cyrilzakka/clinical-trials huggingface dataset:
A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis

The purpose of this study is to determine whether PUR118 is safe and tolerable in a population of subjects with Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant, non-lactating healthy female.
* Age 18 to 55 years of age (inclusive) on day of signing informed consent.
* Subject has a BMI of 17 or greater.
* Subject has a confirmed diagnosis of cystic fibrosis documented by a compatible clinical or radiographic presentation, and definitive accepted lab and clinical criteria (e.g., sweat chloride \> 60 mEq/L or 2 disease causing CFTR mutations) OR is regularly attending a Consultant led clinic where the diagnosis of Cystic Fibrosis is not in doubt.
* Subject has an FEV1 ≥ 45% of predicted at screening.
* Subject has an oxygen saturation \>92% on room air as determined by pulse oximetry at screening.
* Subject is a non-smoker or ex-smoker has not smoked for at least six months prior to screening.
* Subject is otherwise medically stable without clinically significant abnormal screening results that depart from their usual baseline level of health as a subject with CF.
* Must be willing and able to communicate in English and participate in the whole study.
* Must provide written informed consent.

Exclusion Criteria:

* Subject has unstable lung disease, as defined by a change in medical regimen during the preceding 2-weeks, or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse), or in the opinion of the Investigator, has had a decline in pulmonary status within the last year not considered a part of the usual, chronic progression of CF lung disease and part of their baseline health condition as a subject with CF.
* Subject has had an exacerbation of respiratory symptoms within the past 30 days that required initiation of a new or altered respiratory therapy.
* Subject had either an upper or lower respiratory illness within the 30 days prior to dosing days, or has symptoms from such an illness that have not resolved.
* Subject has a history of lung transplantation.
* Females of child bearing potential who are pregnant, or lactating. Females who are sexually active and either not surgically sterile or not willing to use an acceptable form of contraception
* Clinically significant abnormal biochemistry, haematology or urinalysis not consistent with CF as judged by the Investigator
* Failure to satisfy the Investigator of fitness to participate for any other reason.
Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females

Symptoms of vaginitis are common among adolescent females, although studies have shown that neither experienced clinicians nor patients can accurately diagnose the cause of vaginitis based on symptoms alone. The purpose of this study is to investigate the accuracy and acceptability of self-diagnostic methods for vaginitis in adolescent females.

Vaginal symptoms are common among adolescent females. Vaginal symptoms can result from alterations in the normal flora such as candidiasis or bacterial vaginosis (BV), or from sexually transmitted infections (STIs) such as trichomonas vaginalis (Tv). However, studies have shown that neither experienced clinicians or patients can accurately diagnose the etiology of vaginitis based on symptoms alone, and the standard evaluation (pelvic examination and wet mount) has limitations.

As an alternative to the standard evaluation, there are several objective, point-of-care tests that can be performed on vaginal secretions, which could be useful in discriminating between the various causes of vaginitis. These include a rapid test for trichomonas vaginalis, a rapid test for bacterial vaginosis, and the vaginal pH and amine test. The aims of this study are to explore the feasibility, accuracy (e.g., correlation, sensitivity, specificity) and acceptability of self-performed versus clinician-performed tests for vaginitis in adolescent females.

Approximately 300 adolescent females will undergo self- and clinician-testing for both STI and non-STI vaginitis. Subjects will be randomized into two groups. Group 1 will perform self-testing for the first half of the study before receiving clinician-testing for the remainder of the study. Group 2 participants will receive clinician-testing for the first half of the study before performing self-testing for the remainder of the study. All participants will have a discussion with the clinician to compare the results of self-performed tests with the results obtained by the clinician. Investigators will assess their acceptance of self- and clinician-testing before testing, after testing, and after the discussion with the clinician.

Eligibility Criteria:
Inclusion Criteria:

* Sexual intercourse in the last 6 months
* Agree to perform self-testing
* Agree to pelvic examination

Exclusion Criteria:

* Have taken antibiotics used to treat vaginal infections in the 2 weeks prior to study entry or have used vaginal creams or medications in the 2 weeks prior to study entry
A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices

The main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients.

The main question is to answer:

1. Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
2. Is the MI-R1 lower limb walking machine safe?

Participants will:

1. The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
2. Perform functional testing on the 0th, 14th, and 28th day of training.
3. Observe whether there is any discomfort or safety during the rehabilitation training process.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stroke through CT or MRI, and only accompanied by hemiplegia on one side, with first-time onset or previous episodes without residual neurological dysfunction;
* Vital signs stable, neurological symptoms no longer aggravate after 48 hours, no severe cognitive impairment or aphasia, and cooperate with training;
* Modified Ashworth score for lower limb ≤ level 2, standing balance function level ≥1;
* Voluntarily participating in this trial, understanding and cooperating with the entire trial process, and signing a written informed consent form.

Exclusion Criteria:

* Bone, joint, muscle disease, or lower limb disabilities (such as severe osteoporosis, fractures, spinal instability, severely limited joint range of motion, severe limb muscle contractures, deformities, etc.) or diseases that affect balance and walking;
* Stroke caused by cerebellar brainstem injury and cortical injury;
* Patients with severe primary diseases such as cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems, as well as critically ill and psychiatric patients;
* Other contraindications or complications that may affect walking training treatment;
* Patients with local skin damage or pressure ulcers in the lower limbs;
* Patients with peripheral nerve injury in the lower limbs;
* Inappropriate body shape for robots (height\<150cm or\>190cm, or weight\>85 kg);
* Planned pregnancy or pregnant and lactating women;
* Participants in other clinical trials within the past 3 months;
* Severe cognitive impairment;
* Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations);
* The researchers believe that it should not participate in this clinical trial.
Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

This is a single center, single arm, prospective, phase II clinical study. The main purpose of this study is to evaluate the efficacy and safety of anlotinib in the treatment of steroid dependent/refractory chronic graft-versus-host disease (cGVHD) after allogeneic peripheral blood stem cell transplantation (allo HSCT).

Anlotinib 8mg qd po for 6months if no progression in 4weeks or reach PR in 3months

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be diagnosed as hematopoiesis disorders and receiving hematopoietic stem cells transplantation.
2. Steroid dependent or refractory classic chronic GVHD disease defined as modified National Institutes of Health criteria(2014) below at any time post-hematopoietic cell transplant(post-HCT)

   1. Dependent disease, defined as, when glucocorticoid (prednisolone doses greater than or equal to(\<=) 0.25mg/kg/day or \<=0.5mg/kg every other day(prednisolone doses) due to recurrence or progression of cGVHD manifestations, it is considered as steroid-dependent disease if the lowest tapering dose of the second occasion is equal or higher than the lowest tapering dose of the first occasion
   2. Refractory disease, defined as, when cGVHD manifestations progress despite the use of a regime containing glucocorticoid (prednisolone at \>=1mg/kg/day for at least 1 week) or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5mg/kg/day or 1mg/kg every other day) for at least 4 weeks.
3. Participants must be receiving baseline systemic glucocorticoid therpy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting anlotinib.
4. At the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting anlotinib.
5. Neutrophil≥1.5×109/L，platelet≥50×109/L
6. Karnofsky or Lansky performance status\>=60
7. Participants should sign the agreement.

Exclusion Criteria:

1. Known or suspected active acute GVHD.
2. Current treatment with a tyrosine kinase inhibitor, purin analogs or other cancer chemotherapy in the 4weeks prior to starting study drug.
3. Concomitant use of warfarin or other Vitamin K antogonists.
4. Known bleeding disorders or hemophilia.
5. Known history of human immunodeficiency virus or active with hepatitis C. virus or hepatitis B virus.
6. Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicine or recent infection requiring systemic treatment .
Endoscopic Ultrasound (EUS) Artificial Intelligence Model for Normal Mediastinal and Abdominal Strictures Assessment

Therefore, a high number of procedures is necessary to achieve EUS competency, but interobserver agreement still varies widely. Artificial intelligence (AI) aided recognition of anatomical structures may improve the training process and inter-observer agreement. Robles-Medranda et al. developed an AI model that recognizes normal anatomical structures during linear and radial EUS evaluations. We pursue to design an external validation of our developed AI model, considering an endoscopist expert as the gold standard.

Endoscopic ultrasound (EUS) is a high-skilled procedure with a limited number of facilities available for training. Therefore, a high number of procedures is necessary to achieve competency. However, the agreement between observers varies widely. Artificial intelligence (AI) aided recognition and characterization of anatomical structures may improve the training process while improving the agreement between observers. However, developed EUS-AI models have been explicitly trained or only with disease samples or for detecting abdominal anatomical features.

In other fields as Radiation Oncology, developed AI models have been widely used. They must recognize in unison healthy and disease strictures throughout any part of the human body during the contouring. It avoids unnecessary irradiation of normal tissue. EUS-AI models not trained with healthy samples can cause an increase in false-positive cases during real-life practice. It implies potential overdiagnosis of abnormal/disease strictures. EUS-AI models not trained with samples outside

Using an automated machine learning software, Robles-Medranda et al. have previously developed a convolutional neuronal networks (CNN) AI model that recognizes the anatomical structures during linear and radial EUS evaluations (AI Works, MD Consulting group, Ecuador). To the best of our knowledge, this EUS-AI model is the first trained with EUS videos from patients without pathologies and, thus, with normal mediastinal and abdominal organ/anatomic strictures. In this second stage, we pursue to design an external validation of our developed AI model, considering an endoscopist expert as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients with no history of the thorax and abdominal abnormalities confirmed through an imaging test requested for healthcare purposes in the last twelve months (e.g., thorax X-ray and abdominal ultrasound or thorax and abdominal CT)
* Patients who undergo EUS assessment due to chronic dyspepsia.

Exclusion Criteria:

* Morphological alteration on at least one mediastinal and abdominal organ/anatomic strictures documented through any imaging test or EUS.
* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV);
* Refuse to participate in the study or to sign corresponding informed consent.
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo

Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \> or equal 25 and \< 35
* Use of effective contraception in women of childbearing age

Exclusion Criteria:

* Pregnant women (positive pregnancy test) or breastfeeding
* Anti-hypertensive or cholesterol treatment
* HIV infection or HCV
* Hepatic and/or severe renal failure
* Heart attack within 6 months prior the selection
* Heart failure known
* Inflammatory disease known
* Cancer or have had cancer within 3 years prior to the study except for basal cell skin cancers
* Diabetes defined by blood glucose greater than or equal to 1.26 g/L
* Gastrointestinal disease known
* Bariatric surgery
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.

Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.

The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender and 18-60 years of age;
* Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer);
* Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;
* Spinal cord injury vertebral level should be between C4 and T10;
* Subjects must be able to read, understand, and complete the VAS;
* Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures.

Exclusion Criteria:

* A history of hypersensitivity or other adverse reaction to lithium;
* Significant renal, cardiovascular, hepatic and psychiatric disease;
* Significant medical diseases or infection;
* Addison's disease;
* Debilitation or dehydration;
* Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;
* A history of alcohol abuse or drug abuse;
* Pregnant or lactating women;
* Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;
* Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study;
* Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally;
* Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.

The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.


Eligibility Criteria:
Inclusion criteria:

* Relapsed or refractory de novo classical Hodgkin lymphoma
* Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
* Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease
* Adequate organ function

Exclusion criteria:

* Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
* Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1
* Prior allogeneic hematopoietic stem cell transplantation
* Known clinically active central nervous system involvement
* Known additional malignancy that is progressing or requires active treatment
* Has a known history of Human Immunodeficiency Virus (HIV)
* Has known active Hepatitis B (HBV) or Hepatitis C (HCV)
* Active autoimmune disease requiring systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Comparison of a Demand Oxygen Delivery

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.

The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only. Pulse flow oxygen concentrators have been used clinically in adults. However, there is limited experience with this technology in children. The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data.

This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow. The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea, neurocognitive and cardiac outcomes. A separate Institutional Review Board (IRB) protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board.

Eligibility Criteria:
Inclusion Criteria:

1. Age 5-17 years with or without Down Syndrome (DS).
2. Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
3. Absence of clinically significant hypoxia defined as oxygen saturation \< 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.

Exclusion Criteria:

1. Current CPAP use with documented compliance (\> 4 hrs/ night; \> 70% of nights).
2. Oxygen saturation \< 90% at rest during wakefulness
3. Chronic daytime or nighttime use of supplemental oxygen.
4. Unable to participate in a Polysomnogram (PSG).
5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
Serological Test for the Diagnosis of TB

TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.


Eligibility Criteria:
Inclusion Criteria:

* Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology)

Exclusion Criteria:

* Immunosuppression