cyrilzakka/clinical-trials huggingface dataset:
A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo. Participants will be screened for eligibility, and will begin attempts at spontaneous conception. Following randomization and initiation of study drug treatment, participants will visit the study site at specified intervals throughout the study for assessments and blood work.

All participants will be monitored for adverse events. All participants who have received at least one dose of study drug will be followed for safety for a minimum of 4 weeks following the last dose of study drug. After delivery, pregnancy outcome information will be obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal female 18-37 years of age at consent, trying to conceive
2. Documented history of unexplained recurrent pregnancy loss
3. Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
4. Body mass index (BMI) of 19-35 kg/m2 at consent

Exclusion Criteria:

1. Greater than 5 weeks of gestation when presenting for randomisation.
2. Known karyotype abnormalities in either the participant or her current male partner
3. Uncorrected clinically significant intrauterine abnormalities
4. Abnormal vaginal bleeding of unknown cause
5. Current diagnosis of infertility in either the participant or her current male partner
6. Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
7. Any uncontrolled clinically significant medical condition
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food

Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. The aim of this study is to compare the reproducibility of different commercial extracts and raw food in patients with convincing history of acute allergic symptoms related to food .


Eligibility Criteria:
Inclusion Criteria:

* Suspected immediate allergic reaction to food

Exclusion Criteria:none
Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base

This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects (18-65 years of age).
* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
* FEV1 ≥ 80% of predicted.
* Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
* Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
* Written informed consent

Exclusion Criteria:

* Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
* History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
* History of cystic fibrosis, bronchiectasis or other respiratory diseases.
* History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
* Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
* Known intolerance or hypersensitivity to any component of the albuterol MDI.
Behavioral Economics Incentives for Health Management

Incentives are increasingly being used to motivate health behavior in medical studies. Small cash payments conditional on certain health and welfare promoting behaviors have shown efficacy in both real world and experimental settings. Furthermore, in incentive studies, behavioral economics has been shown to amplify behavior change beyond what is possible with simple cash payments, but little is known about how varying incentive payment design may impact health behavior. The goal of the present study is to evaluate a new incentive payment instrument, lottery insurance, to determine its impact on adherence to the target health behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a safety-net medical clinic.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 64 years of age
* BMI between 25-40
* Receiving care in QueensCare Family Clinics

Exclusion Criteria:

* Failure to obtain exercise clearance from physician
Inflammation and Vascular Function in Atherosclerosis

The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.

To test the hypothesis that inhibition of I \[kappa\] B kinase \[beta\] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking adult subjects with known atherosclerosis

Exclusion Criteria:

* Uncontrolled hypertension (\> 140/90 mmHg)
* Untreated hypercholesterolemia (LDL \> 160 mg/dL)
* Diabetes mellitus
* Alanine Aminotransferase \> 150
* Creatinine \> 1.4 mg/dL
* Concommitant use of warfarin
Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma

Non-medullary thyroid carcinoma has a good prognosis in most patients. However, a small subset of patients nevertheless develop metastatic or locally advanced and unresectable disease which in some cases also becomes radioiodine refractory. In these patients treatment options are very limited. Earlier cell line and animal studies have shown that digoxin can reinduce radioiodine uptake in non-medullary thyroid cancer. This study serves as a proof of principle study to assess the possibility of digoxin to reinduce radioiodine uptake in adult humans with metastatic or locally advanced non-medullary radioiodine refractory thyroid carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Non-medullary thyroid carcinoma
* Having undergone total thyroidectomy and at least 1 treatment with \[131\]sodium iodine (NaI)
* Presence of local or metastatic disease, radiologically proven. A minimum of 1 target lesion (at least 1cm for soft tissue and 1.5cm for lymph nodes) must be present.
* Radioiodine refractory disease; at least one lesion without therapeutic relevant uptake at previous post-therapeutic scintigraphy and/or negative diagnostic \[123\]NaI-scan.
* The target lesion must not be eligible for local treatments.
* Hematologic lab values should be at least: absolute neutrophil count \>1.4x10\^9/liter, hemoglobin\>5.5mmol/liter, thrombocytes \>99x10\^9/liter

Exclusion Criteria:

* Creatinine clearance \<50ml/min and/or active kidney disease
* Cardiac arrhythmias
* Electrolyte disorder
* Concomitant drugs that interfere with digoxin metabolism such as P-glycoprotein inductors or inducers, including but not limited to penicillamine, sulfasalazin, tipranavir, amiodarona, diltiazem, itraconazole, ketoconazole, kinidin, lapatinib, propafenon, vemurafenib, verapamil, azithromycin, clarithromycin, erythromycin, roxithromycin, chloroquin, ciclosporin, anti hepatitis C drugs, anti-HIV drugs, hydroxychloroquine.
* Pregnancy, lactating or breast-feeding women.
* Having undergone a procedure with iodine contrast agent within the last 3 months.
* Prior therapy with radioactive iodine \<6 months prior to participation.
* External beam radiation therapy \<4 weeks prior to participation.
* Having undergone chemotherapy or targeted therapy \<4 weeks prior to participation.
* Eastern Cooperative Oncology Group (ECOG) score \>2.
* Use of other investigational drugs within 4 weeks preceding the first dose of digoxin treatment.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to digoxin.
* Uncontrolled intercurrent illness that would limit compliance with the study requirements.
* Unwillingness or inability to comply with study and follow-up procedures.
* Other active malignancies other than basal cell carcinoma. Malignancies that have been in complete remission over 2 years are not considered active malignancies.
* Rapidly progressive disease in which urgent start with systemic therapy is required.
A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.

The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of \>= 50% stenosis and reference vessel of \>= 4.0 to \<= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.

It is anticipated that the total length of time required to complete the study will be 46 months.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis \>=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
2. The reference vessel renal artery must be \>= 4mm and \<= 8 mm by visual estimate.
3. The patient must have a baseline serum creatinine of \<= 5.0 mg/dl.

Exclusion Criteria:

1. Total occlusion of the renal artery.
2. Lesions which would require more than 2 stents.
3. Lesions which are in arteries to transplanted or bypassed kidneys.
4. Abdominal aortic aneurysm \> 4.0 cm in diameter.
5. Patients with ASA classification \>=4.
A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients

This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* chronic hepatitis C, genotype 1.

Exclusion Criteria:

* decompensated liver disease, or impaired liver function;
* presence or history of non-hepatitis C chronic liver disease;
* HBsAg or HIV infection;
* history of cancer within 5 years, other than localized or in situ cancer of the skin.
Pilates Method in Helicopter Pilots With Low Back Pain

The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.

Methods: This is a randomized controlled trial composed by Brazilian Air Force helicopter instructors. The volunteers will be submitted to an initial evaluation composed by painful sensation, analyzed through the Numerical Pain Scale, disability associated with low back pain, using the Roland Morris Disability Questionnaire, and back muscle fatigue, through the Ito test. The pilots will be randomly assigned to the Exercise Group (exercise program based on the Pilates method, twice a week for 12 weeks) and Control Group (no intervention). After the sixth and 12th week of the beginning of the intervention program a new evaluation will be carried out, identical to the initial one.

Eligibility Criteria:
Inclusion Criteria:

* Brazilian Air Force helicopter instructors - Natal Air Base;
* Nonspecific low back pain for more than 3 months with a score of 2 or more at Numerical Pain Rating Scale.

Exclusion Criteria:

* Be undergoing physiotherapeutic treatment during the study period;
* Corticosteroids treatment in the last two weeks;
* Anti-inflammatory treatment in the previous 72 hours;
* Have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.
A Focused Registry on Anterior Cervical Interbody Spacer ACIS

Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
* Degenerative cervical disc disease C3 through Th1 or
* Ruptured and herniated discs C3 through Th1
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the registry according to the registry plan (RP)
* Signed and dated IRB / EC-approved written informed consent

Exclusion Criteria:

* Spinal tumor
* Osteoporosis
* Cervical trauma and instability
* Any not medically managed severe systemic disease (ie. infection)
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry

Intraoperative exclusion criteria:

* Intraoperative decision to use implants other than the device under investigation
Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?

Stereotactic body radiation therapy, or SBRT, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. It uses fewer treatments of higher doses compared to standard radiation therapy.

This study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. The usual approach is defined as care most people get for advanced head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary
* Stages T0-T4/N0-N3
* Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
* Geriatric 8 score \<14 (see Appendix VI for G8 Screening Tool)
* Patient must be ≥18 years of age
* CT or MRI of the head and neck within 8 weeks prior to randomization
* Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.
* Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.

Exclusion Criteria:

* Patients with nasopharyngeal carcinoma.
* Prior systemic therapy (including immunotherapy).
* Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.
* Prior head and neck cancer excluding skin cancer.
* Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension), \>2 nodal levels (Level 1a/b not counted).
* Gross tumour poorly visualized on CT/MRI.
* Definitive radiological or clinically evident distant metastases.
* Scleroderma/CREST syndrome.
Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus a Standard Eyechart.

Open label exploratory study of the EyeQue Insight in healthy volunteers \>=7 years of age.

The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Ages =\>7 y.o.
3. Subjects that are minors (\<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English

Exclusion Criteria:

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
2. Has traveled outside the country within the last 4 weeks
3. Medications:

   a. Taking medications that may affect ability to follow instructions.
4. Eye Disease:

   a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.
5. Subjects that:

   1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
   2. Lack the ability to follow instruction
   3. Lack binocular vision
   4. Lack the ability to maintain both eyes open
Participatory Design of Patient-centered Depression and Diabetes Care

The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older
2. a current diagnosis of Type 2 DM
3. HbA1c 7%
4. current prescription for an oral hypoglycemic agent
5. able to communicate in English
6. willing to give informed consent

Exclusion Criteria:

1. acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
2. significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
3. markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)
HPI in Older Patients Undergoing Major Gastrointestinal Surgery

The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)\<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.

Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)\<65mmHg).

Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.

Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.

Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.

Eligibility Criteria:
Inclusion Criteria:

* the age of patients\>=65 years old
* patients receivedd major gastrointestinal surgery

Exclusion Criteria:

* patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis