cyrilzakka/clinical-trials huggingface dataset:
Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura

The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP). This includes evaluating the rate and type of treatment failure.

With this study we hope to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP). This includes evaluating the rate and type of treatment failure.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in the trial based on the following criteria:

* Patients must have TTP with platelet count \< 100,000/mL and microangiopathic hemolytic anemia which is defined as presence of at 3-10 fragmented red blood cells (schistocytes) per high power filed on the peripheral blood smear.
* Either gender, age 17 or older
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* TTP not related to underlying cancer, treatment of cancer or transplantation
* New onset TTP, or previously diagnosed TTP with an unmaintained remission for \>12 months.
* LDH \>2X upper limit of normal
* Prothrombin time (PT), partial thromboplastin time (PTT) normal
* Direct antiglobulin test (DAT) negative
* Subject has provided written informed consent
* Patients who have received up to 3 plasmapheresis.

Exclusion Criteria:

Patients will be excluded from the trial based on the following criteria:

* A diagnosis of AIDS. Patients with HIV infection with absolute CD4 counts \>200/ul and no active, significant opportunistic infection are eligible
* Patients with a known hepatitis C infection (HCV) and/or with hepatitis B
* Patients receiving pheresis more than once a day
* Recent (within 1 year) bone marrow or hematopoietic stem cell transplant
* Patient is on calcineurin inhibitors, or is unable to come off them
* Acute or chronic disseminated intravascular coagulation (DIC), defined by D-dimers \>8mg/ml and fibrinogen \< 100 mg (0.1g)/dl
* A diagnosis of metastatic or non-metastatic malignancy other than basal cell carcinoma.
* Malignant hypertension (systolic blood pressure \[BP\] \> 200 mm Hg or a diastolic BP \> 130 mm Hg)
* Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment). Eligibility resumes 3 days after delivery
* Patients with family history of or a previous diagnosis of congenital TTP
* Patients with hemolytic uremic syndrome (HUS)
* Patients with sepsis
A Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit

A Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of LANLUMA V to Improve Jawline Contour Deficit


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who aged 18 years or older (subject to the date of signing the informed consent), male or female;
2. Subjects with a MJAS score of moderate to severe levels (2\~3 scores) in terms of bilateral jawline contour as evaluated by the blinded evaluator, and the scores of bilateral jawline contour must meet the criteria but not required to be the same;
3. Subjects who are seeking to receive corrective treatment for jawline contouring;
4. Subjects who are in good health and suitable to receive corrective treatment for jawline contouring as evaluated by the blinded evaluator;
5. Subjects who voluntarily sign the ICF, understand and accept the study duration, and are able to comply with all requirements including treatment, follow-ups and other study procedures as scheduled;

Exclusion Criteria:

1. Subjects with non-aging skin laxity and lipoatrophy which may affect the evaluation of efficacy in the midface or mandibular region as identified by the investigator;
2. Subjects who are known to be allergic to any local anesthetics (such as lidocaine or other amide anesthetics), or have a history of severe allergic reactions or anaphylactic shock;
3. Subjects who have residual defects, scars, deformities, tattoos, perforations, hair, unhealed wounds, active skin diseases or inflammations (such as eczema, acnes, psoriasis, and herpes zoster), abscesses, carcinogenesis or precancerous lesions and other conditions that may affect evaluation of vision and efficacy or increase the risk of treatment in the injection and evaluation areas;
4. Subjects with unstable and/or irreproducible malocclusion, or bruxism, hypertrophy or asymmetry of masseter, lockjaw, active temporomandibular disorders or active periodontal diseases;
5. Subjects who have a tendency to develop keloids, hypertrophic scars, or any other healing disorders.
Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics

This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old, 11-14 weeks of pregnancy, at least one risk factor for GDM, signed a written informed consent

Exclusion Criteria:

* Diabetes mellitus or abnormal glucose metabolism before pregnancy; Hyperemesis gravidarum (urine ketone positive)); Thyroid dysfunction; Asthmatic patients;Hypertensive diseases that are difficult to control;Severe hepatic and renal insufficiency or severe electrolyte disturbance; Malignant tumor;Acute inflammation;lung disease; Patients with gastritis, duodenum and other digestive system diseases;Those with upper respiratory or oral problems who cannot cooperate with expiratory collection;smoker
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Eligibility Criteria:
Inclusion Criteria:

* Providers who schedule patients for a lung cancer screening at either of the two VA sites.
* Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.

Exclusion Criteria:

* Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.
* Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.
* Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.
* Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.
First-in-Human Single and Multiple Dose of EB8018

The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.

Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging evidence suggests that the microbiome plays an important role in triggering an abnormal mucosal immune response in patients with Crohn's Disease. Independent studies have demonstrated an imbalance of the microbiome with a significant increase of E coli with invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral small molecule that is designed to block FimH thereby preventing the entry of AIEC into the gut wall thereby disarming the bacteria without disrupting the gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age ≥ 18 to ≤ 55 years of age
* Body mass index of 19.0 to 30.0 kg/m2
* Normal ECG, showing no clinically relevant deviations, as judged by the investigator (QTcF ≤450 ms)

Exclusion Criteria:

* Subjects who have received any Investigational Medicinal Product in a clinical research study within the previous 3 months.
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* Current smokers and those who have smoked within the last 12 months
* Positive drugs of abuse test result
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever, even inactive, is not allowed.
* Chronic infection or acute significant infection or fever within the previous 5 weeks prior to the start of IMP administration
* Malignancy or prior malignancy, with a disease-free interval of less than 5 years after diagnosis and intervention
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.


Eligibility Criteria:
Inclusion Criteria:

* 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
* Life expectancy of at least 6 months
* Aged 18 years or older
* WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
* Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
* Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
* An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
* CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
* Serum Lactate Dehydrogenase (LDH) must be = or \< 2 x upper limit of normal
* Able to provide written informed consent

Exclusion Criteria:

* Any untreated intracranial disease
* Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
* Evidence of leptomeningeal disease on pre-local treatment MRI scan
* Patients with prior cancers, except:

  * Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
  * Successfully treated basal cell and squamous cell skin carcinoma;
  * Carcinoma in-situ of the cervix
* A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
* Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial
Evaluation of Tooth Sensitivity and Whitening Effects of Different Content Teeth Whitening Agents

The goal of this clinical study is to evaluate the success of different whitening agents in whitening teeth in healthy volunteers aged 18-50. Also, patients' tooth sensitivity will be assessed after application. The main questions it aims to answer are:

Is the teeth whitening success of different whitening agents similar? Did participants develop tooth sensitivity to whitening agents? The researchers will compare the whitening success of 3 different whitening agents and changes in tooth sensitivity within 1 year after application.

Participants:

Whitening agent will be applied in the clinic Visit our clinic for checkups and records after 1 week, 2 weeks, 1 month, 2 months, 4 months , 6 months and 1 year after application

The participants in the study were healthy volunteers between the ages of 18-50. The number of volunteers was determined by using other studies similar to this study. There are 60 volunteers in three groups, 20 volunteers in each group. A different whitening agent is applied to each group by the researcher.

The researcher did not include volunteers with poor oral hygiene, smoking, tooth sensitivity, caries, or medication use in the study.

The researcher began the study by performing color measurement and sensitivity assessment before the procedure. Then he applied the whitening agent. The volunteers who underwent the whitening procedure will be evaluated in terms of both color measurements and sensitivity changes at the end of the treatment, 1st week, 2nd week, 1st month, 2nd month, 4th month, 6th month, and 1st year control sessions.

Each patient has their own evaluation form. There are different fields for both color and sensitivity in the form according to the control dates. All numerical data are recorded in their own fields.

Eligibility Criteria:
Inclusion Criteria:

* Vital teeth
* Healthy gums
* No tooth sensitivity
* External discoloration ( tea,coffee..)
* Good oral hygiene
* No allergy to the material to be used

Exclusion Criteria:

* Decayed and devital teeth
* Presence of gingival bleeding
* History of trauma
* Presence of fractures, cracks and aesthetic restoration
* Smoking
OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced or metastatic colorectal cancer;
* no previous treatment with chemotherapy for metastatic disease;
* at least one measurable lesion.

Exclusion Criteria:

* radiotherapy to any site within 4 weeks before study;
* untreated brain metastases or primary brain tumors;
* clinically significant cardiovascular disease;
* chronic daily treatment with high dose aspirin (\>325 mg/day);
* other co-existing malignancies or malignancies diagnosed within last 5 years.
Metabolomic Analysis of Exhaled Breath Condensates in Patients With COPD and Bronchiectasis

Metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. It may reflect changes in biological function. Collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. This study is conducted for the metabolomic analysis of the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.

Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. The aims of this study are: (1)Collecting and metabolomic profiling of the EBCs from patients with COPD/bronchiectasis; (2) Comparing the profiles of these patients obtained during stable and acute exacerbation periods; (3) Comparing the profiles of these patients with and without Pseudomonas colonization/infection; (4) Correlation of EBC metabolomic profiles with clinical phenotypes, severity and outcomes of these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with COPD or bronchiectasis

Exclusion Criteria:

* not willing to sign ICF
A Study to Evaluate Unintended Prolonged Opioid Use

Researchers are trying to better understand how people who are prescribed opioids for short-term use, go on to receive this type of medication on a longer-term basis.

Identify incident cases of UPOU and prospectively assess their characteristics in comparison to new opioid users who do not progress to UPOU. At each site, opioid-naïve adults who receive opioid prescriptions will be enrolled. Opioid prescriptions (both written and filled) and self-reported opioid use will be followed, and those subjects progressing to UPOU will be identified in real time. Matched samples of patients who do and do not develop UPOU will be recruited for assessment of framework elements related to patient characteristics,including biochemical confirmation of opioid use, pain-related measures (including psychological variables), and medical and social histories. Using the information gathered in Aim 1, structural equation modeling will be utilized to evaluate the associations UPOU and the patient domain.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* No use of opioids for 6 months prior to the issuance of the initial opioid prescription
* Willingness to participate in all aspects of the study including use of the Hugo platform on their personal smartphone

Exclusion Criteria:

* Cancer-associated pain
* Concurrent treatment for cancer (e.g., chemotherapy, radiation therapy)
* Residence in an extended care facility
* Any operation or hospitalization within the past 6 months
* Mental health disorders that could impede functioning in an ambulatory care setting (e.g., schizophrenia, dementia)
* Non-English speaking individuals
* No smartphone
* Use of a pharmacy that is not compatible with the Hugo platform.
Action Observation in Hip Replacement

Postoperative rehabilitation is required for a successful outcome following total hip arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.

Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip replacement.

Exclusion Criteria:

* bilateral hip replacement
* previous total hip replacement.
* pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer.

Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.

Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics.

Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group.

In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated.

However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse.

This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions.

Patients referred for adjuvant radiotherapy after breast conserving surgery will preferably be randomized, depending on the indication, to a study-arm with whole breast irradiation (WBI) +/- SIB or to a study-arm with WBI+/- SIB and lymph node irradiation (LNI).

If patients after breast conserving surgery (BCS) have a strong preference for 5 or 15 fractions, they will be invited to enter the parallel observational arm (patient preference).

Patients referred for adjuvant radiotherapy after mastectomy +/- LNI accepting to participate, can choose a 5 or 15-fraction schedule. No randomization is foreseen in this last observational group.

Eligibility Criteria:
Inclusion Criteria:

* breast conserving surgery or mastectomy for breast carcinoma
* multidisciplinary decision of adjuvant irradiation
* absence of distant metastases
* informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* History of previous radiation treatment to the same region
* Bilateral breast irradiation
* Life expectancy of less than 2 years
* Planned reconstructive breast surgery
* Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, ...
* Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study