cyrilzakka/clinical-trials huggingface dataset:
Promoting Infant-Directed Speech in Ghana

The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.

While parents universally use "baby talk" to soothe an infant or get her attention, engaging in a second form of infant-directed speech (IDS) - talking to young children with complete, if simplified, sentences and a rich variety of words -- varies by socioeconomic status (SES) within societies and across societies. Preliminary evidence collected from Burkina Faso and Ghana, as well as anecdotal experiences in Kenya and Uganda, are consistent with this: It is less common for parents in sub-Saharan Africa to talk to their infants than it is among parents in the US. Because IDS promotes cognitive development of children, gaps in IDS compound the disadvantages that children in poorer families face.

The most likely explanation for the IDS deficit among the poor is inaccurately low expectations about the pace of child development. A large body of literature in the US has shown that the lower the parents' SES, the lower their expectations about when children will master certain cognitive skills, e.g. speaking in a partial sentence of 3 words or more.

The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.

Parental beliefs about and practices of IDS will be evaluated through data obtained from a series of questions on these topics at baseline, during a short phone follow-up survey, and at endline. This will mainly be self-reported although we hope to explore the observation of said practices at endline. Results of the treatment arm will be compared to that of the comparison group to determine if the intervention is effective. To assess IDS behavior and child language development at endline, the LENA system (Language ENvironment Analysis) which produces two key measures It produced two key measures: adult word count (language the child hears) and conversational turns (the sounds/words the child produces in conversation with adults/others) will be compared among groups. Conditional on funding, there may be a 2-year follow-up survey (i.e. second endline) to measure children's cognitive development.

Eligibility Criteria:
Inclusion Criteria:

* Adult women who visit government health facilities/outreach posts for antenatal, postnatal, or child welfare clinic visits in Tamale and surrounding areas, Ghana.
* Must be age 18 to 40 years old
* Be either pregnant or mothers of young infants at the time of baseline.
* Must speak English or Dagbani (a language local to Tamale and the surrounding areas)

The endline survey will also include child participants.

Child Inclusion Criteria:

* Must be the biological children (or wards) of the baseline respondents
* Must be age 2-18 months old during the endline period
Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness

The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.

Exclusion Criteria:

* patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects with Myelodysplastic Syndromes

This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes


Eligibility Criteria:
Inclusion Criteria:

1. Agree to participate in this trial and voluntarily sign the informed consent form.
2. Men or women ≥ 18 years at the time of signing the informed consent form.
3. Subjects with MDS previously treated or untreated with de novo or secondary MDS.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.

Exclusion Criteria:

1. Prior treatment with more than 1 cycle of azacitidine or decitabine.
2. Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.
3. Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
4. Previous diagnosis of malignant tumor.
5. History of immune deficiency.
6. Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.
Evaluation of Nebulization and Positive Expiratory Pressure Combination

The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination


Eligibility Criteria:
Inclusion Criteria:

* Stable cystic fibrosis patients older than 16 y.o.
* Healthy subjects

Exclusion Criteria:

* Kidney failure
* No pregnancy
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.

The primary objectives of the study are to confirm the safety of oral acetaminophen in extremely low birth infants, given concomitantly with intravenous ibuprofen and also to determine its efficacy in significantly increasing the rates of ductal closure when compared to only intravenous ibuprofen therapy. Hence primary outcome variable include patent ductus arteriosus closure success rate, based on the 2-D transthoracic echocardiographic evidence.

This study is a single center, randomized, double blinded, placebo controlled trial. Preterm infants with gestational age of with a gestational age ≤27 6/7 weeks by the best obstetric estimate are eligible for enrollment.

For randomization, the study population will be stratified to two subgroups based on gestational age (GA ≤24 weeks and \> 25 weeks). Randomization will occur by using computer generated random sequence, using a 4-block design, with 1:1 parallel allocation. Allocations include treatment and control arm. Treatment arm will receive combination of intravenous ibuprofen and oral acetaminophen, while control arm will receive intravenous Ibuprofen and oral placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infant ≤27 6/7
2. Written parental consent is obtained
3. Infant requires respiratory support
4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:

   1. Ductus size ≥ 1.5 mm
   2. Maximum flow velocity through the ductus ≤ 2 m/s
   3. Left atrium to aorta ratio ≥ 1.4
   4. Wide pulse pressure
   5. B-type natriuretic peptide (BNP)
5. Attending neonatologist made decision to treat patent ductus arteriosus

Exclusion Criteria:

1. No parental consent
2. Infants \> 21days of postnatal age
3. Congenital anomalies such as cardiac or multiple anomalies
4. Infection (e.g., septicemia, pneumonia)
5. Bleeding disorder or platelet count\< 50,000/ml
6. Acute kidney injury (AKI)defined as oliguria (urine output\< 0.5 ml/kg/hr for 16hrs) and/or serum creatinine \> 1.5 mg/dl
7. Elevated liver enzymes (\>2 fold from upper normal limits)
8. Pulmonary hypertension or right to left shunt through the ductus arteriosus
9. Diagnosis of necrotizing enterocolitis
10. Unable to tolerate oral medications at the time of enrollment.
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance.

Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds.

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for GDM using continuous glucose monitor. Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Eligibility Criteria:
Inclusion Criteria:

* Live, non-anomalous fetus
* Literacy in English, Spanish, Mandarin, or Arabic
* Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

* \<18 years at EDD
* pre-existing diabetes or diagnosis of GDM prior to 24 weeks
* multi-fetal gestation
* known major fetal anomaly
* known allergy to insulin
* chronic maternal corticosteroid use
* diagnosis of GDM based on finger sticks alone
* patients who have contraindication to oral glucose tolerance test
* a primary language other than English, Spanish, Mandarin, or Arabic
Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to surgeries with general anesthesia,
* healthy or with minor diseases completely controlled by regular use of medications (ASA I or II according to the classification of physical state by the American Society of Anesthesiologists).

Exclusion Criteria:

* patients with past of chronic use of benzodiazepines and/or illicit drugs,
* seizures or panic disorder.
Bespoke vs Standard Instrumentation in TKR

Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.

This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.

Total knee replacement (TKR) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. However, this means that up to 25% of patients are not entirely satisfied with their TKR. The longevity and stability of a TKR is greatly dependent on the accuracy of the initial surgery. Deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'Patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. This will allow for individual bony cuts specific to the patients own anatomy.

'Patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. This could result in improved early range of movement and decreased pain following surgery. The total knee replacement used in this study will be the GMKSphere (Medacta International) TKR. It has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. It may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes.

Patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery.

This study will allow for comparison in knee function and patient outcomes between patients who have undergone their TKR with patient specific cutting blocks compared to conventional cutting blocks. The scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon

Exclusion Criteria:

* Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity \> 5 degrees
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.

The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age 18-40 years
* Informed consent and willingness in study participation
* Birth control during study period

Exclusion Criteria:

* Participation in other clinical trials
* Contraindication or known allergy to study medication
* Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others
* Known alcohol or nicotine abuse
* HIV infection
* History of pharmaceutical study in the last 4 weeks
* BMI \< 18 \> 25
* Long-term or regular medication
* Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder
* Dependence to study center or coordinator
* Inmates or psychiatric treatment
Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men

When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 60 to 80 years old
* Non-smoker
* Generally healthy and can tolerate the resistance exercise and protein drink

Exclusion Criteria:

* Allergies to whey, casein or soy
* Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
* Failed clearance for exercise participation by their medical doctor
* Failed an exercise stress test
* Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
* Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
* Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
Impact of Pillboxes on Medical Adherence

This study uses an experimental design to test the impact of different types of pillboxes on medication adherence. Participants in this study will randomized to receive one of the three pillbox interventions: 1) A standard seven day a week, one-dose per day pillbox with training 2) an off-the-shelf pillbox that was purchased specifically for the individual's needs with training and education, or 3) a customized 3D printed pillbox that was designed and manufactured specifically to the individual's needs with training and education. Participants will have three visits with the research team to collect baseline data, receive the pillbox, and collect follow up data.

Risks to the study include loss of time, boredom, invasion of privacy, and medication errors. The investigators have taken precautions to mitigate these risks. This study will improve understanding of medication adherence and potentially help us better address poor medication adherence which needlessly causes morbidity, mortality, and costs over $300 million in unnecessary healthcare costs each year.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* speak English
* be prescribed to take two or more medications per day, and manage their own medications.

Exclusion Criteria:

* have a significant cognitive impairment
* unwilling to use a novel pillbox
* unable to meet with the research team
Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≤19 years.
* Those who voluntarily signed the informed consent to participate in this study.
* A patient diagnosed with essential hypertension or Patients taking hypertension medication
* Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg

Exclusion Criteria:

* At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg
* Secondary hypertension patients or those with a history of suspected secondary hypertension
* Cardiovascular/cerebrovascular disease
* Those with a history of malignant tumor within 5 years