cyrilzakka/clinical-trials huggingface dataset:
Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 6-24 months at time of enrollment
* Height/length for age Z score of less than -2.5
* Child lives with parent/legal guardian

Exclusion Criteria:

* Presence of acute malnutrition (weight for length/height Z score of less than -2)
* Presence of other severe medical illness (e.g. congenital heart disease, genetic abnormality)
High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents

The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents


Eligibility Criteria:
Inclusion Criteria:

* BMI \>+ 2SD (age adjusted)
* Fitted for group treatment
* at least one parent attending the treatment

Exclusion Criteria:

* Not able to join treatment
* not able to walk
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED

Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.

Eligibility Criteria:
Inclusion Criteria:

* VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
* Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
* Unanesthetized Schirmer of \> 0 and ≤ 10 mm.
* Must not have used Artificial Tears during the Screening period.
* IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.

Exclusion Criteria:

* Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
* Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) \< 5 mmHg or \> 24 mmHg.
Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis

This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

This is a prospective cohort study using single cell transcriptomic profiling and plasma DNA tissue mapping on patients with pneumonia with or without sepsis. The major application of the investigator's study would be the discovery of gene expressions in different leucocytes and plasma DNA associated with each type of organ dysfunction in sepsis. These include cardiovascular, respiratory, hepatic, renal, neurological and haematological dysfunction. This would help prediction, diagnosis and development of therapies to treat sepsis. Leucocyte single cell transcriptome and plasma DNA tissue mapping may addresses the limitations of current evidence in 3 ways: (1) differentiate patients with uncomplicated pneumonia versus pneumonia with associated sepsis, (2) correlation with types and severity of organ dysfunction and (3) identifying molecular phenotypes of sepsis.

Eligibility Criteria:
Inclusion Criteria:

All of the following:

* newly admitted adult patients (≥ 18 years old)
* suspected community acquired pneumonia (CAP)
* compatible history of either sputum or cough or fever or rigors within 1 week
* chest X-ray infiltrates

Exclusion Criteria:

Any of the following:

* chest symptoms not solely accounted by pneumonia (cardiac failure, non cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome)
* immunosuppression
* current malignancy
* blood samples for gene expression could not be taken within 24 hours of admission
* prisoner/cogni tive impairment
* blood transfusion within 1 month
* hospitalization within 1 month
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma

RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma.

OBJECTIVES: I. Define the immunological parameters of cytolytic T cell and T helper cell activity associated with skin testing and vaccination with autologous lung tumor associated antigen and detoxPC in patients with curatively resected stage I, II, or IIIA non-small cell lung cancer (NSCLC) or stage I or II mesothelioma. II. Evaluate any responses associated with an enhanced antitumor immune status in this patient population with this treatment regimen.

OUTLINE: Patients undergo delayed type hypersensitivity skin testing with autologous tumor associated antigen (TAA) and memory antigens (i.e., Monilia, PPD, and Trichophyton) intradermally at 1-4 weeks following surgical tumor resection. At week 4-9, patients receive low dose cyclophosphamide IV once. At 3 days following chemotherapy, patients receive autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks. At 2-3 weeks following vaccination, patients undergo repeat skin testing. At week 6-12, patients with a positive skin test undergo biopsy of the skin test/vaccination site followed by leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity. Patients with stable or regressive disease receive additional vaccination courses at week 20 and thereafter. Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary stage I (T2, N0), II, or IIIA non-small cell lung cancer (NSCLC) curatively resected by pneumonectomy, lobectomy, or wedge resection OR Stage I or II mesothelioma Measurable disease Lesions must be at least 3 cm in diameter

PATIENT CHARACTERISTICS: Age: 20 to 70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy except nonmelanoma skin cancer No history of severe allergies No history of autoimmune disease Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent glucocorticoids Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent nonsteroidal antiinflammatory drugs
Norepinephrine Consumption After Prophylactic Ondansetron

This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.

Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients
* Between the ages of 18 and 40 years
* Scheduled for elective caesarean section with spinal anesthesia

Exclusion Criteria:

* History of hypertension
* History of severe hepato-renal disease,
* sensitivity or contraindication to ondansetron,
* Drug or alcohol abuse
* Contraindication to regional anesthesia.
A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.

This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 25+
* Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
* Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
* Generally healthy - do not live with any uncontrolled chronic diseases.
* Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.
* If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Planning to undergo any procedure related to their vaginal health.
* Started any new medications or supplements that target vaginal health in the past 3 months.
* Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
* Women who are pregnant, breastfeeding, or attempting to conceive
* Unwilling to follow the study protocol
* Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.
Kinesiotaping and Constraint Induced Movement Therapy in Subacute Stroke

In stroke patients, the most common neurological deficits were motor impairment, loss of somatosensation, abnormal muscle tone, and impaired fractionated movement at affected limbs. Therefore, the investigators try to facilitate upper extremity function and normalize the muscle tone to enlarge their capacity to perform daily activities and to improve life quality by modified constraint-induced movement therapy (mCIMT) and Kinesiotaping (KT).

The investigators will collect 90 subacute stroke patients with hemiplegia in this study. These 90 patients will be randomly divided into 3 groups. In KT group (n=30), the patients will perform Kinesiology taping for 5 days per week for 3 weeks. In mCIMT group (n=30), the patient will receive constraint the unaffected limb for 2 hours a day, 5 days a week for three weeks. In KT+mCIMT group, the KT and mCIMT interventions would be performed for 5 days a week in three weeks. All the patients in KT, CIMT and KT+mCIMT groups will receive 20-minute hand function training twice daily for 5 days per week for 3 weeks. Before intervention, immediately and 3 week later after intervention, all patients will receive the physical examinations including motor recovery stage (Brunnstrom stage), spasticity (modified Ashworth scale and Tardieu scale), and sensation. Fugl-Meyer assessment for upper extremity (FMA-UE), box and block test, Simple Test for Evaluating Hand Function (STEF), and Wolf Motor Function Test for hand function, ADL and quality of life assessment and musculoskeletal sonography for affected forearms will be also evaluated in this study.

The aims of this study are:

1. To investigate the effect of Kinesiotaping and modified CIMT in improving upper extremity function and spasticity for subacute stroke patients with hemiplegia.
2. To explore the role of sonoelastography and shear wave velocity in poststroke spasticity assessment.


Eligibility Criteria:
Inclusion Criteria:

* The patients have a stroke with hemiplegia (duration is 3\~12 months after stroke).
* Patients who are able to perform hand grasp.
* Patients who could slightly do fingers extension and minimal wrist extension. (ability of extension at least 10 degrees at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist.)

Exclusion Criteria:

* age is younger than 18 years or older than 80 years
* previous history of upper extremity tendon or neuromuscular injury
* any other systemic neuromuscular disease
* cognition or language impairment leading to communication difficulty
* allergy history when application of KT materials
Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases

Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.

Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively.


Eligibility Criteria:
Inclusion Criteria:

* liver transplants, performed from January 2015 to December 2020

Exclusion Criteria:

* pediatric LT; LT for non-tumor lesions; LT for other malignant tumors (cholangiocarcinoma, carcinoma of gallbladder, mixed carcinoma, and secondary tumors); re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 1 week due to post-operative hemorrhage after LT.
MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy

This study aims to validate the value of tumor involvement features based on MRI in cervical cancer, facilitate the development of a more appropriate model for risk stratification, and help patients with varying risk profiles make appropriate decisions in treatment selection and follow-up plans.

Even with the development of advanced technology, the prognosis for CC patients who received radiotherapy is still an intractable problem. Almost 40% suffered disease recurrence among locally advanced patients after radiotherapy and the reported 5-year overall survival is 50-70%. The present FIGO staging is controversial in pre-treatment assessment, which is mainly based on physical examination. An ambiguous diagnosis leads to different treatment strategies and follow-up plans, which is associated with prognosis non-improvement. Incorporation of the tumor involvement features based on the MRI into pre-treatment assessment could standardize and improve the consistency and repeatability of diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* (1) pathologically confirmed CC, (2) initially treated in our center

Exclusion Criteria:

* (1) lack of pre-treatment MRI, (2) prior anti-tumor treatment, (3) pelvic surgery history, (4) incomplete therapy, (5) loss of follow-up
Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)

Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.

This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 22 years or older at the time of screening
2. Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder
3. Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
4. Currently residing in the United States

Key Exclusion Criteria:

1. Risk of suicide or has attempted suicide within 24 months of the screening visit
2. Moderate to severe substance use disorder
3. Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder
4. Currently pregnant or planning to become pregnant during the treatment period

Note: Other protocol-defined inclusion/exclusion criteria applied.
Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study

Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.

Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).


Eligibility Criteria:
Inclusion Criteria:

* Major
* Fluency in French
* Fibromyalgia diagnosis

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism
HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM

This will be a two-arm cluster randomized controlled trial. The control group can share their Center for Disease Control and Prevention certified online HIV results (COHIV) with another party freely through a social networking tool, while the intervention group will be asked for the COHIV before he can see the COHIV of his friend. The investigators hypothesize that the requires exchange will promote HIV testing and thus reduce HIV incidence among MSM.

This will be a two-arm cluster randomized controlled trial. A WeChat-based mini program has been developed to send and receive Center for Disease Control and Prevention certified online HIV results (COHIV). WeChat is the ubiquitous communication and social networking tool in China. We will use the social network method for participant recruitment. A social network consists of one ego and some alters, and in this study a social network will be considered as a cluster. In a social network, ego is the MSM who shares his certified HIV test results with or without exchange mechanism by the WeChat mini program, while alters are recipients of the shared links. So the ego can shares his COHIV with many alters. After an ego shares the certified HIV test result with exchange mechanism (intervention group) or without exchange mechanism (control group) with their WeChat contactors, the people who click the link will be candidate alters in our study. 1020 alters will be recruited as the participants and the randomization would be based on the unit of social network, which means the alters will be randomized into the same group that the ego is in.

Participants in the intervention group will receive his friend's COHIV and can only open it when the participants share their own in exchange. If the participant already has the COHIV, the system will lead the user to send his COHIV to the friend. If the participant does not have the COHIV, the system will guide him to make online appointment at the testing clinic. The participants in the control group will be able to receive and open the friend's COHIV entirely at the friend's discretion without the mandatory exchange requirement. The system will also guide users on how to get an HIV test by making appointments with the MSM friendly clinics in the mini program. Questionnaires are scheduled at baseline, month 3, 6 and 9. Follow-up questionnaires will be delivered through WeChat. The primary outcome is HIV testing rate of the participants in the past three months.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than18 years old
* Had anal sex with men
* HIV unknown or negative
* Plan to live in Guangzhou for the next year

Exclusion Criteria:

- Cannot complete questionnaire survey due to difficulty in reading or communication
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).

The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form
2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for ≥ 8 weeks prior to Visit 1

Meeting all of the following criteria during the screening period:

1. FVC ≥40% predicted of normal
2. DLCO corrected for Hgb ≥25% and \<80% predicted of normal.
3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings