cyrilzakka/clinical-trials huggingface dataset:
Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes

Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

1. Tendency to participate
2. Age range of 40-65
3. Suffering from diabetes type 2 ( between 1 to 10 yeares)
4. BMI 18/5-30
5. Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

1. patients with liver diseases
2. patients with kidney diseases
3. patients with inflammatory diseases
4. patients with liver diseases
5. Administering herbal agents
6. Administering multivitamins and minerals in past 3 months
Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion

RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known.

PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.

PROTOCOL OUTLINE: Patients are assigned to one of 6 study groups.

Patients receive infusions of stable isotope tracers: \[15N\]urea IV beginning at -12 hours and continuing over 22 hours to measure protein oxidation; \[U-13C\]glucose IV beginning at zero hour and continuing over 10 hours to measure glucose appearance rate and gluconeogenesis; \[2-13C\]glycerol IV over 10 hours to measure lipolysis; and \[1-C\]leucine IV over 10 hours to measure proteolysis. Blood samples are obtained before the start of the urea tracer infusion; before the start of the glucose, glycerol, and leucine tracer infusions; and at study hours 4, 4.5, 5, 9, 9.5, and 10. Blood glucose is measured hourly, and patients receive glucose IV if blood glucose falls below 40 mg/dL.

Group I: Patients are randomized to one of two study arms. Arm I: Patients receive standard total parenteral nutrition (TPN), except the \[U-13C\]glucose is substituted for a portion of the glucose. Arm II: The infusions of lipids (Intralipid) and amino acids (TrophAmine) are discontinued at study hour zero. The infusion rate of natural glucose will be reduced during the first hour, and thereafter discontinued.

Group II: Patients are randomized to receive either TrophAmine or Intralipid IV over the last 5 hours of the study.

Group III: Patients are randomized to receive one of two different doses of glycerol IV over the last 5 hours of the study.

Group IV: Patients are randomized to receive either glutamine or alanine IV over the last 5 hours of the study.

Group V: Patients receive glucagon IV for 24 hours prior to study. Patients are then randomized to receive glucagon IV with either IV glucose alone or with Intralipid and TrophAmine IV.

Group VI: Patients who are hyperglycemic receive TPN and \[U-13C\]glucose as in group I, arm I, over 14 hours, and regular insulin IV at 10 hours, followed by an IV infusion of carbohydrate. Blood samples obtained between hours 4 and 5 are omitted, and are drawn instead between hours 13 and 14.

Eligibility Criteria:
* Clinically stable, very low birth weight infants (750-1,500 grams)
* Normal blood glucose values OR Blood glucose greater than 175 mg/dL
* No prior insulin
* No sepsis Oxygen supply less than 30% Normal acid base status
* No malformation
* No discernible diseases
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
2. Female patients with menopausal status:

   i. Postmenopausal status defined as meeting at least one of the following criteria:
   1. Have undergone a bilateral oophorectomy any time in life;
   2. Age ≥60 years, or
   3. Age \<60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value \>40 milli-international units per milliliter (mIU/mL) and an estradiol value \<40 picograms per milliliter (pg/mL) (140 picomoles per liter \[pmol/L\]).

   ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH agonist during the study.
3. Patients meeting all the following criteria:

   1. Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;
   2. Limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease
   3. Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.
   4. For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.

Exclusion Criteria:

1. Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
2. Participants with prior anticancer or investigational drug treatment within the following windows are excluded:

   1. Any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment.
   2. Any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.

   * Other protocol defined inclusion/exclusion criteria could apply
Repetitive Split-Belt Treadmill Perturbation in Children With Unilateral Cerebral Palsy

This study was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Fifty-two children with ULCP were randomly allocated to the split-belt treadmill walking (n = 26; undergone split-elt treadmill training or the Control group (n =23, received standard rehabilitation program). Both groups were assessed for gait symmetry, dynamic balance control, and locomotor capacity pre and post-treatment.

Fifty-two children with ULCP were recruited from the Physical Therapy Outpatient Clinic of the College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 10 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems that could be exacerbated by exercise.

Outcome measures

1. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.
2. Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
3. Locomotor capacity: This was assessed through the 6-minute walk test (6-MWT), the Timed Up and Down Stair test (TUDS), and the 10-meter Shuttle Run Test (10mSRT).

Both groups were trained for one hour, three times a week, for 12 successive weeks. The split-belt treadmill walking group performed repetitive split-belt treadmill training with an error-augmentation strategy (i.e., exaggeration of the initial step-length asymmetry). The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral cerebral palsy
* Age 10-16 years
* Motor function level I or II according to the Gross Motor Function Classification System.
* Spasticity level 1 or 1+ according to the Modified Ashworth Scale

Exclusion Criteria:

* Structural deformities/contractures
* Musculoskeletal or neural surgery in the last year
* BOTOX injection in the last 6 months.
* Cardiopulmonary disorders that could be exacerbated by exercise.
* Perceptual and/or behavioral disorders.
Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence

Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is unclear how and when it effects the bone density. The investigators are studying the effects of diabetes on bone mass compared to children without diabetes.


Eligibility Criteria:
Inclusion Criteria:

* We will recruit children from age 5 to age 18 with a diagnosis of Type 1 DM. Children will have various lengths of time since diagnosis.

Exclusion Criteria:

* We will exclude children on anticonvulsants or steroids and children with other concomitant illnesses that interfere with bone mass accrual, except for hypothyroidism on treatment.
UMIT-1 Trial Favipiravir & Ribavirin for the Treatment of CCHF

UMIT-1: A Randomised Phase Ib Study to Determine the Phase II dose and to Evaluate the Safety and Efficacy of intravenous (IV) Favipiravir \& Ribavirin for the Treatment of CCHF

This will be a 2:1 randomised open-label phase I trial of IV Favipiravir and IV Favipiravir plus Ribavirin vs optimised standard of care in CCHF. The phase Ib will be carried out to test the safety and tolerability of IV Favipiravir in hospitalised patients. Following review of safety, tolerability and PK data from evaluated phase I doses, an IV Favipiravir doses will be selected to progress to phase II. virological efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult in-patients (≥18 years) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test.
2. Ability to provide informed consent signed by study patient or legally acceptable representative
3. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in section 5.4 below) from the first administration of trial treatment, throughout trial treatment and for the duration outlined in trial protocol as well as addition 14 days for women and 7 days for men after the last dose of trial treatment.
4. Severity Grading System (SGS) for CCHF - mild/moderate.
5. Less than or equal to 7 days from onset of CCHF symptoms

Exclusion Criteria:

1. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \<30 mL/min/1.73 m2)
2. Pregnant or breast feeding
3. Anticipated transfer to another hospital which is not a study site within 72 hours
4. Known Allergy to any study medication
5. Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.
6. Positive COVID-19 PCR
7. Previous intolerance of Favipiravir or Ribavirin
8. Haemoglobinopathies
9. Unstable cardiac diseases within 6 months
10. Any participants deemed not suitable, based on investigators opinion.
11. Patients taking the drugs listed in section 8.11 within 30 days or 5 times the half-life (whichever is longer) of enrolment
Utility of Rapid Whole Genome Sequencing in the NICU: A Pilot Study

This is a pilot study involving a prospective group of 15 evaluable patients who will undergo rapid whole genome sequencing in addition to standard of care testing. Subjects will be drawn from children admitted to the NICU at OSF Health Care Children's Hospital of Illinois who meet inclusion criteria. The aims of this study are to evaluate the turn-around time and cost of performing rapid whole genome sequencing (rWGS) compared to standard of care in the diagnosis of genetic disorders among critically ill infants in a regional children's hospital and to describe management outcomes of utilizing rWGS in acutely ill patients less than four months of age.


Eligibility Criteria:
Inclusion Criteria:

Patients in the NICU less than 4 months of age with complex medical presentation of unknown etiology, who have 2 or more of the following are eligible:

* critically ill\* and/or organ dysfunction
* one or more major congenital anomalies
* dysmorphic features and/or abnormal growth parameters
* neurologic impairment (seizure, hypotonia, encephalopathy)
* cardiomyopathy
* features suggestive of a metabolic disorder (eg unexplained/persistent hypoglycemia or acidosis)

  * critically ill - cardiorespiratory insufficiency requiring ventilatory or cardiac support

Exclusion Criteria:

* previously confirmed specific genetic diagnosis (antenatal or postnatal)
* obvious clinical findings for a specific condition that could be tested by targeted gene analysis
* preterm less than 24 weeks post-menstrual age
* ward of the state
* parent/legal guardian refusal to give consent for participation in the study
* patient does not meet eligibility criteria
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.


Eligibility Criteria:
Inclusion Criteria:

* patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria:

* refusal to consent
* previous contrast exposure within 72 hours
Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM

To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCoVLM video laryngeal mask airway, so as to provide reference for its clinical application.

1. At present, there are few studies on intubation through SaCoVLM video laryngeal mask airway. It is proposed that endotracheal intubation through SaCoVLM video laryngeal mask airway is to verify its feasibility.
2. The purpose is to explore the best type of endotracheal tube by observing the success rate of intubation through SaCoVLM video laryngeal mask airway and the incidence of postoperative adverse reactions.
3. By observing the hemodynamic changes of the polyvinyl chloride tubes and the wire-reinforced tube during intubation through SaCoVLM video laryngeal mask airway , the effects of the two tracheal tubes on the hemodynamics of patients were compared.
4. By observing the optimized operation which can improve the success rate of tracheal intubation in the experiment, it can be better applied in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to accept elective laparoscopic surgery under general anaesthesia.
2. Aged 18-70 years.
3. Body mass index (BMI) 18.5-27.9 kg/m2.
4. ASA class I-III.

Exclusion Criteria:

1. Neurological or psychiatric diseases (such as schizophrenia and depression), or unconscious.
2. Severe cardiopulmonary dysfunction.
3. Vocal cord injury, pharyngeal disease or history of neck surgery.
4. Risk of reflux aspiration and indwelling nasogastric tube before and after surgery.
5. Mouth opening less than 2 cm, limitation of cervical extension, modified Mallampati score IV.
6. SaCoVLM glottic exposure grade 3 or 4.
7. Participated in other clinical studies during the last 3 months.
8. Refused to give informed consent for the clinical study.
Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder

This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.


Eligibility Criteria:
Inclusion:

* Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive.
* Currently under the care of a physician for psychiatric illness.
* Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data.

Exclusion:

* Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.
Pediatric Expanded Access Program-Oral Solution (0831-908)

Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Not tolerating current ART regime laboratory status is stable
* Able to take oral liquid medications but have difficulty swallowing capsules
* Weigh at least 10 kg (22 lbs)

Exclusion Criteria:

* Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to taking study drug
* Have taken another investigational drug 30 days before starting this study
* Have a history of drug or alcohol abuse
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.


Eligibility Criteria:
Inclusion Criteria:

Cytoreductive surgery with HIPEC patients:

* Able to give informed consent
* Age ≥ 18 years
* Diagnosed with peritoneal metastases from colorectal cancer
* Planned to undergo cytoreductive surgery with HIPEC

Minimally invasive rectal cancer patients:

* Able to give informed consent
* Age ≥ 18 years
* Diagnosed with rectal cancer
* Planned to undergo minimal invasive rectal cancer resection with one of: total mesorectal excision, partial mesorectal excision or abdominoperineal excision

Exclusion Criteria (both groups):

* Thromboembolic event within 90 days before surgery
* Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.