cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.

Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to each dosing period.

Subjects were randomized into one of two active treatment groups, received supervised dosing of their treatment with approximately eight ounces of water, and were required to maintain fluid restriction for one hour after treatment. Following the one-hour post-dose fluid restriction, subjects could drink water, but consumer no other food or fluids for four hours post-dose.

Following a seven-day washout period, the comparison treatment was administered according to the same procedure as above.

Eligibility Criteria:
Inclusion Criteria:

* healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* approximately 18 to 30 kg/m2 BMI
* total body weight at least 55 kg (121 lbs)
* able to understand and sign the written Informed Consent Form
* willing to follow the protocol requirements and comply with protocol restrictions

Exclusion Criteria:

* pregnant or lactating women
* women of childbearing potential not using acceptable form of contraception 3 months prior to the first dose until completion of follow-up procedures
* history of allergy, sensitivity, and/or idiosyncratic reaction to Benadryl, diphenhydramine hydrochloride, or diphenhydramine citrate
* evidence of clinical, dietary or psychiatric deviation from normal that could increase the risk to the subject or research staff or interfere with the interpretation of study results
* use of licit or illicit drugs
* participated in any other trials within a specified number of days prior to the first dose of the trial treatment
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section

The purpose of this multicenter study is to evaluate the effectiveness and safety of dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean section


Eligibility Criteria:
Inclusion Criteria:

1. Parturients undergoing elective caesarean delivery under spinal anaesthesia
2. American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies
3. Parturients with the ability to understand verbal and written mandarin
4. Parturients who want to use PCA intravenous analgesia and can use the pump correctly
5. Parturients whose written informed consent have been obtained

Exclusion Criteria:

1. A history of allergy to dexmedetomidine or other study drugs
2. A long use history of opioid analgesic, NSAIDs, tranquilliser use
3. Psychiatric disorders
4. A history of neuromuscular and endocrine disease or allergic disease
5. A history of lower abdominal surgery
6. Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities
7. spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia
8. A second operation is required during the study.
9. Participating other study during the latest three months
10. Body mass index more than 30 kg/m2
11. Difficult airway ( Mallampati score more than 3 and anatomic deformity )
12. Not suitable for participation estimated by investigation
Ceftriaxone and Jaundice in Neonates

Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for sepsis and investigators will observe the effect on jaundice.


Eligibility Criteria:
Inclusion Criteria:

* Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life.

Exclusion Criteria:

* Infants with asphyxia (Apgar score \<3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home.
Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment

This study aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients have never been diagnosed with hypertension.
* Patients have been diagnosed with primary hypertension, but not take any treatment

Exclusion Criteria:

* Cases with non-primary hypertension or suffering from cardiovascular complications such as myocardial infarction, cerebral stroke, vascular disease, severe heart failure (EF\<1) in the time of measurement.
Remote Exercise SWEDEHEART Study

The overall aim of the study is to evaluate if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase participation in exCR sessions post myocardial infarction (MI).

Due to the covid-19 pandemic, this study will be performed in two steps:

1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT).

1. In the feasibility study, patients will be offered remote exCR at all participating sites until the peak of the pandemic has been achieved and care goes back to normal. The feasibility study will include patients until Aug 2022.
2. CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote exCR, usual care centre-based exCR, or a combination of both modes, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months. Long-term follow-up will be performed 1 year and 3 years after the index cardiac event.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of type 1 myocardial infarction (AMI)
* Age 18-79 years at discharge from hospital

Exclusion Criteria:

* Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis
* Severe valve or structural heart disease
* Severe heart failure (NYHA III - IV)
* Serious arrythmias
* Inability to understand Swedish
* No internet access at home (only applicable for patients in the intervention group who wants to perform remote exCR)
* Pathological exercise test indicating high risk for adverse events during exCR
* More than 6 months between discharge form hospital and screening
* Any other condition that may interfere with the possibility for the patient to comply with the study protocol
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.

The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are premenopausal.
* Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
* Patients who are 20 years old or older.
* Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.

Exclusion Criteria:

* Patients who are 65 years old or older.
* Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
* Presence of malignant tumor or diagnosed with cancer.
* Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
* Patients who are unwilling to comply with study procedures.
* Patients who are known to have hypersensitivity to hyaluronic acid implants.
A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients with Pre-cachexia or Cachexia

An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.

Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the study and sign the informed consent form.
2. Men or women between the ages of 18 and 80 years at the time of written informed consent.
3. Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI \< 21 kg/m2 within 6 months before the first study dose.
4. Persistent concomitant appetite/eating problems related to cancer.
5. It has adequate organ function.
6. The ECOG PS score was 0-2.
7. The investigator judged the expected survival time to be ≥ 3 months.

Exclusion Criteria:

1. With active brain metastases.
2. With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
3. Baseline BMI \> 28 kg/m2.
4. With infectious diseases.
5. With clinically significant cardiovascular disease.
6. With uncontrolled metabolic diseases.
7. With known clinically significant allergic reactions to antibodies and excipients.
8. With history of drug or alcohol abuse.
9. Pregnant or lactating female subjects or women planning to become pregnant during the study.
10. With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
11. Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.
Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment

Iron deficiency is defined by insufficient tissue iron stores and anemia is the ultimate stage of iron deficiency. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications

Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology.

In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.

Iron deficiency (MD) is defined by insufficient tissue iron stores. Since iron is essential for the synthesis of hemoglobin, when the iron deficiency no longer makes it possible to maintain a sufficient level of erythropoiesis, anemia appears: it is the ultimate stage of iron deficiency.

Anemia is the most common haematological pathology encountered in geriatric practice. Its prevalence, in population generally ambulatory, is between 10 and 15% after the age of 65 and is greater than 20% beyond the age of 85.

Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications heart disease, cognitive decline, frailty, hospitalizations, and impairment of quality of life. About a third of anemias elderly person is attributable to a deficiency in vitamin B9 or B12 or an iron deficiency.

Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic such as heart failure, kidney failure chronic or cancer, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology.

In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.

This diagnosis is all the more important because, depending on the chronic pathology, data from the literature have shown that correcting the iron deficiency brings benefits to the patient by reducing the risk of recurrence of anemia, the prescription of erythropoietin and the use of transfusion for patients in oncology, gastroenterology and nephrology

Eligibility Criteria:
Inclusion Criteria:

* Any patient hospitalized in a geriatric unit (short geriatric stay, SSR) or seen on an outpatient basis (hospitalization day, consultation)
* Affiliated patient or beneficiary of a social healthcare system
* Patient having given written consent

Exclusion Criteria:

* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration
A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B

The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

Essential Hypertension

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients with Essential Hypertension
* Other inclusions applied

Exclusion Criteria:

* Patient with Secondary Hypertension
* Other exclusions applied
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Eligibility Criteria:
Inclusion Criteria:

* locally advanced or recurrent rectal cancer
* suitable for radical surgery but at high risk of positive resection margins,
* no evidence of metastasis,
* age greater than 18 years,
* histologically confirmed adenocarcinoma,
* ECOG performance status \<2.
* Informed consent

Exclusion Criteria:

* unresectable pelvic disease
* distant metastasis
* significant co-morbidities
Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence

: Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique for management of Cases With Labial Plate Dehiscence

In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Eligibility Criteria:
Inclusion Criteria:

* Non-restorable teeth in the esthetic zone with a defect of labial bone.
* Teeth with no acute inflammation.
* Patients are free from any systemic condition that may affect the healing.
* Availability of bone apical and palatal to the socket to provide primary stability
* Good oral health.
* Willingness to sign the informed consent form.

Exclusion Criteria:

Heavy smoker (\> 10 cigarettes/day)

* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* Acute inflammation in the site of implantation and adjacent tissue.
* A history of radiotherapy in the head or neck region.
* Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation
A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

The purpose of this study is to evaluate the proportion of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and Refresh® Classic.

This is a 1-visit study (Screening, Enrollment, Assessments).

Eligibility Criteria:
Key Inclusion Criteria:

* Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
* Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
* Capable of giving signed informed consent.

Key Exclusion Criteria:

* Current evidence of other clinically significant ophthalmic disease other than dry eye;
* History of ocular surgery within 1 year of the Study Visit;
* Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
* Positive pregnancy test or currently breastfeeding.
BEYOND Weight Loss Maintenance Study

A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.

Introduction: Long-term maintenance of non-surgical weight loss remains the most significant problem in obesity treatment. This study will compare the effectiveness of two different weight loss maintenance strategies used as part of the Counterweight Plus weight management programme. This study will also evaluate the behavioural impact of the Counterweight Plus interventions and include process evaluations and cost analysis.

Methods: 80 patients and 10 practitioners will be recruited into the study. Main inclusion criteria for patients are:

Completed Counterweight Plus, which includes 12-20 weeks total diet replacement (TDR), 8 weeks food reintroduction (FR) and achieved \>10kg weight loss. All participants will be followed up for 18 months in total.

Results: The primary outcome of this study is the difference in weight change between the two groups at 6 months. Frequency of use of behavioural strategy will be quantified for both practitioners and patients during voice recorded consultations. The relationship between weight change and the use of behavioural strategy will be assessed.

Hypothesis: This study will establish if the novel intermittent use of formula diet strategy is more effective at preventing weight regain in comparison to usual care. It will also provide evidence of the frequency of use of behavioural strategies within routine Counterweight Plus delivery, as well as establishing the cost of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved \>10kg weight loss

Exclusion Criteria:

* People currently participating in another clinical research trial (not including BEYOND Weight Loss study)
Assessment of Knowledge, Attitude and Practice of Primary Care Doctors Towards Common Dermatologic Conditions in Sudan

The goal of this observational study is to assess the knowledge, attitude, and practice of primary care physicians regarding the common dermatologic conditions in Sudan. The main question it aims to answer is:

What is the level of knowledge of primary healthcare doctors regarding common dermatological conditions in Sudan? what is the attitude and practice of primary healthcare doctors regarding common dermatological conditions in Sudan?

Dermatological conditions represent a major global health burden and significant portion of primary healthcare visits. Primary healthcare physicians are the backbone of medical care and they are usually the first responders to deal with skin diseases. Therefore, it is essential for primary care doctors to possess the sufficient knowledge and the best practice to achieve the best possible outcomes. Assessing the knowledge, attitude and practice of doctors will help identify the areas of weakness and address the gaps.

Our online based cross-sectional study involved primary healthcare doctors across the 18 states of Sudan. The study utilized multistage sampling to select the participants to fill the online questionnaire that is intended to assess the knowledge of the participants using a photo quiz, the attitude using likert's scale based assessment and the practice.

the study explored the factors which may affect the knowledge attitude and practice of doctors like the age, sex, years of clinical experience, and number of cases seen per day.

Eligibility Criteria:
Inclusion Criteria:

* Primary care doctors above 23 years of age
* Work in primary healthcare settings in Sudan during the period of the study.

Exclusion Criteria:

* Doctors less than 23 years of age
* Not located in Sudan
* Didn't work in primary care facilities
FreezIng bReaST Cancer in Brazil: a Before-after Study

Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).

Outline

1. Core biopsy
2. Mammogram
3. Magnetic resonance imaging
4. Ultrasound
5. Tumor Cryoablation
6. Mammogram (post-cryoablation)
7. Magnetic resonance imaging (post-cryoablation)
8. Ultrasound (post-cryoablation)
9. Surgery
10. Evaluation of outcomes

Eligibility Criteria:
Inclusion Criteria:

* Unifocal primary invasive breast carcinoma
* Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary)
* Maximum tumor size ≤2.5 cm in its greatest diameter
* Ultrasound visible lesion

Exclusion Criteria:

* Multifocal or multicentric invasive breast carcinoma
* Ductal carcinoma in-situ
* Breast cancer with skin involvement
* Clinically positive axilla (N1, N2 or N3)
* Distance from lesion and skin less than 5 mm
* Prior neoadjuvant systemic therapy for breast cancer
* Distant metastasis