cyrilzakka/clinical-trials huggingface dataset:
Incentivizing Behavior Change Skills to Promote Weight Loss

The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.

In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.

Eligibility Criteria:
Inclusion Criteria:

* desire to lose weight;
* agree to attend visits per protocol;
* access to telephone and transportation;
* English speaking;
* able to complete study measures;
* smart phone with data and texting plan;
* body mass index 30 kg/m2 or greater

Exclusion Criteria:

* pregnancy, breastfeeding, or lack of birth control if premenopausal
* dementia, excessive alcohol use, or psychiatric illness
* weight loss \>4.5 kg in month prior to screening
* weight \> 380 lb (due to limit of cellular scale)
* enrollment in other weight loss program
* residing in nursing home or receiving home health care
* unable to attend weight loss group at scheduled times
* impaired hearing
* medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
* unstable heart disease in 3 months prior to screening
* furosemide 40 mg or higher (or equivalent)
* chronic kidney disease
* 2 or more errors on cognitive screener
* blood pressure ≥160/100 mmHg
NCCLS Interpretive Criteria for Salmonella

To determine the clinical significance of gene mutations encoding antibiotic resistance, but not expressed as clinical resistance, in Salmonella bacteria

Observational study. Physicians in foreign countries caring for patients with Salmonella meningitis or bloodstream infections will collect data on the patients they care for and send this data and an isolate of the organism causing the infection to the University of Pittsburgh.

Eligibility Criteria:
Inclusion Criteria:

* salmonella positive isolate
Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

Elevated homocysteine levels are associated with depression and cognitive impairment. When depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of the present study is to investigate, whether repeated ECT treatment leads to changes in homocysteine levels and if these changes are associated with the occurrence of cognitive impairment after ECS.

10 patients suffering from therapy-resistant depression shall be enrolled. Patients are treated with repeated ECT (three times the week). Before, directly after and one day after ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive symptomatology is checked with different rating scales.

BACKGROUND:

Elevated homocysteine levels have been found in depressive disorders. The modulating effects of homocysteine on glutamatergic neurotransmission have been discussed to be an underlying cause of depression and can also lead to cognitive impairment and may facilitate seizures. Electroconvulsive therapy is the most effective treatment for depression, but often leads to cognitive impairments.

HYPOTHESIS:

Homocysteine levels normalize during rECT. This normalization is associated with the clinical improvement of depression. Short term changes in homocysteine levels (i.e. increase directly after ECT) may explain the cognitive impairments of the patients.

METHOD:

10 patients with therapy-resistant depressive disorder are to be enrolled into the trial. Patients are treated with rECT, two to three times a week. Blood withdrawal and psychometric analysis will be performed before, directly after and one day after ECT treatment 1,4,7,10,(13). Necessity of further treatment will be checked after the first 6 ECTs.

Eligibility Criteria:
Key Inclusion Criteria:

* Men and women aged 18 years or above
* Diagnosis of major depressive disorder (according to DSM IV)
* Secured therapy resistance (at least two trials with antidepressive medication of different classes for more then 4 weeks in adequate dosage)
* Written, informed consent

Key Exclusion Criteria:

* Major neurological or other diseases
* Current medication with antiepileptic drugs
* History of major head trauma
* Any medical condition not allowing anesthesia
Standard Treatments of Very-early Stage Hepatocellular Carcinoma

The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma
2. Tumor diameter\<2cm
3. Child-Pugh class A liver function
4. Without major organ dysfunction
5. male or female patients \> 18 years and \<=70 years of age
6. Voluntary participation in this clinical trial

Exclusion Criteria:

1. Other anticancer treatment before therapy
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women
Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

The primary objective of this study is to determine the detection rate of two- or three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13 6/7 weeks gestation.

Hypothesis: Detection rate of the number of vessels during first trimester will be as accurate as the detection of vessels during the second trimester.


Eligibility Criteria:
Inclusion Criteria:

* Singleton or multiple-gestation pregnancies in patients presenting for NT screening between 11 and 13 6/7 weeks gestation and CRL between 45-84mm as determined at the time of the ultrasound
* Age 18 and older

Exclusion Criteria:

* Patients who are incapable of informed consent or minors
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance.

Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Accept the Informed Consent.
2. Subjects of research males aged 40 to 45 years;
3. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;
4. Be considered healthy, from the analysis of the clinical history and medical examination;
5. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.

Exclusion Criteria:

1. Have donated or lost 450 mL or more of blood in the three months preceding the study;
2. Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;
3. Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began;
4. Have been hospitalized for any reason, up to 8 weeks before the study;
5. Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;
6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
7. Amendments pressure of any etiology requiring pharmacological treatment;
8. Present history of myocardial infarction, angina and / or heart failure.
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

The objective is to assess efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery)
* Patients with anterior chamber cell score ≥2 on the next day of surgery
* Male and female patients aged ≥20 years (on the day of obtaining informed consent)
* Patients giving written informed consent prior to initiation of the study

Exclusion Criteria:

* Patients who did not meet all of the above inclusion criteria
* Patients receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product
* Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product)
* Patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme
* Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery)
* Patients with endogenous uveitis
* Patients planning to undergo surgery of the contralateral eye during the study period
* Patients with new intraocular bleeding after surgery
* Patients receiving gas or silicon oil in the vitreous body
* Patients with glaucoma or ocular hypertension (IOP on the next day of surgery ≥25 mmHg)
* Patients with superficial punctuate keratopathy or corneal ulcer
* Patients with any viral, bacterial or fungal keratoconjunctival disease
* Patients with allergy to any corticosteroid
* Patients requiring use of contact lens during the study period
* Women who were or might be pregnant, or lactating women
* Patients participating in another clinical study within 3 months before initiation of the present study
* Patients undergoing surgery under systemic anesthesia
Safety and Efficacy of Softgel KOVIR (TD0068) in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)

The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches, loss of taste or smell.

The capsule KOVIR is a product based on the traditional medicine which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.

The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported symptoms have included, but are not limited to fever or chills, cough, shortness of breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal pain, anorexia, and vomiting.

The capsule KOVIR is a product based on the traditional prescription which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.

The study timeline is expected from July 2021 to December 2022, including enrolment period, 14 days of treatment, data entry and analysis.

The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and placebo combined with background treatment in COVID-19 patients.

All participants will be treated and followed up in 14-day period. In case the participant meets the discharge criteria before 14 days, discontinuing the study drug will be done at the discretion of the investigators.

Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age from 18 to 65 years old, Vietnamese nationality
* Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test. - Quantitative test results for viral load \> 4log and or CT value \< 30 respiratory fluid samples with the time of sampling within 24 hours from the time of initiation of study treatment.
* Voluntary participation in the study by signing an informed consent
* Ability to adhere to treatment according to the investigator's assessment

Exclusion Criteria:

* Symptoms of severe influenza or severe acute respiratory infection (as defined by WHO).
* Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:

  * Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
  * Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
  * Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
* Allergy/intolerance to any component of the study drug.
* Inability to administer medicine.
* Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* Other active cancer
* Cardiac abnormalities
Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft

The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.

Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, over 18 years old.
* In need of removal of a maxillary or mandibular molar first or second molar.
* The molars to be extracted had to be bordered by at least one tooth.
* The molars had to have a presence of \> 2 mm of keratinized gingiva and three intact bony walls.
* A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
* Only one extraction per patient was accepted.

Exclusion Criteria:

* Acute periodontal or periapical infection.
* Pregnancy or lactancy.
* Smokers of more than 10 cigarettes per day.
* Previous adverse reactions to the biomaterials used in the study.
* Metabolic diseases affecting the mechanism of bone remodelling.
* Medications or treatments taken in the last twelve months and known to affect bone "turnover".
* Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
* Patients with absence of periodontal health maintenance or postoperative recommendations compliance.
Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX

The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Males patients aged 18 years or over on entry into the trial
* Patients who have non-metastatic cancer that is confirmed by histology or cytology. This primary treatment should have been completed in the last 8 weeks
* The stage should be T1b/T1c/T2/T3/T4 any N category
* Paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
* Be able and prepared to comply with trial procedures and restrictions
* Have a life expectancy greater than 2 years

Exclusion Criteria:

* Any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
* Patients with any concurrent malignancy (except for basal cell or TO-2 NO MO squamous cell carcinoma of the skin). History of previous malignancy or treatment for any cancer in the past 5 years
* Previous history of mastectomy including a Webster operation or radiation therapy to the chest area
* Any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
* Any evidence of pre-existing gynaecomastia or breast pain
* Patients with history or presence of testicular abnormalities (as CASODEX can potentially aggravate testicular tumours)
* Patients with any concurrent disease or condition that in the opinion of the treating physician, would constitute a hazard for participation in this study or may interfere with the patient's ability to comply with the scheduled visits and assessments. This includes patients whose physical build would prevent reasonable assessment of gynaecomastia
* Liver disease (bilirubin greater than 2.0mg/dL; AST/ALT greater than 2 times the upper limit or normal)
* Patients taking the following drugs; terfenadine, cisapride, astemizole, cyclosporin, and warfarin are excluded from the trial due to the possibility of drug interaction
* Patients with a known history of alcohol abuse
* Concurrent treatment with any druges known to have high potential for causing gynaecomastia or breast pain, eg.Spironolactone, steroid therapy, cimetidine and neuroleptic agents.
* Treatment with a new chemical entity within the previous 4 months or current participation in another clinical trial involving an investigational product
* Patients considered by the investigator to be at risk of transmitting any infection through the body or other body fluids, including acquired immue dificiency syndrome (AIDS) other sexually transmitted diseases or hepatitis
Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes

To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.

This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-40 years.
* Body weight of ≤ 80kg.

Exclusion Criteria:

* History Chronic kidney disease.
* History of dairy allergy or intolerance.
* History of gastric reduction/bypass surgery.
The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section

This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in cesarean section. Half of participants received general anesthesia, while the other half received spinal anesthesia Electrocardiography (ECG) recordings were performed at preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively. Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records at predetermined time intervals of spinal or general anesthesia.

The anesthetic drugs used according general or regional anesthesia techniques can display proarrhythmic and antiarrhythmic effects by inducing cardiac electrical signals with different pathways.In addition, comorbid disease, hormonal changes, surgery procedures, and drug therapy can all cause arrhythmia in the intraoperative period. Likewise, pregnancy causes many changes hormonal and physiological in women. Hemodynamic and hormonal changes during pregnancy can cause effects proarrhythmogenic that cause premature atrial and ventricular beats to develop.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-II
2. ages 20-40 years
3. parturient patients

Exclusion Criteria:

1. spinal cord and peripheral nervous system diseases;
2. hypovolemic and hemorrhagic shock;
3. increased intracranial pressure;
4. severe anemia;
5. systemic infection;
6. scoliosis;
7. congenital spinal anomalies;
8. vertebral colon metastatic lesions;
9. anticoagulant drug use;
10. diabetes mellitus;
11. hypo/hyperthyroidism;
12. atrial and/or ventricular hypertrophy on ECG;
13. cardiomyopathy;
14. valvular disease;
15. cardiac failure or chronic disease;
16. cardiomegaly
17. used medication causing QT interval prolongation.