cyrilzakka/clinical-trials huggingface dataset:
Interventions to Improve Non-communicable Disease Management During the Pandemic

This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. The main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective.

30 rural health centers in Punjab Province, Pakistan will be randomized into two groups. The intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of NCDs during the pandemic, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Usual care will be provided in the control group. Researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 10 months.


Eligibility Criteria:
Inclusion Criteria:

* Reside in the catchment of selected rural health centers;
* Provide informed consent;
* Newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmHg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmHg;
* Have a smartphone or can access a smartphone from a relative.

Exclusion Criteria:

* Patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.
L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia

Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns \< 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns \<32 WG with THOP is beneficial.

The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.

Preterm newborns \<32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of life. THOP is defined by thyroid-stimulating hormone (TSH) \< 20 mIU/L and FT4 \< 0.80 ng/dL. After obtaining written consent from the parents, preterm newborns \<32 WG with THOP will be included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed 2 weeks after stopping treatment.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 32 WG
* FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL
* TSH (5, 6 or 7 days of life) \< 20 mIU/L
* Written consent from the parents

Exclusion Criteria:

* Maternal thyroid disease
* FT4 (5, 6 or 7 days of life) \> 0.8 ng/dL
* TSH (5, 6 or 7 days of life) \> 20 mIU/L
* Grade III or IV intracerebral hemorrhage
Sugammadex-dosing in Bariatric Patients

Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?

The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent

The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC \< 5)


Eligibility Criteria:
Inclusion Criteria:

adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information

Exclusion Criteria:

not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis.

The main questions it aims to answer are:

* What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact?
* What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy?

Participants will be randomized to one of two study arms:

* Tapering based on disease-activity guided dose reduction (experimental arm)
* Tapering based on interval prolongation (active comparator arm)


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent and participate in the study before any study procedure.
* Age ≥ 18 years.
* Understanding and able to write in Dutch or French.
* Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for rheumatoid arthritis.
* Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab).
* Current treatment with rituximab.
* Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score ≥3.2).
* Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.

Exclusion Criteria:

* Current treatment with another biological DMARD than rituximab.
* Current treatment with a targeted synthetic DMARD.
* Pregnancy or pregnancy wish.
* Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.
Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain

Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.

The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.

The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.

Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for surgery of intracerebral tumors in the study group.
* Hospitalized for a biopsy of intracerebral tumor lesion in the control group.

Exclusion Criteria:

* Age \<18 years
* Enucleation Prohibited to the achievement of an ocular ultrasound
* Hypersensitivity to gel
* Eye Wound
* Massive facial fracture
* Skin Infection Site
Using a New Human Milk Fortifier to Optimize Feeding

This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.

Infants with fortified human milk feeding have the same rate of growth, lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization. However, the currently human milk fortifiers (HMF) have some nutritional components defects to meet the needs of very preterm infants. New HMF provide higher protein and fat, which are safe and well tolerate to use in preterm infants. Study on safety and efficacy of the new HMF is insufficient in Chinese preterm infant population. Our aims are to compare the safety and efficacy of a new HMF and other HMF used before in very preterm infants. Very low preterm infants with birth weights of 1000-1499g and gestational age 28+0 weeks to 31 + 6 weeks are included. Infants feeding with new HMF are in the experimental group. Infants feeding with other HMF are in the control group, a historically control group. Physical growth, nutritional indexes, incidence of feeding intolerance, and time to achieve full enteral feeding are compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Infants with gestational age between 28+0 weeks to 31+6 weeks, and 1000g≤ birth weight\<1500g;
* Delivered in the study centers or transfer to the study centers within 24 hours after birth;
* Own mother's milk or human milk bank were available;
* Only one of the twins is selected in this study;
* Informed consent has been obtained.

Exclusion Criteria:

* Severe congenital malformations, severe asphyxia, intracranial hemorrhage and other diseases;
* Small for gestational age infants (birth weight below the 10th percentile of the reference, Fenton premature infant growth chart (2013)）;
* Enteral feeding is not tolerated in 14 days after birth;
* Infants who have participated in other clinical trials within 1 month;
* Other conditions not suitable for this study.
Subjective and Objective Refraction in Pseudophakic Patients

Targeting of post-cataract refraction depends mainly on the prediction of the post-operative lens position, but also on the post-operative refraction itself. Hence, aim of this study is to evaluate the agreement and variability of subjective refraction performed by two independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients after uneventful cataract surgery.

One of the main goals of modern cataract surgery, beside removing the cataractous lens, is to achieve the patient's desired post-operative refraction. Targeting this post-operative refraction depends mainly on the prediction of the post-operative lens position and the post-operative refraction itself. Reason for the contributing effect of post-operative refraction in the error-propagation analyses is that refraction in phakic patients was shown to have only moderate reproducibility.

In the past, different studies evaluated refraction methods. However, there is no study that included reproducibility of subjective refraction in pseudophakic patients and compares it with objective refraction methods (autorefraction, wavefront aberrometry).

100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in the study. Refraction of one eye of each patient will be tested using subjective refraction by two different examiners, autorefraction, and wavefront aberrometry at two separate occasions.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 21 years
* Cataract surgery (at least 8 weeks post-surgery)
* written informed consent

Exclusion Criteria:

* Complications during or after cataract surgery
* Ophthalmic diseases, that might interfere with measurements (macular degeneration, glaucoma, diabetic retinopathia)
* Ophthalmic surgery other than cataract surgery
* Clinically significant posterior capsule opacification
AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol

The woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy.

Until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve.

Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed.

The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro Fertilization protocol.


Eligibility Criteria:
Inclusion Criteria:

* All infertile patients aged between 18 and 43 years
* Patients with a prescription for a stimulated In-Vitro Fertilization cycle

Exclusion Criteria:

* Presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (TSH) or Cushing syndrome
* Renal or hepatic impairment known
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant who gave written informed consent to participate in the study in accordance with local regulations.
* Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
* Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
* At the Screening Visit, A1C was between 7.0% to 11.0%.
* Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained chronic cough.


Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or computed tomography scan of the thorax not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
* Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough.
* Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, and needs further treatment.
* If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance.

Exclusion Criteria:

* Current smoker, or has given up smoking within 12 months of Screening.
* History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status.
* Has a history of chronic bronchitis.
* Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening.
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 OR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1).
* History of malignancy ≤ 5 years.
* User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
* Systolic blood pressure \>160 mm Hg or a diastolic blood pressure \>90 mm Hg at Screening.
* History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.
* Known allergy/sensitivity or contraindication to gefapixant.
* Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant.
* Previously received gefapixant or is currently participating in or has participated in an interventional clinical study.
Dismantling the Components and Dosing of CBT for Co-Occurring Disorders

The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
* inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
* alcohol use in the 30 days preceding the study
* ability to provide informed consent
* minimum of a sixth grade reading level (deemed necessary to complete study materials);
* willingness to provide contact information to confirm study follow-up appointments
* lives within proximity to the Twin Cities (e.g., within about an hour's drive) for the purpose attending follow-up visits

Exclusion Criteria:

* lifetime history of psychosis or mania by history
* cognitive or physical impairment that precludes study participation
* currently and seriously suicidal (i.e., plan and intent)
Computer Assisted Early Detection of Liver Metastases From fMRI Maps

The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps enabling early detection of colorectal metastases in the liver.

In this research, we propose to develop methods and protocols for imaging-based, non-invasive early detection and diagnosis of colon cancer metastases. Colon cancer is the third most common cancer worldwide. While it is amenable to surgery if detected early, advanced carcinomas are usually lethal, with liver metastases being the most common cause of death. Early and accurate detection of these lesions is recognized as having the potential of improving survival rates and reducing treatment morbidity. Current diagnostic imaging offers improved discrimination and sensitivity that can be used for earlier detection of smaller lesions conducive to curative therapy.

In previous research, we demonstrated the feasibility of fMRI based on hypercapnia and hyperoxia for monitoring changes in liver perfusion and hemodynamics without contrast agent administration. The isolation and analysis of areas with significant hemodynamical changes in images acquired at early phase of tumor development has proven to be a difficult, time consuming, and potentially unreliable task. Our goal is thus two-fold: 1. use image processing and machine learning tools on a training set of hemodynamical maps obtained from well validated tumors to automate the process and improve its discrimination and sensitivity characteristics, and; 2. implement our method in patients with colorectal liver metastases. The method can help general radiologists with no image processing training to highlight undetectable tumors from background noise and increase diagnosis specificity and sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Control group of healthy volunteers
* Study group: Patients with colon cancer stage III or IV with high suspicion of liver metastases: raising CEA, suspected lesion in the liver by CT or PET.

Exclusion Criteria:

* Contraindication to perform MRI.