cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions

The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.

A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.

Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.

Eligibility Criteria:
Inclusion Criteria:

* Subject candidates must fulfill all of the following inclusion criteria t be eligible for participation in the study, unless otherwise specified:

  1. Healthy adult male or female volunteers, 18 to 55 years of age
  2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
  3. Medically healthy subjects with clinically normal laboratory profiles and ECGs
  4. Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
* Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
* IUD in place for at least 3 months
* Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
* Surgical sterilization of the partner (vasectomy for 6 months minimum)
* Hormonal contraceptives for at least 3 months prior to the first dose of the study
* Other birth control methods may be deemed acceptable e) Post menopausal women with amenorrhea for at least 2 years will be eligible f) Voluntarily consent to participate in the study

Exclusion Criteria:

* Subject candidates must not be enrolled in the study if they meet any of the following criteria:

  1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  2. In addition, history or presence of:
* alcohol or drug abuse within the past year
* hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin c) Female subjects who are pregnant or lactating d) Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study e) Subjects who through completion of the study, would have donated in excess of:
* 500 mL of blood in 14 days
* 1500 mL of blood in 180 days
* 2500 mL of blood in 1 year f) Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection VS MBT Placement Guide Bonding Strategies

The study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients.

The study concisits of two groups, the intervention group entails performing bonding of orthodontic brackets following smile arc protection bonding strategy while the control group entails performing bonding using the MBT placement guide and comparing the final smile outcomes after reaching steel archwires for both groups using customized questionnaires for orthodontists and laypersons.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* no/mild/moderate crowding or spacing
* non-extraction treatment decision with non-extraction profile
* adults age 16-30 years
* full permanent dentition including fully erupted 7s not necessarily 8s
* good oral hygiene.

Exclusion Criteria:

* severe crowding
* cleft lip and palate/syndromic patients
* bad oral hygiene
* unerupted or partially erupted 7s
* extracted or missing teeth
A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)

The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
* Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
* Able to swallow multiple capsules
* In good health

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
* History or presence of clinically significant sick sinus syndrome
* History of cancer (malignancy) within the past 5 years
* Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
Prolonging Remission in Depressed Elderly (PRIDE)

This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.

While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT.

This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy "usual care" comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM).

At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores \>21 at two consecutive time points, suicidality, or psychiatric hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV
* ECT is clinically indicated

Exclusion Criteria:

* Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation
* Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria
4SCAR-CD44v6 T Cell Therapy Targeting Cancer

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers. The study also aims to learn more about the function of the CD44v6 CAR-T cells and their persistency in the patients.

CD44 variant domain 6 (CD44v6) which belongs to CD44 family has been implicated in tumorigenesis, tumor cell invasion and metastasis. The expression of CD44v6 was reported for the majority of squamous cell carcinomas, a proportion of adenocarcinomas of differing origin, a proportion of melanoma and lymphoma. This expression pattern has made CD44v6 an attractive target for the therapy of various types of CD44v6 positive cancers.

The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize specific molecules - CD44v6 expressed on the surface of the cancer cells. The engineered T cells will be applied to patients through intravenous delivery.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CD44v6 CAR-T cell therapy in multiple cancers including - but not limited to - stomach cancer, breast cancer, prostate cancer, multiple myeloma and lymphoma which are CD44v6 positive. Another goal of the study is to learn more about the function of the 4SCAR-CD44v6 T cells and their persistency in the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 6 months.
2. Confirmed expression of CD44v6 in tumor specimens by immuno-histochemical staining or flow cytometry.
3. Karnofsky performance status (KPS) score is higher than 70 and life expectancy \> 3 months.
4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
5. Hgb≥80g/L.
6. No cell separation contraindications.
7. Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. Pregnant or nursing women may not participate.
5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
6. Receive treatment related to CD44v6 targeted therapy.
7. Patients, in the opinion of investigators, may not be able to comply with the study.
Telerehabilitation Following Meniscectomy

Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. Since telerehabilitation was found to be equally effective as conventional therapy, it was being practiced even before the COVID times, however it was truly valuable during the lockdown. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the proposed study is to evaluate telerehabilitation vs in-person rehabilitation following Meniscectomy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for meniscectomy
* Age 18-75
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant patient
* Age \>75 years, or \< 18
* Previous knee surgery
* Unable to speak English or perform informed consent
Prevalence of Low Back and Pelvic Pain in Pregnant Women

The purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women. The results should allow for the identification of factors associated with a greater risk of having it during pregnancy. Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.

Validated methods were used to gather data on the prevalence of LBP, LP and PGP, anthropometric and socio-demographic characteristics, history of LBP, obstetrical history, physical activity before and during pregnancy, mattress and sleep characteristics, disability, anxiety, and depression. Separate multiple logistic regression models were developed to identify the variables associated with LBP, LP and PGP.

Eligibility Criteria:
Inclusion Criteria:

* A pregnancy of 28 weeks or more
* Able to understand, read and write Spanish
* Seen at participating health centers or hospitals in the study
* Signs informed consent form

Exclusion Criteria:

* Refusal to participate in the study
* Being under 18 years of age or legally mentally incapacitated
* Having a diagnosis of illnesses that can cause back pain
Use of Red Cell Distribution Width for Prediction of New-onset Atrial Fibrillation in Critically Ill Sepsis Patients

Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population..

This study was done retrospectively on sepsis patients admitted to intensive care units. data will be retrieved from patient medical records. The primay end point will be occurrence of new-onset AF during ICU stay. The secondary outcomes will be 28-day mortality.

The presence of anisocytosis or RDW variations has been classicaly used as a test for iron deficiency anemia. Increasing evidence points to its potential as a predictor for various conditions such as heart failure , malignancy, ischemic heart disease and sepsis.

Study investigators will examine the relationship between RDW levels and incidence of atrial fibrillation in critically ill sepsis patients as well as 28-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* For all patients According to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) , adult patients with suspected infection are identified, having quickSOFA (qSOFA) score meeting ≥2 of the following criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mmHg or less
* Sepsis patients with newly developed Atrial fibrillation during ICU stay.

Exclusion Criteria:

All patients with concomitant valvular disease, cardiomyopathy, cardiac dysrhythmias, previous cardiac surgery, secondary hypertension, hyperthyroidism, severe head injury, stroke, coma, acute coronary artery disease or underlying cardiac dysfunction\[cardiac index (CI) \<2.2 l/min/m 2 \], severe liver disease (Child-Pugh grade C), chronic renal failure were excluded from the study. In addition, pregnant patients were excluded.
Repurposing Chlorpromazine in the Treatment of Glioblastoma

This study evaluates the addition of chlorpromazine to the first-line therapeutic protocol, i.e. maximal well-tolerated surgical resection followed by radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide, in newly diagnosed glioblastoma multiforme patients carrying a hypo-methylated O6-methylguanine-DNA-methyltransferase (MGMT) gene

Chlorpromazine (CPZ, Largactil, Thorazine) is a potent antagonist of the dopamine receptor D2 (DRD2) and has been effectively and safely employed for over half a century in the treatment of psychiatric disorders. CPZ displays a series of remarkable bio-molecular effects in cancer cells, as inhibition of cell growth, nuclear aberrations, inhibition of the phosphoinositide 3-kinase/mammilian target of rapamycin (PI3K/mTOR) axis, induction of cytotoxic autophagy, inhibition of glutamate and DRD2 receptors.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed histologically-confirmed supra-tentorial GBM (World Health Organization grade IV) patients. Whenever feasible, patients will undergo maximal surgical resection or debulking, although patients with inoperable glioblastomas are also eligible.
2. Progression-free patients after having undergone maximal safe debulking surgery when feasible or biopsy, and
3. Patients undergone completed standard concomitant chemo-radiotherapy with temozolomide
4. Patients with provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
5. Patients (both males and females) should employ adequate contraceptive measures which should be maintained during the whole duration of the trial
6. Additional eligibility criteria include: age between 18 and 70; Karnofsky Performance Status (KPS) score of 70 or higher; adequate kidney, liver, bone marrow, and cardiac function; total serum bilirubin level and liver- function values; isocitrate dehydrogenase 1/2 (IDH1/2) mutational status; MGMT methylation status assessment.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria apply:

1. Treatment with any of the following:

   * Any other chemotherapy, immunotherapy or anticancer agents within 4 weeks before enrollment in the study.
   * Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment.
   * MGMT methylated
2. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including: uncontrolled hypertension; active bleeding diatheses; active hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV infection. Screening for chronic conditions is not required; inadequate bone marrow reserve or organ function, as demonstrated by laboratory parameters.

4. Judgment by the investigator that the patient should not participate to the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

5. Contraindications to MRI and or magnetic resonance spectroscopy (MRS). 6. Patients not able to sign informed consent.
The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Total Knee Arthroplasty in spinal anaesthesia
* ASA 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of strong opioids
* Unable to complete the Timed Up and Go test preoperatively
Brain Training Tools With Physical Practice on Motor Learning

This study evaluates the influence of motor imagery and action observation in combination with physical practice on motor learning


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects
* men and women between 18 and 65 years of age
* participants with no systemic, neurological, cognitive or psychological disease.

Exclusion Criteria:

* underage participants
* presence of systemic pathology, pain and/or weakness that prevents the protocol
* participants who have undergone an operation in the spine.
Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia

The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male patients age 18 to 60 years at the time of enrollment.
2. Men who have self-perceived thinning hair.
3. Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Key Exclusion Criteria:

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.
In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.

This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.

As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the \&#34;surgical ceiling\&#34;, but because of its high postoperative complication rate and poor prognosis, a standardized surgical quality assessment system covering the whole perioperative period is urgently needed. The concept of the textbook ending was born.it first appeared in a 2013 study by Kolfschoten et al for colorectal cancer, in which textbook outcomes were evaluated in an all or none ,manner against six independent expected outcome measures: There were no deaths in hospital or within 30 days after surgery, radical resection, no re-intervention, no stomy, no serious postoperative complications, and no prolonged hospital stay. That is, when patients meet the above six indicators at the same time, they are defined as achieving a textbook outcome .In our study, the textbook outcome is the primary outcome, and the reverse is the secondary outcome.This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received radical PD surgery and whose pathological findings were clear tumors;
2. Complete clinical data preservation.

Exclusion Criteria:

1. Palliative resection; 2. Tumor metastasis or other primary tumors; 3. Combined with severe organ dysfunction; 4. Postoperative pathology was not clear tumor.

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