cyrilzakka/clinical-trials huggingface dataset:
Low Carb vs Normal Carb in Pregnancy

The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old
* BMI \> 30 and/or history of gestational diabetes mellitus
* Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
* Newborns of current participants

Exclusion Criteria:

* Diabetes (types 1 and 2)
* History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
* Known fetal anomaly
* History of eating disorders
* Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
* Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco
Headache Inducing Effect of Cromakalim in Migraine Patients

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.


Eligibility Criteria:
Inclusion Criteria:

* Migraine patients of both sexes.
* 18-60 years.
* 50-90 kg.
* Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind other than oral contraceptives
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
Predictors of Rejection in Pediatric Kidney Transplantation

Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft

The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .

Eligibility Criteria:
Inclusion Criteria:

1. Paediatric living donor kidney transplant recipients (aged 1-18 years)
2. patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (MMF) and steroids
3. recipients with biopsy proven acute rejection in the studied group.

Exclusion Criteria:

1. patients on cyclosporine
2. patients with active infection and dehydration
3. Patients who received multiorgan transplantation Non cooperative patient will be excluded
Effect of Occupational Therapy in Promoting Medication Adherence

The purpose of this research study is to see if an occupational therapist can help people with high blood pressure and/or diabetes find ways to better take their medicine. Participants will be recruited from the Jordan Valley Community Health Center in Springfield, Missouri.

The purpose of this study is to determine whether the addition of an occupational therapy intervention to counseling by a clinical pharmacist (current usual care) compared to counseling by a clinical pharmacist only, will affect three-month medication adherence rates among community-dwelling adults with uncontrolled hypertension and/or diabetes.

To meet this purpose, the following objectives will be addressed:

1. to determine if the addition of the delivery of an occupational therapy intervention (specifically the Integrative Self-Management Intervention) to usual care improves three-month medication adherence rates, as measured by the Adherence to Refills and Medication Scale (ARMS-7), pill count, blood pressure and/or hemoglobin A1c.
2. to determine whether the administration of the occupational therapy intervention in addition to usual care influences an individual's readiness for change as measured by the stages of change measure; and
3. to explore whether participant demographics (e.g., gender, age, race/ethnicity, assist at home, co-morbidities, and number of medications) impact three-month medication adherence rates.

Eligibility Criteria:
Inclusion Criteria:

* Jordan Valley Community Health Center clients will be considered eligible for inclusion in the study if they are 18 years or older, have a confirmed diagnosis of hypertension, receive a score of less than or equal to 21 on the Adherence to Refills and Medication Scale (ARMS-7) and they provide written informed consent.

Exclusion Criteria:

* Participants will be excluded if they indicate via self-report that they are unable to read or understand spoken English without an interpreter or translator or if they have a medical power of attorney and are unable to provide their own informed consent.
Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function

Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions.

This study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1\~2,scheduled to undergo upper abdominal surgery by midline incision

Exclusion Criteria:

* neuromuscular disorder
* history of malignant hyperthemia
* allergy to medications used during general anesthesia
Ultrasound Prediction of Prolonged Labour

This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.

AIM:

To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.

Objective:

Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.

In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.

Methods:

A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.

The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.

The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.

Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.

Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.

Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.

Eligibility Criteria:
Inclusion Criteria:

* Primi gravidae
* \>37th week
* Cephalic presentation
* Prolonged first stage according to WHO definitions.

Exclusion Criteria:

* Multiple pregnancies
* Intrauterine fetal death
Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy

The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique for postoperative analgesia. Investigators are comparing between patient re-education and the background morphine infusion among patients who fail to achieve satisfactory analgesia using IV-PCA Morphine after laparotomy.

In this study, investigators have a second inclusion criteria for subject recruitment. For subjects who meet this criteria meaning their dynamic pain (when blowing incentive spirometer) is ≥ 4/10 after starting on IV-PCA Morphine will be randomized in to 2 groups. One group will receive patient re--education with an additional background morphine infusion and the other group will receive re--education only.

The second highlight for this study is regarding the background morphine calculation. The background morphine is calculated according to this formula:

Total morphine requirement in the first 24 hours post surgery (mg) = 100 - Age (year) So, the background morphine infusion will be calculated based on subject's age and half of their 24 hours requirement will be infused over 24 hours.

This formula was published by Pamela Macintyre in her paper titled " Age is the Best Predictor of Postoperative Morphine Requirement".

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA)Physical Status Classification Class I and II
* Elective laparotomy
* able to understand either malaysia, mandarin, english language or local dialect
* patient with dynamic pain score 4/10 and more within the first 4-hour after initiation of IV-PCA

Exclusion Criteria:

* patient refusal
* laparotomy with pfannenstiel incision
* patients with a history of allergy to opioids
* patients who required post-operative ventilation support
* patients ASA III and above
* patients unable to use PCA due to insufficient comprehension
* morbid obesity/ obstructive sleep apnea
* chronic opioid or alcohol abuse
Speech Locator In-car Performance Evaluation

Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N5 (severe) by 10 dB
Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

This study evaluates the efficacy of PGx-guided medication in patients with depression treated with Venlafaxine and the efficacy of the combination of PGx and TDM in patients with depression treated with Venlafaxine. Half of participants will receive PGx-guided treatment, while the other half will receive routine treatment. After the 8th week, the PGx-guided treatment group would be randomly divided into two groups. Of which, half of participants will receive the combination of PGx and TDM, and the other half will receive PGx -guided medication only.

The current clinical medication is based on "Trial and Error", while the traditional medication is mainly based on experience. The study mainly optimizes the treatment path from two perspectives: to help clinicians select drugs accurately through the detection of PGx; to help clinicians monitor the whole process of drug use through TDM and adjust the dosage in time to achieve better treatment.

PGx tests take the information of metabolic, transporting and target genetic factors into account comprehensively. Furthermore, clinical effects depend on blood concentration rather than dose concentration. TDM aims to monitor blood concentration, which is related to drug efficacy and toxicity.

Venlafaxine is an antidepressant drugs of the 5-hydroxytryptamine selective seratonin re-uptake inhibitors (SSRIs), which has been approved by FDA for the treatment of depressive disorders, depressive disorders with anxiety symptoms, generalized anxiety disorders and social anxiety disorders since 1994.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endogenous depression, with any of the following 4 symptoms: ① Interest Loss; ② Hypothymia; ③ Early awakening; ④ Serious in the morning and relieved at night; ⑤ Hysteresis or agitation of movement of Spirit; ⑥ Appetite loss; ⑦ Weight loss; ⑧ Loss of libido;
* Scores of 17 items in Hamilton Depression Scale (HAM-D17): over 17 points;
* First-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months;
* No significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen).
* No obvious abnormalities in laboratory examination (Thyroid Function).
* Informed patient consent.

Exclusion Criteria:

* Those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders;
* Patients with stroke, brain tumor and other brain organic diseases;
* Patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as Eszopiclone, alprazolam or estazolam);
* History of drug allergy;
* Pregnant and lying-in women;
* Patients with serious suicidal tendencies.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc). The study consists of two parts - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).


Eligibility Criteria:
Inclusion Criteria:

* More than or equal to (≥)18 years of age
* Eastern cooperative oncology group (ECOG) class 0-2
* Life expectancy of a minimum of 3 month
* Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options.

Exclusion Criteria:

* Participant has not recovered (i.e., to Grade less than or equal to \[≤1\] or to baseline) from prior chemotherapy-induced AEs.
* Participant is currently participating in a treatment study or has participated in a study of any investigational agent within 4 weeks of the first dose of treatment.
* Participant has symptomatic uncontrolled brain or leptomeningeal metastases.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years
* Participant has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
* Participant has uncontrolled hypertension with sustained systolic blood pressure (BP) \>140 millimetres of mercury (mmHg) or diastolic BP \>90 mmHg.
Comparative Study of Secondary Prophylaxis for SBP

The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:

Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?

What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?

Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.

Participants will:

Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).

Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.

Be monitored for any side effects and recurrence of SBP.


Eligibility Criteria:
Inclusion Criteria:

Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.

* Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.
* Ascitic fluid polymorphonuclear (PMN) cell count \> 250/mm³.
* Age 50 years to 80 years.
* Willing to provide informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding females.
* History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.
* Patients with recurrent spontaneous peritonitis.
* Presence of gastrointestinal hemorrhage.
* Renal failure (Creatinine \> 2 mg/dL or on dialysis).
* Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).
The Effect of Motivational Interviewing on Diabetes Self-Management and Severity of Cyberchondria in Individuals With Diabetes

Objective: The aim of this study was to determine the effects of diabetes education given to individuals with diabetes using motivational interviewing technique based on the health promotion model on diabetes self-management and cyberchondria severity. Materials and Method: The population of the study consisted of 1000 individuals. The sample consisted of 64 individuals, 32 experimental and 32 control, who met the research criteria. The research will be conducted between 15.02.2025-15.03.2025 in Van Regional Training and Research Hospital Diabetes outpatient clinic. Data in the research; Descriptive Information Form, Diabetes Self-Management Scale (DMS), Cyberchondria Severity Scale-Short Form (CSS-SF) scales will be applied. Research experiment Motivational interviewing intervention based on the health belief model will be conducted once a week for 1 month. At the end of 1 month, both scales will be administered again to individuals in both experimental and control groups.

Objective: The aim of this study is to determine the effects of diabetes education given to individuals with diabetes using motivational interviewing technique based on the health promotion model on diabetes self-management and cyberchondria severity. Material and Method: The population of the study consisted of 1000 individuals. The sample consisted of 64 individuals, 32 experimental and 32 control, who met the research criteria. The research will be conducted in Van Regional Training and Research Hospital Diabetes outpatient clinic between 15.02.2025-15.03.2025. Data in the study; Descriptive Information Form, Diabetes Self-Management Scale (DMSS), Cyberchondria Severity Scale-Short Form (CSS-SF) scales will be applied. Research experiment The motivational interviewing intervention based on the health belief model will be conducted once a week for 1 month. At the end of 1 month, both The scales will be administered again to the individuals in both the experimental group and the control group. Descriptive statistical methods (number, percentage), chi-square test, independent t-test in groups and paired t-test will be used.

Eligibility Criteria:
Inclusion Criteria:

* Having diabetes for at least 6 months
* Being over 18 years old
* To have sufficient communication skills to answer verbal and written questions and fulfill instructions
* Being literate
* No physical, cognitive or mental impairment in answering the questions
* Willingness to participate in research.

Exclusion Criteria:

* Being under 18 years of age
* Being hospitalized in inpatient treatment institutions due to DM or DM complications during the research process
* The emergence of any health problem that prevents the person from continuing the research
* Do not leave the study voluntarily.
Safety of Autologous Cord Blood Cells for Preterm Infants.

To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.

Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).

Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.

Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants \<37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.

Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively.

Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.

Eligibility Criteria:
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: \<37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.