cyrilzakka/clinical-trials huggingface dataset:
Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome

Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (\> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure.

The aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.


Eligibility Criteria:
Inclusion Criteria:

* Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome

Exclusion Criteria:

* • age \<18 yr;

  * pregnancy or estro-progestinic therapy;
  * tracheostomy;
  * neurological or neuromuscular pathology and/or known phrenic nerve dysfunction;
  * previously diagnosed intrinsic thyroid disease; known or suspected pituitary-hypothalamic disease;
  * severe obesity;
  * ischemic cardiopathy; complex ventricular arrhythmias;
  * serum cortisol level below 80 ng/ml; renal or hepatic failure (respectively, creatininemia ≥ 3.5 mg/dL and bilirubinemia ≥ 6.0 mg/dL);
  * transfusion of plasma within 48 h prior to thyroid hormone assessment; use of amiodarone in the previous 8 weeks;
  * use of iodine contrast agents in the previous 8 weeks;
  * hemodialysis;
  * expected poor outcomes
Genetic Variants and Phenotypic Characteristics of Patients With T2DM

Background: Genetic risk-markers associated with T2DM are thoroughly studied. So far, only a few genetic variants, also termed single nucleotide polymorphisms (SNP's), have been replicated in several studies and each of them gives only limited explanation for the growing incidence of T2DM. The hypothesis of the present study is that determination of combinations of genetic variants by SNP-chip technology may improve the prediction of T2DM, complications and efficacy of treatment compared to the methods previously used including genome wide association (GWA) studies. The SNP-chip/ DNA microarray makes it possible to study several SNP's association with T2DM, one by one but also in combination.

Aims: To study whether specific genetic variants, and combinations of these, 1) are present with higher prevalence in patients with T2DM than in the normal population, 2) are associated with specific diabetes-related complications and 3) the effect of the anti-diabetic treatment.

Methods: During the next three years 1000 patients with T2DM and 1000 healthy, non-diabetic persons will be included in the study, and examined by blood samples, a questionnaire and clinical evaluation, all in one visit. Initially, we will perform DNA analyses on blood samples from 372 patients included in another clinical study from our department. Description of genetics will be done by a DNA-chip with approximately 70 SNP's, which have previously been reported to be associated with T2DM.

Results and conclusions: It is expected that the result of this project can help us predicting T2DM, diabetes-related complications and individualizing treatment to the individual patient with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* \> 18 years and
M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia

This study intends to evaluate the efficiency and safety of M-PTCy as conditioning regimen in Haploidentical HSCT for Acute Leukemia, so as to provide a new conditioning regimen for allogeneic hematopoietic cell transplantation.

Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Posttransplant cyclophosphamide (PTCy) has revolutionized Haplo HCT with acceptable rates of engraftment, graft-versus-host disease (GVHD), relapse, and survival.To prolonger PFS, OS and alleviate GVHD, we combined Mitoxantrone liposomes with PTCy as conditioning regimen in allogeneic hematopoietic cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. The patients meet the diagnostic criteria for acute leukemia(except APL).
2. Expecting life span is more than 3 months.
3. The patients intended allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

1. Previously received doxorubicin or other anthracycline therapy, the total cumulative dose of doxorubicin≥360 mg/m2.
2. Cardiac function and disease meet one of the following conditions:

   1. Long QTc syndrome or QTc intervalgt≥480 ms;
   2. Complete left bundle branch block, grade II or III Degree atrioventricular block;
   3. Severe, uncontrolled arrhythmia requiring drug treatment;
   4. New York Society of Cardiology class ≥ II;
   5. Cardiac ejection fraction (LVEF) lower than 50% or lower than the study The lower limit of the central laboratory test value range;
   6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically serious pericardial disease history within 6 months before recruitment, or ECG evidence of acute ischemia or active conduction system abnormalities.
3. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \> 2.5 times the upper limit of normal (ULN); Total bilirubin \> 1.5 times upper limit of normal; Serum creatinine \> 1.5 times the upper limit of normal.
4. Suffering from other malignant tumors in the past or at the same time ;
5. Exclude patients with severe active infection or other underlying diseases who cannot tolerate chemotherapy;
6. Human immunodeficiency virus (HIV) infected patients (HIV antibody positive);
7. Active hepatitis B and C infection；
8. Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study;
9. Severe mental disorders who do not cooperate with treatment;
10. Judgment by the investigator , There are patients who are not suitable to participate in this study.
Clinical Outcomes in HIV With Comorbidities

Multi-arm, non-randomized, quality of life

This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.

Eligibility Criteria:
Inclusion Criteria:

1. HIV antibody positive
2. Age above 18 years
3. Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
4. Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor

Exclusion Criteria:

1. Recent diagnosis of AIDS within 6 months
2. Recent hospitalization for management of acute medical problems within 6 months
3. Receiving ART regimens other than the combinations listed in Inclusion Criteria
Formative Research to Develop an Intervention Package to Promote Practice of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community (CKMC)

The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.


Eligibility Criteria:
Inclusion Criteria:

* Low birth weight or preterm newborns

Exclusion Criteria:

* Babies with hospitalization criteria
* unable to feed or weight less than 1500 grams at birth
Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children

This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation of gastric and duodenal motility in children. The ADM studies will be done for clinical purposes and only if recommended by the patient's gastroenterologist. The research portion of the study is limited to the use of SmartPill.

ADM is a standard procedures used in children, but it has some limitations and disadvantages. Manometry studies involve placing catheters in the nose and are often poorly tolerated by children. Also, placement of the catheter requires sedation or anesthesia, the manometry test lasts several hours and involves ingestion of a meal which many children find difficult when having a catheter in their nose. The reason we are conducting this study is because we would like to find a new, less invasive, equally informative test for understanding gastrointestinal motility.

The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the capsule measures the acidity (pH) and pressures, and these measurements are used to determine how long it takes for food to leave the stomach. Pressure and pH information are sent by the capsule to a receiver that the patient will either wear on the belt or keep within 2 feet. The receiver stores data collected about the pH, temperature, and pressure inside the GI tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug Administration (FDA) for use in adults but not in children.

Eligibility Criteria:
Inclusion Criteria:

* Children older than 10 years of age referred to our Motility Center to receive AD manometry studies will be offered participation to the study
* The patients will have to be able to swallow the SmartPill capsule
* The patients will need to have no evidence of strictures or narrowing

Exclusion Criteria:

* Inability to swallow the capsule
* Patients on TPN because of inability to tolerate enteral feedings (high likelihood of not emptying the capsule from the stomach)
* Children with evidence of strictures
* Children with history of esophageal or gastric surgeries, such as TE fistula, fundoplication, or gastrojejunostomy
* Children with a history of gastric bezoars
* Allergies to components of the test meal including eggs, bread, and jam
* Patients with history of inflammatory bowel disease
Prevalence and Impact on Quality of Life of Lower Urinary Tract Symptoms (LUTS) in Night Workers

The first large population-based study to evaluate lower urinary tract symptoms and their impact on quality of life in night workers.

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) and their impact on quality of life in night workers. The study objective is to assess the prevalence and bother of LUTS in the population of night workers.

This study will be conducted as a questionnaire survey with assessment of LUTS using a standardized protocol based on definitions by the International Continence Society (ICS). The International Prostate Symptom Score (IPSS), the Overactive Bladder- Validated 8-question Screener (OAB-V8), the Patient Health Questionnaire-9 (PHQ-9), the Athen Insomnia Scale, the Work Productivity and Activity Impairment Questionnaire (WPAI), the 12-Item Short Form Health Survey (SF-12) questionnaires will be included. Participants will be also asked to rate how often they experienced individual LUTS and the degree of associated bother.

Eligibility Criteria:
Inclusion Criteria:

Night workers defined as any workers, who, during night time, work at least three hours of their daily working time as a normal course or who work at night at least 1/4 of their working time during the accounting period (definition by the Polish Labour Code).

Exclusion Criteria:

Non night workers Urinary tract infection in the past 4 weeks
Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.

Postoperative disturbances for patients' well-being in the PACU after general or spinal anaesthesia will be assessed. Influence of the offer of beverages and music will be assessed regarding their wellbeing, satisfaction and pain.


Eligibility Criteria:
Inclusion Criteria:

* elective stationary adult patients capable and willing of filling out the questionnaire

Exclusion Criteria:

* participation in other studies about wellbeing influence
* incapability of filling out the questionnaire
* patients that do not wish to participate
Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction

The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy
* American Society of Anesthesiology (ASA) Physical Status I-III
* BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea

Exclusion Criteria:

* Inpatient status
* Active Congestive Heart Failure Exacerbation
* Untreated ischemic heart disease
* Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
* Emergent procedures
* Pregnancy
* Previous enrollment in this study
* Inability to provide informed consent
* Additional medical testing planned for the same day
* History of allergic reaction to Propofol
* Tracheostomy
* Supra-glottic or sub-glottic tumor
* Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
* Prisoners
* Unable to fit SuperNoVa
Counseling for Primary Care Office-based Buprenorphine

The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.

To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.

Eligibility Criteria:
Inclusion Criteria:

* opioid dependence

Exclusion Criteria:

* current dependence on alcohol, cocaine, benzodiazepines or sedatives
* current suicide or homicide risk
* current psychotic disorder or untreated major depression
* inability to read or understand English
* life-threatening or unstable medical problems
A Study to Evaluate the Safety and Efficacy of GR2002 Injection in Patients With Atopic Dermatitis.

This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.


Eligibility Criteria:
Main Inclusion Criteria:

1. Patients need to meet Williams diagnostic criteria, have had AD for at least 1 year, and:EASI ≥16, IGA score ≥3, and AD involvement of ≥10% of BSA;
2. Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD;
3. Voluntary informed consent.

Main Exclusion Criteria:

1. Current malignancy or history of malignancy;
2. History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
3. Subjects may have active Mycobacterium tuberculosis infection;
4. Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit;
5. History of known or suspected immunosuppression;
6. Presence of skin comorbidities that may interfere with evaluation;
7. Suspected or confirmed allergy to the test drug (including excipients, similar drugs);
8. History of alcohol or drug abuse within 3 months prior to screening；
9. Pregnant or lactating women who need to breastfeed；
10. Major surgery planned during the trial；
11. The elution cycle of the drug of interest is not met at the baseline；
12. Subjects of childbearing potential and partners refusing to use highly effective contraception.
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears

The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.


Eligibility Criteria:
Inclusion Criteria:

* bursal side rotator cuff tears in MRI sections
* Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months
* 25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side

Exclusion Criteria:

* Previous surgery
* tears greater than 50% or 6 mm
Applying Proton Pump Inhibitor to Prevent and Treat Acute Fluctuating Hearing Loss in Patients With SLC26A4 Mutation

Disequilibrium between acid and base in the inner ear was suggested to be an important factor leading to hearing impairment associated with SLC26A4 mutations. For acid-base homeostasis in the inner ear, gastric-type proton pumps might demonstrate antagonistic effects to pendrin, the protein encoded by SLC26A4. To investigate whether proton pump inhibitors might prevent or treat acute fluctuating hearing loss related to SLC26A4 mutations, we launch the current double-blind randomized clinical trial.

Hereditary hearing loss is the most common inherited sensory defect, affecting about 1 per 1000 children. With the advances in molecular genetics, the nature of hereditary hearing loss has started to be unraveled. A plethora of deafness genes were discovered in the past years, and among them certain genetic mutations were noted to be extraordinarily popular in the hearing-impaired population. For example, mutations in the SLC26A4 gene have been documented with high prevalence in a variety of ethnic backgrounds, including Caucasians, Japanese and Han Chinese.

The two specific clinical features of patients with SLC26A4 mutations are inner ear malformations and fluctuating hearing loss. For decades, the latter has constituted a treatment difficulty for pediatric otologists, because traditional regimens, such as steroid or intracranial-pressure-lowering-medication, usually could not achieve satisfactory and predictable outcomes. Nevertheless, as basic researches in recent years began to shed light on the pathogenesis of hearing loss from SLC26A4 mutations, novel strategies could be developed based on some of these crucial findings. For instance, disequilibrium between acid and base in the inner ear was reported to be an important factor leading to deafness in SLC26A4 knock-out mice. And for acid-base homeostasis in the inner ear, proton pumps were found to demonstrate antagonistic effects to pendrin, the protein encoded by SLC26A4. Consequently, regimens which can modulate the function of proton pumps, like proton pump inhibitors, might be a good choice to prevent or treat acute or chronic hearing loss related to SLC26A4 mutations or degenerative dysfunction.

Corresponding to this postulation, clinically we experienced significant recovery of hearing loss in several patients with SLC26A4 mutations who suffered from acute fluctuating hearing loss which was refractory to traditional treatment. In some cases, acute hearing loss recurred after the medication was discontinued. Therefore, we launch the current clinical trial to investigate the efficacy of proton pump inhibitor in preventing and treating acute hearing loss in patients with SLC26A4 mutations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with homozygous or heterozygous SLC26A4 mutations
* Patients with acute hearing loss

Exclusion Criteria:

* Patients who do not fulfill both of the above criteria