cyrilzakka/clinical-trials huggingface dataset:
A Trial of Vitamins and HAART in HIV Disease Progression

This study is a double-blind randomized clinical trial, conducted to examine the effects of multivitamins (including B, C, and E) on HIV disease progression among HIV-positive Tanzanian adult men and women taking highly active anti-retroviral therapy (HAART).

Access to Highly Active Anti-Retroviral Therapy (HAART) for the treatment of HIV in developing regions is limited, but gradually becoming standard of care in some countries. Multivitamin supplements have demonstrated immune-enhancing effects among individuals in pre-HAART HIV disease stages. However, the efficacy and safety of micronutrient supplements need to be documented in the context of HAART. This study is a double-blind randomized clinical trial, conducted to examine the effect of multivitamins (including B, C, and E) on HIV disease progression among individuals taking HAART. Participants are HIV-positive Tanzanian men and women aged 18 years and older, who are initiating HAART at the time of randomization. Eligible individuals are randomized to receive daily oral supplements in one of two intervention groups: a) multivitamins at the single Recommended Dietary Allowance (RDA) level; and b) multivitamins at multiples of the RDA at the same doses used in our previous study "A Trial of Vitamins in HIV Progression and Transmission".

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Men or Women
* 18 Years of Age or older
* Initiating HAART at time of randomization

Exclusion Criteria:

* Pregnant or Lactating Women
* Individuals at pre-HAART disease stages
* BMI less than 16
Genetic and Epigenetic Variations in Heterokaryotypic Monozygotic Twins Discordant for Down Syndrome

Heterokaryotypic monozygotic twins discordant for Down syndrome (DS) are very rare, with an incidence estimated to be less than 1 over 7,000,000 pregnancy in the general population. Sharing the same genetic patrimony, except for an additional chromosome 21 for one of them, any gene-expression difference between them could be attributed only to the supernumerary chromosome 21 and not to polymorphic variability in the rest of the genome. The setting up of a prospective longitudinal study will offer the major advantage of allowing genetic and epigenetic comparisons between them and to obtain important information on the impact of the environment in which they live and grow up.

It is planned to perform multi-omics analyses in order to reach an integrated understanding of the effect of genomic changes on protein expression, on biochemical posttranslational modifications of the synthetized proteins and on the modulation of some signalling pathways.

This study will also allow the generation of induced Pluripotent Stem Cells (iPSCs) from blood cells and fibroblasts of the monozygotic twins useful as in-vitro models to study the pathogenesis and the pathophysiology of Down syndrome. All this may shed the light on new research approaches in Down syndrome.

At last, the human gut microbiome, referring to the total microbial population in the human gastrointestinal tract, although thought to have its own impact, will also be studied. The microbiome is known to play a crucial role mainly in protecting the host against pathogenic microbes, modulating immunity, regulating metabolic processes, and controlling neuropsychiatric behaviour

Eligibility Criteria:
Inclusion Criteria:

* Twins of a heterokaryotypic monozygotic pair discordant for DS
* Twins of a sex- and class of age-matched dizygotic pair discordant for DS,
* Sex- and class of age-matched patient with mosaic T21
* Subject's parents/legal representatives willing to give written informed consent.
* Subject and his/her parents/legal representatives must be able/willing to comply with the protocol.
* Subject covered by social welfare.

Exclusion Criteria:

* None
Neural Predictors of Social Emotion Regulation Training

The purpose of this study is to investigate the basic psychological and neural mechanisms underlying the social regulation of emotion - that is, how one person's actions can impact, or regulate - the emotions of another person - and how this ability changes with practice. As such, this study is not designed to directly address clinical health outcomes and provide no treatment or intervention.

Prior research has demonstrated that helping others regulate their emotions has benefits for the support provider. But little is known about the basic brain mechanisms underlying this ability or how this ability can change with practice. To address these questions, this study has two parts. In the first, functional magnetic resonance imaging (fMRI) is used to gain insight into the brain systems involved in helping others regulate negative emotions by comparing them to the brain systems involved in regulating the participants' own negative emotions. In the second part, participants engage in three weeks of structured practice, or training, in either socially regulating others' emotions or in self-regulating their own emotions. The investigators predict that helping others regulate their emotions will involve many of the same brain regions implicated in regulating one's own emotions, in addition to regions involved in perspective taking and the reward of helping others. Further, when relating the brain data from part 1 to the regulation practice data from part 2, the investigators expect that individuals who in part 1 show greater activity in brain regions supporting either social or self-regulation may be more likely in part 2 to show corresponding improvements in regulation performance. The results of these studies are intended to lay the groundwork for future studies investigating the social regulation of emotion in older adults and clinical populations for whom social support can be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Native English speaker
* Right handed

Exclusion Criteria:

* Current or past history of neurological or psychiatric illness
* Use of psychoactive drugs
* Individuals who have metal devices or implants that cannot be removed from their body (e.g., piercings, pacemakers, copper intrauterine devices (IUDs))
* Pregnant women
Effect of Sufentanil and Ropivacaine

The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.

A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).

Eligibility Criteria:
Inclusion Criteria:

1. Patients had regular prenatal examinations at the outpatient clinic;
2. They were between 25 to 35 years of age)
3. They had a gestational age ≥37 weeks and \< 42 weeks;
4. They had an estimated fetal weight ≥ 2,500 g and \< 4,200 g.

Exclusion Criteria:

* a history of spinal surgery,
* platelet count \<100×109 /L ,
* coagulation disorder,
* sensorimotor disorder of lower extremity,
* leg pain,
* puncture point infection,
* heart disease history,
* pulmonary disease,
* liver and renal function disorder and
* a history of neuropsychiatry drugs.
Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.

This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 6 and 59 months of age seen at the assessment centre during the study period
2. With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
3. With a microscopically confirmed monoinfection of Plasmodium falciparum
4. Able to tolerate oral therapy,
5. Whose parents/guardians have provided written informed consent.

Exclusion Criteria:

1. Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
2. Evidence of severe malaria.
3. Residence at more than 20km from the health clinic.
4. Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness
Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)

Disease recurrence and metastasis are common after curative treatment for patients with esophageal cancer. Thus, it is important to identify the risk factors to predict disease recurrence and metastasis. Pleural lavage cytology (PLC) is reported to be associated with disease recurrence and patient survival in lung cancer, but the value is unclear in esophageal cancer. The aim of this study is to evaluate the value of PLC in esophageal cancer patient in terms of frequencies, association with patient survival, and efficacy of postoperative treatment.

Pleural lavage cytology will be performed before esophageal resection, and after resection, respectively. Frequency of positive pleural lavage cytology will be determined, and the value of pleural lavage cytology for patients with resectable esophageal cancer will be studied.

Eligibility Criteria:
Inclusion Criteria:

* esophageal cancer with histological confirmation before treatment.
* resectable esophageal cancer with clinical T1-4a/N0-3/M0 staging
* potential R0 resection
* no history of other malignancies

Exclusion Criteria:

* severe major organ dysfunction (American society of anesthesiologisits score \>3 )
* patients underwent ESD or EMR
* pleural lavage is unavailable due to adhesions
Duration of Doxycycline Treatment in MEM Patients

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

• multiple erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* extracutaneous manifestations of lyme borreliosis
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain

Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain.

The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain

This study is delimited to the following aspects:

1. Fifty, patients of only females with chronic non specific low back pain more than 3 months.
2. The age will range from 22 to 45 years.
3. The treatment will conduct to three session per week for four weeks .
4. The selected patients will assigned randomly to two equal groups:

1- Group1 (intervention), will do the selected treatment that include electrical stimulation in addition to Core stability exercises program. 2- Group2(control), will do the conventional treatment only.

Eligibility Criteria:
Inclusion Criteria:

* gender is women
* age ranges from 22 to45 years old
* chronic non specific low back pain for at least 3 month
* pain score will between 3 to 6 on visual analogue scale

Exclusion Criteria:

* Any deformity of the spine
* Red flags including serious pathology
* Systemic or inflammatory disease
* sever osteoporosis
* history of tumor or cancer
* spine infection
* history of spine or pelvis surgery or fracture
* cauda equina syndrome
* progressive neurological deficit
* severe instability
* sever cardio vascular or metabolic disease
* history of psychological disease
* anatomical and congenital disturbance
* continuous pain more than 8 on (visual analogue scale)
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women

MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is the major contributor to the LH activity in the product. MENOPUR is approved in more than 130 countries for a variety of strengths and indications. In China, MENOPUR, 75 IU is approved for controlled ovarian hyperstimulation in relation to assisted reproductive technology (ART). The current trial is intended for supporting marketing authorization approval of a new formulation of MENOPUR in China.

MENOPUR is currently available in China as a powder and solvent for solution for injection, containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen, containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for solution for injection, 75 IU is the reference product in this trial.


Eligibility Criteria:
Key Inclusion Criteria:

* Chinese women between the ages of 21 to 40 years at the time of signing the informed consent form
* Non-users or users of the combined oral contraceptive (COC) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive)
* Healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine
* Serum FSH levels ≤5 IU/L and estradiol levels ≤50 pg/mL on Day -3 and Day -1 in TP1

Key Exclusion Criteria:

* Any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important
* A history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb)
* A history of any medical problems that may prevent use of the combined hormonal contraceptive pill
Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results

The aim of this study was to investigate the effects of rapid maxillary expansion on local and systemic oxidative stress levels. Thirty-five volunteer patients (17 females and 18 males) who needed rapid maxillary expansion will be included in the study. Serum and saliva samples will be collected from each patient during four different periods: a week before the treatment (T0), on the day of sutural separation (T1), at the end of the active expansion period (T2), and after the completion of a 3-month retention period (T3). To evaluate the patients' periodontal status, plaque index, gingival index, and probing pocket depth scores will be recorded for each period. 8-hydroxydeoxyguanosine (8-OHdG), total oxidative status (TOS), total antioxidant capacity (TAS), and oxidative stress index (OSI) biomarkers will be evaluated to determine the local and systemic oxidative stress levels.


Eligibility Criteria:
Inclusion Criteria:

* Being between 11-15 years of age,
* Having an indication for maxillary expansion due to maxillary stenosis,
* Being highly cooperative, performing adequate oral care,
* Being periodontally healthy,
* Not having cleft lip and/or palate anomalies,
* Not having any systemic disease,
* Not having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
* Not being substance addicted and not smoking.

Exclusion Criteria:

* Having inadequate oral hygiene
* Being periodontally unhealthy
* Having cleft lip and/or palate anomalies,
* Having any systemic disease,
* Having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
* Being substance addicted and not smoking.
Effects of mHealth on Promoting Self-care Health Management Among Older Adults in the Community

Many of the existing mobile health (mHealth) apps designed in a reactive care approach, in which people do not receive individualized care until they consulted health care professionals through the apps. This proposal endeavors to develop a proactive mHealth application on promoting self-care ability and health among older adults to examine the differential benefits of adding nurse interaction supported by an integrated health-social partnership model in the use of mHealth.

Objectives: Many of the existing mobile health (mHealth) apps designed in a reactive care approach, in which people do not receive individualized care until they consulted health care professionals through the apps. This proposal endeavors to develop a proactive mHealth application on promoting self-care ability and health among older adults to examine the differential benefits of adding nurse interaction supported by an integrated health-social partnership model in the use of mHealth.

Hypothesis to be tested: There is no difference in self-management outcomes, individual and societal benefits between the subjects receiving mHealth+Interactivity, mHealth, and usual care.

Design and subjects: This is a single-blinded, three-armed randomized controlled trial. The subjects are people who are aged 60 or above with chief complaints of either pain, hypertension, or diabetes mellitus.

Instruments: mHealth application designed by the research team with the information technological support by Smartone.

Interventions: mHealth with interactivity group receives both mHealth app and nurse case management supported by a social service team in community. mHealth group will have access to health content on mHealth platform only. Usual care group receives usual community services.

Main outcome measures: Self-management outcomes (self-efficacy, pain score, blood pressure, capillary blood glucose), individual (quality of life, depression) and societal benefits (institutionalization and health service utilization).

Data analysis: Generalized Estimating Equation (GEE) is used to determine the between-group effects, within-group effects, and the interaction effects.

Expected results: Older adults would benefit from supported self-care equipping them with sufficient knowledge, skills and confidence to lead to relatively independent life at home.

Eligibility Criteria:
Inclusion Criteria:

* people who are aged 60 or above
* with chief complaints of either pain, hypertension, or diabetes mellitus
* living within the service areas and (4) using smartphone

Exclusion Criteria:

* already engaged in other mHealth programs
* diagnosed with psychiatric problems
* bed-bound
* living in area with no internet coverage
Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)

Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.

Investigators will conduct a cluster-randomized controlled trial with 416 children ages 5-11 years with persistent or uncontrolled asthma from 26 Bronx schools. Schools will be randomly assigned to either (1) the Asthma-PASS intervention or an asthma management (AM) comparison group. Both groups will participate in an existing classroom-based daily activity program. Enrollment will occur over 4 consecutive school years with 6-8 schools joining the study each year. The investigators will assess the effectiveness of Asthma-PASS in reducing asthma morbidity, and improving PA as well as additional clinical and functional outcomes. The investigators will also identify potential mediators and moderators of the intervention effect. They will evaluate the process of intervention implementation by applying the RE-AIM framework.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma (based on parent report with validation from the child's physician).
* Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
* Attending kindergarten through 5th grade in Bronx elementary schools
* Parent is able to speak and understand either English or Spanish.
* Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above).

Exclusion Criteria:

* No access to a phone to conduct follow-up surveys.
* Family plans to leave the school or city in less than 6 months.
* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease.
* Child is unable to participate in routine PE classes as per physician-completed sports participation form.
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
* Child is a participant in a concurrent asthma intervention study.
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation

The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. We hypothesize that if the STS test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6MWD).


Eligibility Criteria:
Inclusion Criteria:

* patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.

Exclusion Criteria:

* patients with cystic fibrosis who are under the age of 6,
* patients with cystic fibrosis who are not admitted for a pulmonary exacerbation,
* patients with cystic fibrosis who are not being followed regularly by physical therapy (\>5x/week) throughout their inpatient admission,
* patients with cystic fibrosis who are unable to follow instructions for standardized testing,
* patients with cystic fibrosis who are not medically stable to participate in submaximal exercise testing.
* patients whose inpatient admission is anticipated to be \<1 week.
* Patients who are readmitted to the hospital within the year will not be included in the study more than once.
IFH Depression Registry 2013

This is an observational registry intended to track depression scores of patients over time in treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PHQ-9 score greater than or equal to 10, have a depression diagnosis active on the problem list, or have had a depression encounter diagnosis used in the past year, and are in behavioral health treatment at the Institute.

Exclusion Criteria:

* Patients under the age of 18