cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study

The goal of this observational study is to learn about compare the effect of removing animal milk from diets on the symptoms of FD patients in describe participant population.

The main question it aims to answer are:

• Can removing milk and dairy from diets be used to treat FD patients?

The participants will be divided into two groups and will do the following;

* removing milk and dairy products under the advice of a dietician without medical treatment
* receiving medical treatment without restricted diet.

Researchers will compare two groups to the effect of removing milk from diet on the symptoms of FD patients.

In this cross-sectional cohort study, 120 patients with FD diagnosed by the Rome IV criteria were included. Patients were divided equally into two groups; those who removed milk and dairy products under the advice of a dietician without medical treatment and those who did not. For determining the severity of symptoms, "The gastrointestinal Symptom Rating Scale (GSRS)" was used at the onset of the study and the end of the one-month follow-up period.

Between the two groups, there was no statistically significant difference regarding age, body mass index (BMI), frequency and duration of symptoms, weight changes in the last six months, FD subtypes, and upper GI endoscopy results (p\>0.05). Female patients outnumbered men in the animal milk removal group (p=0.01). Although the patients in the animal milk removal group had higher GSRS scores at the beginning (p=0.01), both groups had similar GSRS scores at the end of the study (p=0.99). After one month follow-up period, GSRS scores have improved in both groups compared to the baseline (p=0.01). However, the decrease in the GSRS total symptom score was significantly higher in the animal milk removal group compared to the free diet group (p=0.01). In the evaluation of GSRS symptom subsets, a statistically higher reduction was observed in 7 of the 15 subsets in the animal milk removal group compared to the free-diet group (p\<0.05).

Of the 120 FD patients who followed up for one month, 60 who removed milk products had a more significant reduction in GSRS symptom score and 7 of the 15 symptom subset scores than 60 patients receiving an unrestricted diet.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65
* having at least one of the complaints of postprandial fullness, early satiety, epigastric burning and pain
* the onset of the complaint is at least 6 months ago and at least one complaint has been going on at least 3 days a week for the last 3 months
* no underlying organic pathology is detected in the examinations.

Exclusion Criteria:

* being outside the age range of 18-65
* having alarm symptoms such as vomiting, gastrointestinal bleeding, and weight loss of 5% or more in the last 3 months
* presence of comorbidities such as dementia, CVD, psychiatric diseases
* covid-19 positivity during the research
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal

The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal.

Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.

This study will last 96 weeks. At study entry, all participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits during the study; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires. An off-study visit will occur at approximately one month after Week 96, with assessments and procedures similar to visits during the study.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Have never taken ARV drugs
* CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
* Willing to stay in the study area for the duration of the study
* Willing to use acceptable forms of contraception

Exclusion Criteria:

* HIV-2 infected
* Systemic chemotherapy (except interferon) within 6 months prior to study entry
* Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
* Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
* Have taken certain medications within 30 days of study entry
* Pregnancy or breastfeeding
Module on Preventing Fire, Burns and Scalds Injury Among Children

The main aim of this intervention study is to test the hypothesis if school based educational intervention program will significantly improve the knowledge of primary school student on childhood burn prevention in Kuala Lumpur. The secondary aim the evaluate the association of demographics background, burn injury history with knowledge on burn. The study was conducted in 12 primary school in Kuala Lumpur from 1st January 2015 to 31st December 2017 in three different phases.

According to World Health Organization data, approximately 10% of all unintentional injury deaths are due to fire-related burns. In Malaysia, burn represent about 5.6% (745 cases) of all injuries among children. As childhood burn was not considered as a child health problem comparing to other childhood illnesses, parents and children tends to have less priority in overcome this issue. This highlights the need to transfer the knowledge especially to the children on the burn prevention. By implementing this module on preventing fire, burns and scalds injury among children, knowledge on main causes of burns and their immediate management can be improved at young age.

Eligibility Criteria:
Inclusion Criteria:

* Students who are aged 7 till 11 years old
* Parent or guardian of each selected student above

Exclusion Criteria:

● Students under special needs class (Pendidikan Khas)
Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Completion of Study B5201002.
* Documented diagnosis of SCD.
* At least 6 years of age.
* Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
* Diagnosis of VOC necessitating IV opioids and admission to the hospital.
* Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.

Exclusion Criteria:

* Non-compliance with study procedures in the double blind study (B5201002).
* Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
* Clinically significant deterioration in renal function in Study B5201002.
* Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
* Active use of illicit drugs and/or alcohol dependence.
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.

Long-term outcomes include detection of delayed adverse event(s) for any new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorder, rheumatologic or other autoimmune disorder, hematologic disorder, new incidence of infection related to RPx product and new incidence of herpetic-like infection. Patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of RPx.) No study interventions will be administered in this observational study. Patients will be contacted by telephone every 3 months (Q3M) for 5 years from enrollment on this study. Participant visits may occur in person, over the phone, by video conference, or other technology.

Eligibility Criteria:
Inclusion Criteria:

Patients are eligible for inclusion in the study only if they meet all of the following criteria:

1. Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
2. Patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Patients are excluded from the study if the following criterion applies:

1. Cannot comply with the requirements of the study.
Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation

The purpose of this study is to evaluate safety and effectiveness of the peripheral mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF levels, immunological profile and brain functional connectivity changes in patients with Parkinson's disease.

Patients will be submitted to 8 sessions of peripheral mechanical stimulation of the feet or sham stimulation along 4 weeks.

Evaluations will be performed before and after the first session, after the forth and the eighth session.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease based on clinical criteria, dopamine transporter (DaT) scans and/or magnetic resonance imaging;
* Able to walk 25 feet unassisted or with minimal assistance;
* Presenting freezing of gait;
* Aged between 50-85 years;
* Minimum score of 20 in the Mini Mental State Examination (MMSE);

Exclusion Criteria:

* Secondary musculoskeletal disorder involving the lower limb, as chondral injuries, ligament and ankle sprains which may impede the realization of the gait by pain or motion disability;
* Peripheral neuropathy;
* Not attending all the treatment;
* Absolute contraindications for fMRI (just for fMRI examination);
* Presence of deep brain stimulation;
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Phase Ia:

To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.

Phase Ib:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors.

Phase II:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the study and sign the informed consent form.
2. Aged 18 years or older at the time of signing the informed consent form.
3. Subjects must have one measurable lesion (per RECIST 1.1).
4. Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or ≤ Grade 1 (neurotoxicity ≤ Grade 2 acceptable).
5. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1.
6. Expected survival ≥ 12 weeks.
7. Female subjects or male subjects of childbearing potential must take effective contraceptive measures from the time of signing the informed consent form to 30 days after the last dose of GFH925, or to 60 days after the last dose of cetuximab. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days (inclusive) prior to initiation of study treatment.
8. The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.

Exclusion Criteria:

1. Significant cardiovascular system disease.
2. Subjects with unstable brain metastases diagnosed by investigators.
3. Significant gastrointestinal diseases, such as intractable hiccup, nausea, vomiting, severe gastrointestinal ulcers, cirrhosis, active gastrointestinal bleeding, or other diseases that affect swallowing tablets or significantly affect oral drug absorption; subjects with severe portal hypertension caused by the presence of Budd-Chiari syndrome or portal emboli in subjects with liver cancer also need to be excluded.
4. Presence of serious acute or chronic infections.
5. Pregnant or lactating women.
6. Known allergy to the study drug or any component of its formulation.
7. Other conditions that the investigators consider inappropriate for participation in this study.
Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory

This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).

This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
* Parent and Teacher Ratings \>85 percentile on inattention and/or hyperactivity/impulsivity scales
* Estimated Intelligence Quotient (IQ) \> 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test

Exclusion Criteria:

* Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
* Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
* Use within 14-days of a monoamine oxidase inhibitor
* History of side effects on any methylphenidate preparation that required stopping the medication
* Inability to swallow a capsule or tablet
* Chronic treatment with coumarin, clonidine, or tricyclic antidepressants
A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services

The primary aim of this study is to determine the feasibility and acceptability of the W-GenZD mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the Children's Hospital of the King's Daughters. The secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. The third aim of this study is to investigate potential differences between group differences on working alliance. An exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.


Eligibility Criteria:
Inclusion Criteria:

1. Have completed triage at the Children's Hospital of the King's Daughters (CHKD) and have been deemed appropriate for the low-intensity intervention track, given presenting problem(s) of depressive or anxiety symptoms
2. Adolescent 13-17 years of age, inclusive
3. U.S. resident
4. Both adolescent participant and parent/guardian are able to read and write in English
5. Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
6. If currently prescribed antidepressant medications (e.g. escitalopram/Lexapro, fluoxetine/ Prozac), antipsychotic medications (e.g. aripiprazole, asenapine, olanzapine, paliperidone, quetiapine, risperidone), or stimulants (e.g. amphetamine/Adderall, Methylphenidate/Ritalin) and alpha agonists (e.g. atomoxetine/Strattera, Guanfacine/Intuniv) they are at a regular, stable dose for at least 60 days at screening
7. Not currently actively engaged is psychotherapy
8. Available and committed to engage with the program and complete assessments for a 8-week duration
9. Family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms

Exclusion Criteria:

1. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
2. Lifetime diagnosis of bipolar disorder
3. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome)
4. Current diagnosis of developmental delay or intellectual disability
5. Suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
6. History of (a) drug and/or alcohol abuse within the past 12 months
7. Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
8. Previous Woebot application use
9. Enrollment of more than one member of the same household
PRobiotics for EVEry Newborn Trial

The aim of the study is to compare prevention (oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks) with treatment-as-needed (supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age). This is a single site pilot study to assess feasibility for a full trial.

One in five infants experience colic, defined as recurrent and prolonged episodes of crying and fussing with no obvious cause in healthy infants less than 5 months of age. There is evidence to support the role of the probiotic L. reuteri for treatment of colic in breastfed babies and for prevention of colic. However, these two options (prevention vs treatment-as-needed) have not been previously compared head-to-head. The study aims determine if oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks (prevention) is superior to treatment-as-needed, as measured by daily cry/fuss duration at 6 and 12 weeks of age.

Eligibility Criteria:
Inclusion Criteria:

1. 1 to 7 days of age
2. term (37 to 41 weeks)
3. breast or formula fed
4. birth weight \> 2500 grams
5. parental consent

Exclusion Criteria:

1. congenital or other medical disorders
2. parents unable to communicate in English or French
Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists.

Exclusion Criteria:

* Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months
* Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study
* Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc.
* Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
* Had a surgical condition or a major physical illness
* Were pregnant or breast-feeding
* Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.