determine whether such differences are associated with life space.

Aim 2: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (objective measures of visual function) and to determine whether such differences are associated with life space.

Eligibility Criteria:
Inclusion Criteria (Patients):

* Participants that are enrolled in the Early Detection of Glaucoma Progression using a Novel Individualized Approach (IRB-300000301) or in the African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the Lamina Cribrosa in Progression (IRB-161115004).

Exclusion Criteria (Patients):

* Not being enrolled in one of the following two NIH-funded studies: 1. African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the lamina cribrosa in progression (EY026574) or 2. Early detection of glaucoma progression using a novel individualized approach (EY025756)

Inclusion Criteria (Controls):

* No diagnosis of eye disease

Exclusion Criteria (Controls):

* Cognitive impairment that would preclude ability to take the tests
Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers

This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.

PRIMARY OBJECTIVES:

I. To assess patient/survivor, caregiver/family member, and provider decision-making needs.

II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.

OUTLINE:

Participants use decision aid and complete questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older
* Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
* Able to speak, read, and write English
* Pregnant patients are included

Exclusion Criteria:

--Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.

This is an open label intermediate-size patient population expanded access IND protocol.

Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances:

* refusal of transfusion
* lack of compatible red blood cells due to alloimmunity

All patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. If those measures are not successful and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Critically ill patients with hemoglobin \< 5 g/dL (or 6-7 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits
3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent
4. Blood is not an option due to:

   * refusal of transfusion
   * lack of compatible red blood cells

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis\*
3. Patients who are eligible for blood transfusions
4. Patients who are \> 80 years old\*
5. Pregnant
6. Lactating

   * on a case by case and quality of life determination
Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft

The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age
* Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present
* Maximum of two teeth can qualify per patient.
* The buccal plate must be ≥ 1mm in width with a 4-wall configuration.
* Cases requiring minimal sinus grafting (\<3mm)
* Bone grafting limited to the apical portion of the osteotomy site

Exclusion Criteria:

* Exclusion Criteria:
* Untreated periodontal disease, endodontic-periodontal disease and/or caries
* The buccal plate must be ≤ 3mm in width with a 4-wall configuration.
* Patients with uncontrolled or severe systemic disease (Diabetes)
* Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy)
* Current Smokers
* Subjects with extensive parafunctional habits (ie; bruxism)
* Subjects who demonstrate inadequate oral hygiene
Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome

In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.

Down syndrome (DS), the most common genetic cause of intellectual disability, can be associated with a wide range of developmental needs. Behavioral challenges are common, and can impact learning, overall achievement, relationships, inclusion in schools, and community integration.

The goal of this study is to determine whether JASPER (Joint Attention Symbolic Play Engagement and Regulation) can improve caregiver implementation of behavioral strategies, caregiver self-efficacy and confidence, and child development.

Participants will be randomized to receive either the JASPER intervention or a caregiver psychoeducational group. Participants in the JASPER intervention will receive 10 weekly virtual educational sessions utilizing JASPER therapy modules through 1:1 parent-child coaching sessions. Caregivers in the comparison group will receive 10 weekly modules containing a psychoeducational curriculum. The outcome measures will assess caregiver responsiveness, child joint engagement with caregiver, caregiver self-efficacy, and child behavior, language, and adaptive skills.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Trisomy 21
* Age 3-7 years
* Able to walk independently
* English speaking
* Caregiver able to complete either 1:1 virtual coaching sessions or psychoeducational behavioral curriculum

Exclusion Criteria:

* Mosaic Down syndrome
* Significant and uncorrected hearing and/or vision problems
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

The purpose of this study is to see how well patients tolerate the side effects of treatment with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used together are a useful way of treating cancer. We have studied these drugs and know the best doses of each when they are used alone. We do not yet know how well the drugs work with each other. This study will tell us the best doses of each drug when they are given over the same period of time.


Eligibility Criteria:
Inclusion Criteria:

* History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease.

Confirmation of diagnosis must be performed at MSKCC.

* Patient's liver metastases must be deemed unresectable and comprise \<70% of the liver parenchyma.
* A patient may have had prior chemotherapy or be previously untreated.
* Patient may not have received prior treatment with FUDR or \>2 doses of Oxaliplatin.
* KPS \> or = to 60%.
* WBC \> or = to 3,000 cells/mm3 and platelet count \> or = to 100,000 cells/mm3 within 14 days of registration.
* Creatinine \< or = to 1.5 mg/dl within 14 days of registration.
* Total serum bilirubin \< or = 2.0 mg/dl within 14 days of registration.

Exclusion Criteria:

* No active concurrent malignancies: except a patient's potentially resectable colorectal primary.
* Patient must not have obstruction of GI or GU tract.
* Patient must not have current, symptomatic peripheral sensory neuropathy.
* No prior radiation to liver.
* No active infection, ascites, or hepatic encephalopathy.
* Age ≥ 18 years.
* Female patients cannot be pregnant or lactating.
* Signed informed consent.
Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia

Descriptive prospective study to investigate the prevalence of COVID 19 during ambulant screening

The exact prevalence of COVID-19 is unknown. Due to the relatively high number of diagnosed, symptomatic infections despite a strict policy, we expect a high prevalence of COVID 19 throughout the entire population. The risk that an asymptomatic carrier who is admitted to the hospital for a (semi)urgent surgery, treatment of investigation transfers the virus to the hospital staff is very high, and vice versa. This risk is even higher during surgery, where intubation is necessary. Therefore we would like to pre-screen all patients ambulantly on the presence of COVID 19 since there is no consensus for screening at the moment. The golden standard is the SARS CoV-2 PCR on the nasopharyngeal sample together with a CT scan of the lungs. Patients in which a bloodsample is taken as standard of care procedure in this ambulant screening will be asked to give more blood for further investigation.

On top of this standard of care screening, we will perform a questionnaire at the pre-operative visit which evaluates the possible occurence of certain symptoms in the last 2 weeks. These symptoms are fever, anorexia, cough, diarrhea, sneezing, vomiting, dyspnea, headache, rhinorrhea, loss of smell, muscle pain, sputum, sore throat and fatigue. Patients were also asked if one of their housemates are affected by these symptoms. Furthermore, 2 weeks after surgery, patient will be contacted to phone in order to fill the same questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients \> 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital

Exclusion Criteria:

* Patients \< 18 years
* Adult patients who are unable the give informed consent
* Language barrier
Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the twelve-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)

Exclusion Criteria:

* Presence of orthodontic appliances.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
* History of alcohol and/or drug abuse.
* Self-reported pregnancy and/or lactating subjects
Role of Low Dose Injectable Progesterone in Triggering Ovulation

The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.

Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility.

Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis.

Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 35 years.
* Infertile women.
* Basal follicle-stimulating hormone (FSH) level \<10 mIU/ml.

Exclusion Criteria:

* Poor ovarian reserve.
* Immunological disease.
* Endometriosis.
* Uterine abnormality.
* Body mass index (BMI) \>30 kg/m2.
* Endometrial thickness \<8 or \>12 mm on the day of triggering.
Efficacy of AAC for Functional Communication

There is a considerable number children who are unable to speak, and our currently not being provided with any AAC options in their therapeutic facilities. The study aims to identify the current practice being employed with these children and then provide an AAC intervention for choice making with in group activities in the existing system, where the child is enrolled. Currently there is no indigenous evidence of AAC being employed effectively with these children. A pre- assessment will be carried out to establish the level of communication of the children. Intervention will be provided in a group for 6 weeks, three days a week, as these children already attend these groups.

The study is a novel approach to intervention in Pakistan. There are currently no such studies conducted on intervention using AAC use in Pakistan. The objective of the the study are as follows

1. To compare establish current practices with AAC for choice making in group activities.
2. To determine the frequency of choice making in structured group activities.

Hypothesis:

Null Hypothesis:

The use of augmentative alternative communication does not increase functional communication in group activities.

Alternative Hypothesis:

The use of augmentative alternative communication increases functional communication in group activities.

Study Setting: Step to Learn School

Assessment: An assessment will be carried out using the online Communication Matrix to establish baseline communication skills of all the children. The children will also be assessed informally for their current means of communication in existing group activity at baseline, mid level (3 weeks) and at the end of the study (6 weeks).

Intervention: Intervention will (3 days a week for 6 weeks) be provided through objects, picture cards placed on a choice board. The choice will be given for Rhymes, Individual Rhymes \& Sensory objects. Auditory, visual and tactile prompts will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Children with special needs
* Children not currently using any AAC

Exclusion Criteria:

* Children with any co-morbid conditions.