cyrilzakka/clinical-trials huggingface dataset:
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Diabetes mellitus
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.


Eligibility Criteria:
Inclusion Criteria:

* NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment
* At least having one measurable metastatic lesion
* All genders，range from 18～70 years old
* ECOG score 0 \~ 1
* Expected survival time ≥ 3 months
* White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L
* Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min
* Inform consent form

Exclusion Criteria:

* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension.
Dynamic Measures of Neurochemistry in Mood Disorders

The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.

The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.

Eligibility Criteria:
Inclusion Criteria:

* AGE RANGE: 18 to 50 years.
* WEIGHT: within 20% of ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical risks of poor access in overweight individuals, and because of physiologic risks in underweight individuals.
* SEX DISTRIBUTION: both men and women (self or partner surgically sterilized, or using double barrier method). To the extent possible, women will have CSF sampling at the same point in their menstrual cycles, ideally during the follicular phase.
* RACE: any
* HEALTH: healthy, ambulatory depressed or healthy adults; must show clear capacity to form consent based on a strong understanding of the potential risks and benefits.

Exclusion Criteria:

* Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities, history of deep venous thrombosis (DVT), thrombophlebitis, coagulopathy.
* Pregnancy.
* Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
* Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
* Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Patients who have taken any unapproved prior or concomitant medications.
* Patients who have donated blood within one month of the study.
* Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
* Recent participation in other studies.
* Patients with histories of migraine will be considered individually, and warned of the risk of headache following spinal tap.
* Patients who smoke regularly, would experience withdrawal while hospitalized for 5 days, or who cannot abstain from tobacco for the entire duration of the study.
* Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Children 4 to 8 years of age
* Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
* Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Exclusion Criteria:

* Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
* History of previous hepatitis B vaccine
* History of vaccination with any hepatitis B vaccine (Cohort C only)
* Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
* Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
* Impairment of immunologic function or recent use of immunomodulatory medications
* A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)
Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis

Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.

Anastomotic leakage is an important and probably the most feared complication in colorectal surgery, due its high rate of morbidity, prolonged hospitalization and mortality.

The incidence of colorectal anastomotic leakage varies between 4 and 20%, and it definition is dissimilar depending on the articles reviewed. However, results from the Dutch Colorectal Surgery Audit, published in 2010 showed a global leakage rate of 11%.

To decrease this surgical complication several strategies and devices have been developed with discouraging results. Based on the scar theory of platelet concentrates, the use of platelet-rich plasma (PRF) and leukocyte and platelet-rich fibrin plasma (L-PRF) has been proposed to stimulate and improve cicatrization in colorectal anastomosis, showing promising results in animal studies.

L-PRF is a second generation platelet concentrate of better quality and simpler confection, that is obtained by a similar technique developed in France by Choukroun et al, in the absence of anticoagulants or gelling agents. Platelet concentrates and specially L- PRF are use in various areas of odontology and medicine, including colorectal surgery.

The main objective of this study was to evaluate the feasibility of using L-PRF in colorectal surgery and to determine its effect on anastomotic leakage after colorectal anastomosis.

This study was approved by the Ethical and Scientific Committee of Health Service of Concepción city (Code: 17-07-40). All participants were explained their rights and were asked for their consent to enroll them in the study. On the other hand, anonymity and confidentiality of the participants was assured during the study, as the patients personal information was not included in the research database, which was administered only by the main investigator and the statistical analyst.

This study was held following the recommendations of Helsinski Declaration and World Medical Association.

Eligibility Criteria:
Inclusion Criteria:

* Patients were submitted to elective colorectal anastomosis with mechanic anastomosis on or under the peritoneal reflection.
* Postoperative evaluation using contrast enema to objectify subclinical dehiscence.

Exclusion Criteria:

* Age under 15 years
* American Association of Anesthesiologists (ASA) grade IV or higher.
* Clinical signs of peritonitis
* Other major surgeries within 30 days of the procedure.
* Deficient nutritional state (defined by plasmatic albumin levels lower tan 2.8 mg/dl) Active treatment with corticoids and the impossibility of having contrast enema post-surgery.
Evaluation of Maxillary Canine Retraction Assisted With Two Different Methods of Low-Intensity Pulsed Ultrasound

The current clinical study will be done for evaluation of maxillary canine retraction assisted with application of two different methods of low-intensity pulsed ultrasound.


Eligibility Criteria:
Inclusion Criteria:

-

All patients should satisfy the following criteria:

1. An age ranges from 15-22 years.
2. Severe crowding or protrusion requiring 1st premolar extractions followed by symmetrical canine retraction.
3. All permanent teeth present, 3rd molars are excluded.
4. Good oral hygiene.
5. No systemic disease/medication that could interfere with orthodontic tooth Movement (OTM).
6. No previous orthodontic treatment.

Exclusion Criteria:

* 1. Patient diagnosed to have an indication for non-extraction approach. 2. Poor oral hygiene or periodontally compromised patient. 5 3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions. 4. Previous orthodontic treatment. 5. Any implanted assistive devices (e.g., pacemakers, cochlear implants, etc.) 6. Pregnant females.
Use of the SNAP II Electroencephalography (EEG) Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor accurately reflects changes in sedation level in outpatients undergoing surgery or procedures with sedation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I, II or III physical status

Exclusion Criteria:

* Use of inhalation general anesthesia
* ASA IV physical status
Determination of Protein Requirement in Elderly Male Subjects >75 Yrs Old

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current dietary reference intake (DRI) requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by national health and nutrition examination survey (NHANES), the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of male elderly subjects \> 75 years using the indicator amino acid oxidation (IAAO) technique.

Hypothesis:

The investigators hypothesize the protein requirement in elderly male subjects will be lower (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy elderly males \>75 years
2. Willingness to participate in the study
3. Males without a chronic disease or acute illness that could affect protein and amino acid (AA) metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
4. Males with hypertension if well controlled by medications

Exclusion Criteria:

1. Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
3. Significant weight loss during the past month.
4. Individual on weight reducing diets.
5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine)
Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

This study examines the effect of Goeckerman therapy (a combination of phototherapy and topical crude coal tar), crude coal tar alone, and phototherapy alone on the immunologic and genetic environment within psoriatic skin lesions.

This is a three-arm, open-label study to examine the effect of Goeckerman therapy. Goeckerman therapy is known for its high efficacy and favorable safety profile in the treatment of psoriasis. It consists of a combination of phototherapy and topical crude coal tar). This study will examine how Goeckerman therapy, crude coal tar alone, and phototherapy alone affect the mmunologic and genetic environment within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to further elucidate the mechanism of action by which Goeckerman treatment improves psoriatic skin lesions.

Eligibility Criteria:
Inclusion criteria

1. Male or female ≥ 18 years of age at enrollment.
2. Documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment.
3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
4. Subject is considered a candidate for phototherapy or systemic therapy
5. Body Surface Area (BSA) ≥ 5%.
6. Physical exam within clinically acceptable limits.

Exclusion criteria

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Subject has predominantly non-plaque form of psoriasis.
3. Subject has drug-induced psoriasis.
4. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
5. Patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders.
6. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
7. Known HIV positive status.
8. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women

To examine the effect of electromagnetic stimulation combined with visceral manipulation on stress urinary incontinence in postmenopausal women

According to the authors' knowledge, no prior studies that included MS with a VMT maneuvers to improve the success rates of stress urinary incontinence (SUI) treatment. Consequently, the purpose of this study was to assess the effect of electromagnetic field stimulation with VMT and PFMT in treatment of postmenopausal women with SUI.

Eligibility Criteria:
Inclusion Criteria:

Fifty postmenopausal women suffering from SUI with grades mild to moderate, were referred from........Hospital after SUI diagnosis confirmation with urodynamics. They were selected from outpatient clinic of department of physical therapy for Women's Health of the faculty of Physical Therapy, Cairo university. The inclusion criteria included sedentary and medically stable postmenopausal women, with age range of 50 to 66 years old.

Exclusion Criteria:

resence of a urinary tract infection (UTI), other types of UI, previous incontinence and pelvic floor surgeries, metallic implant, contraindications for MS, cognitive alterations, collagen or muscle-related diseases, and neurological abnormalities were exclusion criteria.
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy

The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.

Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting about 30 to 40 minutes, MRI exam includes successive sequences providing complementary information but none relatively to brain perfusion. Perfusion MRI without contrast media injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as a prognostic factor. The purpose of the study is therefore to perform ASL sequence within usual care brain MRI.

Eligibility Criteria:
Inclusion Criteria:

* neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
* presenting with perinatal asphyxia defined as combination of:

  * an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities);
  * and at least one of the following criteria:

    * Apgar score ≤ 5 at 10 minutes of life,
    * mask ventilation or intubation at 10 minutes of life,
    * metabolic acidosis defined as pH \< 7 or base deficit ≥ 16 mmol/L or lactates ≥ 11 mmol/L within the first 60 minutes of life on cord or other arterial venous or capillary blood sample.
* patient treated or not with therapeutic hypothermia for 72 hours.
* affiliated patient or beneficiary of a social security scheme.
* informed and signed parental consent.

Exclusion Criteria:

* perinatal arterial ischemic stroke.
* congenital neuro-metabolic disorder.
* severe malformative abnormalities.
* MRI contra-indication.
* Poor understanding of the holders of parental authority
Creatinine Height Index in Elderly

evaluation of the efficacy of two different age adjusted calculations of CHI compared to other nutritional indicators in the elderly medical patients upon hospital admission.

Cross sectional study involving one hundred hospitalized elderly (\>60 years), Anthropometric measurements, Mini- nutritional assessment, Hand Grip strength, CBC, total protein, albumin, total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured within 24 hours of hospital admission calculation of CHI using 2 age adjusted modification was done accuracy of each measurement in detecting malnutrition was evaluated

Eligibility Criteria:
Inclusion Criteria:

* medical elderly patients (\>60 years)
* within 24 hours of hospital admission

Exclusion Criteria:

* sepsis
* fever
* malignancy
* liver cirrhosis
* renal impairment
* critically ill patients
* those with any hemodynamic instability were excluded from the study
* patients receiving diuretics
* patients can't stand to obtain their weight and height
* those can't collect 24 hour urine
* the patients refused to participate in the study
Safety Improvement and Checklist Application

The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").


Eligibility Criteria:
Inclusion Criteria:

* elective surgery in general or regional anesthesia lasting \> 15 min

Exclusion Criteria:

* urgent surgery
Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake

The purpose of this study is to evaluate the AFIX-OB model to determine its impact on the change in flu and pertussis (Tdap) uptake, provider knowledge, attitudes and beliefs, and patient knowledge, attitudes and beliefs regarding maternal vaccination. The structure of the model and quality improvement interventions are guided by theory including the elaboration likelihood model and P3 model. These quality improvement measures will be implemented in OB clinics within the Yale New Haven Health System.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-50 years of age
* Currently pregnant and gestational age \<26 weeks

Exclusion Criteria:

* Already enrolled in the study