cyrilzakka/clinical-trials huggingface dataset:
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants

This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders.

This is a study will be based on the adaptation of the intervention previously described and published by Guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. The intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.

Preterm babies, specifically with gestational age \< 33+6 weeks, will be recruited and assigned (randomized) into an a Multisensory stimulation + Family Education Group (MSG) or a Family Education Only Group (FEG).

When the clinical condition of the child is stable and after a short training, parents of the MSG will be asked to carry out up to two treatment sessions per day with their child, until they reach the 8th post-term week. Sessions will initially be carried out together with a therapist who will have the task of transmitting the necessary skills to parents/caregivers. The therapist will assist parents through practical demonstrations, theoretical explanations and by answering the parents' questions.

The treatment will consist of sessions of approximately 25-30 minutes. The main purposes of the intervention will be clearly explained to the parents, and in particular the goal of maintaining a calm and natural interaction during the session.

In addition, all families will receive the evidence-based program of Family Education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship.

It takes its conceptual basis from the Mother Infant Transaction Program (MITP). It is a specific and re-adapted version for the preterm infant hospitalized in NICU

The family education group sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NIC directly at the child's bed between the operator and one or both parents. Each meeting involves the discussion of one of the following topics.

Eligibility Criteria:
Inclusion Criteria:

* premature infants born \<29 weeks of gestation age or premature infants (born \< 33+6 weeks gestation age) with a documented brain injury .

Exclusion Criteria:

* Clinical instability, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
* Genetic-malformative conditions
Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization

Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.

Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.

Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.


Eligibility Criteria:
Inclusion Criteria:

* Subject over 15 years of age
* Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
* Included after a first inpatient hospitalization in specialized care
* Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
* With medical insurance
* Can be reached by telephone

Exclusion Criteria:

* Uncompensated psychiatric pathology
* Refusal to participate in the study
* The inability to consent to care (patient or his/her legal representative)
* Pregnancy
* Major incapable subject or under guardianship or judicial protection
* Homelessness
* No mastery of reading and writing
Medical Expulsive Therapy of Single Distal Ureteral Stones

Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.

The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.

Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.


Eligibility Criteria:
Inclusion criteria:

* patients with a single 2 to 7mm ureteral stone below the common iliac vessels

Exclusion criteria:

* presence of multiple ureteral stones
* renal insufficiency (glomerular filtration rate below 60 ml/min)
* urinary tract infection
* a solitary kidney
* pregnancy
* history of ureteral surgery or previous endoscopic procedure
* hypersensitivity to tamsulosin
* current alpha-blocker, calcium-antagonist or corticosteroid medication
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment

This study looks at how well oral vinorelbine works in treating advanced breast cancer. It looks at women who have already had this treatment or are currently having it.

This is an international, multicenter, retrospective and prospective, observational study.

The study will comprise of two cohorts:

* Retrospective: Patients who started OV treatment for ABC between 2011 and 2020 will be enrolled in the retrospective cohort study. The observation period for retrospectively included patients will extend from the initiation of OV treatment to the date of death, date of last contact or end date of retrospective observation period, whichever occurs first. The end date of retrospective observation period will be set as the date of the inclusion of the first patient in the study (First Patient In= FPI).
* Prospective: Patients initiating OV treatment and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires will be enrolled in the prospective cohort study. The enrollment period is expected to extend up to 17 months from study start. The study observation period will extend up to 2 years after last patient first visit (around 24 months after treatment initiation).

Due to the observational nature of this study, no additional medical procedures or in person clinical visits beyond routine oncology care will be required for this study.

Eligibility Criteria:
Inclusion Criteria:

Female aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation

Confirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy

Initiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort

Willing and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort

Provision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations

Exclusion Criteria:

no exclusion criteria for patients in this study
Texas Childhood Obesity Research Demonstration (TX CORD) Project -Primary Prevention Study

A systems approach emphasizes the linkage between individual behavior change strategies and social and physical environmental changes, which act synergistically to facilitate (or inhibit) healthy eating and active living. We hypothesize that among low income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce BMI compared to primary prevention alone.


Eligibility Criteria:
Inclusion Criteria:

* Children attending selected elementary schools or Head Start Centers in the catchment areas.
* Ages 2 to 12

Exclusion Criteria:

* Children who are special needs
FMF and Atheroscelerosis

The aim of this study is to search for subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of FMF.

* To describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms.
* To mention the most common genetic variants reported in FMF patients in Upper Egypt, and to correlate the genetic variant with the risk to develop atherosclerosis.
* To assess the growth parameters in patients with FMF and compare it with the control group.
* To estimate the differences in Complete blood count (CBC) parameters, lipid profile, CIT in patients with FMF and control group.
* To search for subclinical atherosclerosis in patients with FMF based on their lipid profile and CIT.

Eligibility Criteria:
Inclusion Criteria:

1. Age at enrollment less than18 years.
2. Both sexes.
3. Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. \[10\]

Exclusion Criteria:

1. Patients with acute or chronic active infections.
2. Patients with pre-existing illness as chronic lung, liver or renal diseases.
3. Patients with diabetes mellitus, atherosclerotic vascular disease.
4. Patients with malignancy
The Effct of Chitooligosaccharide on Immune Function in Healthy Adults

Functional properties of chitooligosaccharides have been studied for antitumor activity, immunostimulating effects, antimicrobial activity, free radical scavening activity, adn angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity and absorbability studies have demonstrated that chitooligosaccharides have high absorbability and are essentially non-toxic. In the present study, we prepared a chitooligosaccharide with high absorbability and evaluated its effects on activation of immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults.

This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by PBMCs pre- and postintervention were measured simultaneously after stimulation with lipopolysaccaride.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults(the ages between 20\~50 year)

Exclusion Criteria:

* food allergy and allergy skin disease
* severe liver and kidney disease
* pregnant, lactating women
* cancer, stroke, etc.
Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction

Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease

Aim of the work

We aim to examine the prevalence of KC among patients already diagnosed by endocrinologist with TGD.

Materials and methods

Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:

VA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study

Inclusion citeria All patients diagnosed as thyroid gland dysfunction Control group

Exclusion criteria Uncooperative patients

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as thyroid gland dysfunction

Exclusion Criteria:

* Uncooperative patients
Nexium Capsules LDA Specific Clinical Experience Investigation

The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Eligibility Criteria:
Exclusion Criteria:

* Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy).
* Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.
68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers

To evaluate the potential usefulness of 68Ga-NK224 positron emission tomography/computed tomography (PET/CT) for the evaluation of PD-L1 expression in primary and/or metastatic tumors, compared with histopathological results.

Participants with cancer underwent 68Ga-NK224 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the PD-L1 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-NK224 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
* (iii) patients who had scheduled 68Ga-NK224 PET/CT scans;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions;
* (ii) patients with pregnancy;
* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.

This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.

To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 75 years-old
* Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
* Working understanding of the English language and able to fully understand the procedure
* Capable of providing informed consent
* Able to complete online, in-person or phone surveys for the purposes of follow-up
* Capable of understanding pre- and post-procedure care instructions
* Ambulatory at baseline
* Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

* Age \< 35 or \> 75 years old
* Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
* Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
* Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
* Co-morbidity with rheumatologic condition, inflammatory arthritis
* Currently undergoing immunomodulatory therapy
* Uncontrolled endocrine disorder
* BMI \>35
* Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C \>7.0)
* Pregnancy or planned pregnancy
* previous stem cell injection into treatment joint
* Patient scheduled to undergo any concomitant surgical procedures.
* Coagulopathy or anticoagulant treatment
* Chronic pain involving multiple body parts or opioid medication management
Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort

The purpose of this study is to assess the longitudinal association between alcohol consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to establish a sample repository.

Heavy alcohol consumption in an HIV-infected person may accelerate HIV disease progression and end organ disease with one leading explanatory pathway being via enhanced microbial translocation and inflammation/altered coagulation. Heavy alcohol consumption and HIV infection are both causes of microbial translocation, the process by which bacterial products leak across the gastrointestinal membrane with resultant destructive immune activation. Among HIV-infected people, high levels of microbial translocation (as measured by soluble CD14) and inflammation/altered coagulation (as measured by IL-6 and D-dimer) are each associated with an increased risk of death. Of importance, among HIV-infected persons, heavy drinking is also significantly associated with higher levels of D-dimer in cross-sectional studies. Of note, initiation of antiretroviral therapy (ART) is associated with a reduction in D-dimer levels. Yet the following is not known: is there a longitudinal relationship between alcohol consumption and these biomarkers independent of ART?

Thus, as part of the Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH)Consortium, the investigators seek to create the Russia ARCH cohort (n=375) from participants of a recently completed NIAAA-funded randomized controlled trial (RCT) of HIV infected Russian heavy drinkers.

The investigators will be collecting blood from participants at baseline, and at 12- and 24-months post enrollment. In addition to collecting and storing blood samples the investigators will be administering surveys to participants at all 3 timepoints. The investigators will conduct phone interviews with participants at 6- and 18-months post enrollment. The investigators will conduct laboratory tests on the stored samples, including measures of microbial translocation (sCD14) and inflammation/altered coagulation (IL-6/D-dimer) and PEth.

This study will clarify the association between alcohol and key biomarkers over time in HIV-infected heavy drinkers. In addition, the investigators will be collecting and storing blood samples from participants in the study to use for the analyses specified and for future studies looking at HIV-infected heavy drinkers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* HIV-infected
* Provision of contact information for two contacts to assist with follow-up
* Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg
* Possession of a home or mobile phone
* ART-naive at the time of enrollment

Exclusion Criteria:

* Not fluent in Russian
* Cognitive impairment resulting in inability to provide informed consent
Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

The primary objectives of the Multi MERCI trial were:

* to evaluate the addition of the Merci L5 Retriever
* additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted)

Per the Multi MERCI protocol, up to 230 patients could be treated at up to 30 centers.

The intended trial indication for the Merci L5 Retriever was to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients that were contraindicated or failed treatment with intravenous t-PA were allowed to be enrolled under the Multi MERCI protocol.

Per the Multi MERCI protocol, following inclusion of the Merci L5 Retriever the operating physician was required to initiate treatment with the Merci L5 Retriever. At the physician's discretion, subsequent passes could be made with the Merci L5 Retriever, Merci X6 Retriever and/or Merci X5 Retriever.

Adverse events were adjudicated by an independent Data Safety and Monitoring Board (Capital DSMB).

Eligibility Criteria:
Inclusion Criteria:

* Angiographically confirmed large vessel ischemic stroke (occlusion may include the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries)
* Intervention is able to be performed within 8 hours of symptom onset
* Patients \> 18 years of age
* NIHSS score 8+
* Failed IV t-PA treatment or contraindicated for IV t-PA

Exclusion Criteria:

* International Normalized Ratio (INR) \> 3.0
* Platelet count \< 30,000
* Heparin use in previous 24 hours with PTT \> 2X normal
* Baseline bloog glucose \< 50 mg/dL
* Baseline computed tomography (CT) showing mass effect with midline shift
* Severe sustained hypertension (SBP \> 185 or DBP \> 110) that cannot be controlled with medication
* Patient is pregnant, has anticipated life expectancy \< 3 months, or has severe allergy to contrast medium
* Arterial stenosis \> 50% proximal to embolus
* Excessive arterial tortuosity that precludes the study device from reaching the target area