cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I

The purpose of this study is to develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this study is to apply the treatment to larger-scale trials to determine its effectiveness and generalizability.

ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type. Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable. Effective treatments for ADHD-I are still needed.

Participants are randomly assigned to receive either a behavioral intervention or treatment as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill development groups, family meetings, and consultation with the child's teacher to address attention problems and areas of impairment at home and school. Parent and child interviews, teacher and child ratings, and psychoeducational testing are used to assess participants. Participants are assessed post-treatment and at a 2-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* ADHD, Predominantly Inattentive Type
* Public or private school attendance
* English speaking
Microbiota is Related With Increasing Infection Rates After Splenectomy

Studies has shown an increasingly infection rate after splenectomy, and there is a potential correlation between microbiota and immune system. investigators suppose that increasingly infection can be associated with the alteration composition of the gut microbiota after splenectomy. It's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

The spleen is crucial in regulating immune homoeostasis through its ability to link innate and adaptive immunity and to protect against infections. Asplenia refers to the absence of the spleen, a disorder that is rarely congenital and is more frequently as a result of surgery. Splenic hypofunction, as a result of asplenia can lead a series of changes in body systems. Recent study has show an increasingly infection rate after splenectomy including abdominal infection, pulmonary infection and cranial cavity infection.

The gastrointestinal tract plays host to a diverse and metabolically complex community of microorganisms. Recent literature suggests that organisms in the gastrointestinal tract, referred to collectively as gut microbiota, play an indispensable role in the maintenance of host's homeostasis. Study has proved a potential correlation between microbiota and immune system. Lymphocyte, in either peripheral circulation or mesenteric lymph node, altered can lead to an composition change in microbiota.

Investigators suppose that this phenomenon can be associated with the alteration of the resident commensal microenvironment after splenectomy compared to commensal communities. It's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* All the patients underwent an total splenectomy in the First Affiliated Hospital of Harbin Medical University from January 1st, 2015 to May 1st, 2017. Each participant provided a fresh stool sample in hospital when following-up.

Exclusion Criteria:

* Use antibiotics and probiotics 3 mouth before samples collection.
* Other severe abdomen injury
* Underwent abdomen organ resection surgery
* Other digestive system disease
Clinical Outcomes for Deep Brain Stimulation

The object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.


Eligibility Criteria:
Inclusion Criteria:

* Levodopa responsive Parkinson disease OR
* Medically refractory Essential Tremor OR
* Medically refractory Dystonia

Exclusion Criteria:

* Dementia (Mattis Dementia Rating Scale \<130)
* Structural abnormalities precluding intracranial surgery
Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers

Latino Kick Buts (LKB) is a smoking cessation treatment program available to patients identified as smokers at the University of Rochester Medical Center. Latino Kick Buts smoking cessation mobile program encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities; and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost). LKB utilization among Latino smokers remains minimal. The aim of this pilot study is to identify types of text message that are more effective to enrolling Latino smokers in the LKB.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Hispanic/Latinos
* be 21 years old or older
* have smoking status recorded in the EMR
* patient of URMedicine

Exclusion Criteria:

* Not Hispanic/Latino
* under 21 years of age
* not a smoker
Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes

The SCIentinel-prolong study systematically analyzes humoral autoantibody responses and thier interaction with post-spinal cord injury (SCI) immune-deficiency and infections as well as their association with the clinical course of rehabilitation. Therefore, molecular and immunological tests in blood and cerebrospinal fluid specimen are combined with clinical outcomes ranging from neurological function, neuropathic pain and spasticity to walking tests and measures of independence in daily living within the first year after SCI. Including a control group with participants suffering from vertebral fractures without SCI allows to differentiate between neurological and general injury and treatment effects.


Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic SCI, American Spinal Injury Association Impairment Scale (AIS) A to D, neurologic level of injury C3 - L2 or acute vertebral fracture without SCI
* Inclusion within 21 days post-injury
* For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).

Exclusion Criteria:

* Non-traumatic SCI
* Severe multiple trauma
* Serious traumatic brain injury
* Pre-exiting neurological diseases
* Malignant Neoplasia, except in complete remission for 5 years
* Rheumatic diseases / collagenosis / vasculitis
* Other autoimmune diseases
* Pre-existing chronic infection
* Severe alcohol or drug addiction
* Pregnancy or lactation
* Simultaneous participation in interventional clinical trials
* For centers in Germany or Switzerland only: SCI-treatment using Methylprednisolone (according to NASCIS).
Identifying Barriers and Strategies to Support Self-efficacy for Medication Adherence With Text Messaging

The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.


Eligibility Criteria:
Inclusion Criteria:

1. Receiving care at the VUMC/Matthew Walker clinic
2. Diagnosed with SCD, asthma, or both
3. Currently taking daily medications for SCD, such as hydroxyurea, asthma, or both
4. Having access to a mobile telephone and/or computer
5. Age 12-70 years

Exclusion Criteria:

1. Unable to perform interviews or surveys
Bronchopulmonary PK of AT-527 (R07496998)

This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)


Eligibility Criteria:
Inclusion Criteria:

* Subjects must agree to use birth control, as required by the protocol.
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities
Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP

To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-38 years
* Body mass index (BMI) between 18 and 30
* Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
* Testosterona, FSH (follicle-stimulating hormone), LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
* No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria:

* Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
* Data suggestive of possible ovarian failure
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy
CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap

A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of head and neck cancer
* Received mandibular reconstruction
* All patients were followed up postoperatively for at least one year

Exclusion Criteria:

* Patients received bone graft for jaw reconstruction before mandibular reconstruction
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC
* Stage IIIb-Stage IV NSCLC
* ECOG performance status of 0-2
* Adequate liver and renal function
* Adequate bone marrow reserve

Exclusion Criteria:

* Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
* Histologically confirmed mixed tumors containing small cell elements
* Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
* History of bone marrow transplantation or stem cell support
* Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
* History of HIV
* Grade 3 or 4 peripheral neuropathy
* Weightloss greater than 5% within 6 months
* Uncontrolled pleural effusion
Knee Arthroplasty Registry

Objective

Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.

Examine the relationship between processes of care, hospital and surgeon associated outcomes.

Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.

Analyze and design ancillary studies to address unanswered questions.

Disseminate findings through publication in peer-reviewed scientific journals.

Population: All male and non-pregnant females undergoing knee arthroplasty.

Study Design: Prospective, consecutive series on an unlimited number of patients.

Data Collection

Clinic Data:

Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results

Surgical Data:

Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results

Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view

Eligibility Criteria:
Inclusion Criteria:

1. Patient is a male or non-pregnant female over the age of 21.
2. Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
3. Patient has signed and dated an IRB approved consent form.
4. Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
5. Patient has failed to respond to conservative treatment modalities.

Exclusion Criteria:

1. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
2. Patient is a prisoner.
Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers

The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.

The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate (Cit-HDF) in 3 months can reduce the inflammation markers, evaluated by a Predialytic value of Beta2-microglobulin (B2m), CRP and IL6 compared to traditional concentrated acetic acid (Ac-HDF).

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

* the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);
* the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);
* the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;
* the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);
* the variation of calcifications observed by:

  * the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
  * a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);
* dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

Eligibility Criteria:
Inclusion Criteria:

. Patients clinically stable.

* age\> 18.
* HDF in renal replacement therapy for more than 1 month.
* good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Exclusion Criteria:

* Life expectancy \<3 months.
* With residual renal function\> 500 ml / day.
* Vascular access with CVC
Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

This study includes screening and treatment and follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

* 20 years ≤ age ≤ 45 years.
* Voluntarily participate in the study and sign the ICF.
* Have the ability to understand the study.

Exclusion Criteria:

* With history of chronic or serious illness.
* With any medication within 28 days prior to administration;
* Plan to undergo surgery during the research period;
* With any situations unsuitable to participate in this study.
Checklist-guided Shared Decision-making for Code Status Discussions in Medical Inpatients.

This cluster-randomized, multicenter trial is designed to investigate the effect of checklist-guided shared decision-making including decision aids and communication of expected outcome on patients' decision regarding their code status, and at the same time, if it improves decision-making quality as judged by patient's decisional comfort, patient knowledge and involvement in decision-making and patient satisfaction. Patients in whom resuscitation is considered as futile will be treated separately in an ancillary project. In these patients a checklist to communicate the futility and the medical consequences will be used.


Eligibility Criteria:
Inclusion Criteria:

1. physician level

   - residents on the medical wards will be the primary level of randomization.
2. patient level - any adult (\>18 years) patient that is admitted for in-hospital care will be eligible.

Exclusion Criteria:

1. physician level

   - no exclusion criteria for physicians except if they refuse participation
2. patient level

   * patients unable to complete questionnaires or unable to follow code status discussions due to (1) intoxication, (2) paracusis; (3) serious psychiatric conditions (e.g., psychosis, depression with suicidal tendency, stupor), (4) cognitive impairment (e.g. dementia, delirium).
   * patients prior included in this study (i.e., patients who are hospitalized for the second time)
Development and Evaluation of a Self-Management Model for Cancer Rehabilitation

Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model.

During the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed with head and neck malignancy.
* Experiencing psychological distress.
* Aged between 18 and 70 years.
* Patients scheduled to receive antitumor treatment in a day hospital or outpatient setting.
* ECOG performance status score of 0-2.
* Patients voluntarily participate, fully understand, and are able to independently complete the questionnaires.

Exclusion Criteria:

* A history of other malignancies within the past 5 years.
* A history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder.
* Patients currently receiving other psychological treatments or taking psychiatric medications.
Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.


Eligibility Criteria:
Inclusion criteria for the outcome assessment (household survey):

* Residing in one of the selected households
* Age ≥40 years

Exclusion criteria for the outcome assessment (household survey):

* Pregnant
* Inability to provide written informed consent