cyrilzakka/clinical-trials huggingface dataset:
Paracervical Block in First Trimester Surgical Abortions

The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.

This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.

The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.


Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18 years
* English-speaking
* ability and willingness to sign the informed consent
* ability and willingness to comply with the terms of the study
* voluntary request for pregnancy termination
* ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle

Exclusion Criteria:

* women who require or request sedation
* untreated acute cervicitis or pelvic inflammatory disease
* contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
* allergic reaction or sensitivity to lorazepam or NSAIDs
* chronic NSAID use
* history of gastritis or gastric ulcer
* acute renal failure or chronic renal disease
* chronic liver disease
* history of bleeding diathesis
* chronic narcotic use
* current or past history of illegal drug use (excluding marijuana)
A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population

To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.

This population-based study enrolled 59 patients (\>45 years old; 70 eyes) with early and intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive standardized ophthalmic examinations included visual acuity, anterior segment analysis by slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early and intermediate-stage AMD patients were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* adults citizens aged above 45 years

Exclusion Criteria:

* lost samples
Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients

1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients.
2. Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).

1. Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review.

   * especially drug-related
2. Find the risk factors of muscle fibers breakdown.

Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to The National Taiwan University Hospital during 2003/1/1\~2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male \> 900 IU/L; female \> 835 IU/L).

Exclusion Criteria:

* Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.
Unilateral Attachment Versus Tooth Implant Supported Bridge

Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.

Materials and methods: Twenty four patients were selected and divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction and biting force measurement radiographic evaluation of terminal abutments.

Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.

Materials and methods: Twenty four patients were selected according to the following criteria: Patients with unilateral mandibular distal extension with last standing second premolar abutment, abutments showed sufficient occluso-gingival height and good periodontal condition. Patients were divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction using "OHIP14" questionnaires and biting force measurement radiographic evaluation of terminal abutments.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral mandibular distal extension area
* The abutments showed sufficient occluso-gingival height of its clinical crown
* Adequate inter-arch space and no tempro-mandibular joint disorders.
* No para-functional habits,
* Full opposing arch or restored with acceptable fixed restoration
* Minimal bone height11 mm at the lower second molar area.

Exclusion Criteria:

\*Insufficent bone height in posterior area of mandible
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING MASTECTOMY PROCEDURES

The objective of this study is to evaluate device efficacy between the HelixAR Electrosurgical Generator (HEG) and Conventional Electrosurgical Coagulation (CEC) Systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery.

The study is designed and powered to demonstrate the superiority of the HEG to CEC in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. Secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. These outcomes will be evaluated in a controlled population undergoing mastectomy procedures.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.

Exclusion Criteria:

1. Advanced refusal of blood transfusion, if necessary;
2. Active systemic or cutaneous infection or inflammation;
3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
4. Uncontrolled diabetes mellitus
5. Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count \< 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
6. Severe co-existing morbidities having a life expectancy of less than 30 days;
7. Currently involved in any other investigational clinical studies that could influence outcomes;
8. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
9. Renal insufficiency (serum creatinine of \> 2.5 mg/dl);
10. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
11. Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.
Assessment of Clinical Trial Experiences of Alzheimer's Disease Patients

Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Alzheimer's Disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Alzheimer's Disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 50 to 80 years of age
* Participant has a diagnosis of Alzheimer's Disease
* Patient has self-identified as planning to enroll in an interventional clinical trial for Alzheimer's Disease

Exclusion Criteria:

* No diagnosis of Alzheimer's Disease confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Clofarabine in Chronic Lymphocytic Leukemia

This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.

The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of chronic lymphocytic leukemia
* Diagnosis of other acute leukemia
* At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy
* Recovered from toxic effects of prior therapy
* Bilirubin no greater than 2 mg/dL
* Creatinine no greater than 1.5 mg/dL

Exclusion criteria:

* Candidate for treatment of higher efficacy or priority
* Pregnant or nursing
Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients

This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas

This study is a randomized controlled trial of statins effect on serum IgG, IgA and IgM level on chronic hemodialysis patients in Bandarabbas. The study is carried out in Hormozgan, Iran. Seventy four patient were randomized either to receive atorvastatin in addition of usual treatment or not. The primary outcomes were serum IgG,IgA and IgM level. The secondary outcome was drug side effects.

Eligibility Criteria:
Inclusion Criteria:

* All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
* Accepting to participate in the study

Exclusion Criteria:

* Refusing to participate in the study
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF

Andrositol® test allows to obtain additional information besides the WHO parameters and to evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two different time points: before the treatment and 30' after the addiction of myo-inositol directly to the semen. The purpose of this study is to evaluate if the responsiveness to the Andrositol® test of a sperm sample can be predictive of its fertilization rate in an ICSI (Intracytoplasmic Sperm Injection) cycle (primary outcome). Secondary outcomes as embryo development, embryo euploidy status and embryo implantation rate will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* male partners of couples undergoing an egg donor cycles

Exclusion Criteria:

* sperm volume lower than 1 ml
* sperm count lower than 5 X 106 /ml
* total sperm motility lower than 10%
Brexpiprazole in Patients With Schizophrenia

To determine the safety and efficacy of brexpiprazole during long-term treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient has completed the lead-in study 14644A.
* The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
* The patient has a clinically significant unstable illness diagnosed during Study 14644A.
* The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Clinical Trial for GNX80 in Intermittent Claudication

This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.

A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 20 years
* Angiographically confirmed peripheral arterial disease
* Intermittent claudication for more than 6 months

Exclusion Criteria:

* Severe impairment of heart, liver, or kidney function
* Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition
* Poorly controlled diabetes mellitus
* Positive pregnancy test
* Planned surgical or endovascular procedures other than for the treatment of IC
Algorithm for Predicting the Unfavorable Course of Sepsis in Children

A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.).

Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.

* analyze biochemical markers and immune status data in sepsis patients and in the comparison group;
* assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients;
* carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome);
* assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process;
* based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.

Eligibility Criteria:
Inclusion Criteria:

* age from 1 month to 18 years;
* confirmed septic process$
* informed consent.

Exclusion Criteria:

* age from 18 years;
* refuse of patient to participate in the trial;
* chronic mental disorders with severe manifestations;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* cachexia of any origin;
* malignant neoplasms.
The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement

Overweight and obesity, understood as an accumulation of abnormal and excessive fat, are the second leading cause of preventable and avoidable mortality in developed countries, with more than 340 million children and adolescents affected by this disease worldwide. As a consequence, overweight and obesity at an early age is already considered a pandemic by the World Health Organization (WHO), with a high incidence in developed countries.

The abuse of new technologies has remained at worrying levels in the post-COVID period, favoring an increase in the adolescent population considered sedentary. In this regard, up to 70% of adolescents show sedentary behaviors, especially affecting the time spent on screens by both males (93.8%) and females (87.2%). Thus, the use of the cell phone has been shown to be a determining factor, since between 10% and 16% of adolescents show a problematic use of this device, affecting, among other aspects, their behavior during their free time.

In recent years there has been an increase in sedentary time among adolescents and a decrease in the practice of physical activity that has favored a greater accumulation of body fat and increased the probability of being overweight or obese. In this context, some studies have tried to encourage the practice of physical activity in the school context in overweight and obese population, being these interventions effective to improve body composition.

However, these interventions also have their detractors, who argue that the hours of Physical Education are too limited to dedicate so much time to a single content, and that the pedagogical component is often overlooked in their implementation. As an alternative to the above, it has been suggested that Physical Education classes could be used to promote interventions that encourage adolescents to practice physical activity in their free time, and mobile applications could be used to monitor the activity carried out by adolescents, but also as an element that generates adherence and enjoyment in this population. Research in this population using these technologies is scarce, therefore, this project aims to determine the effectiveness of a ten-week intervention promoted from the subject of physical education in which a mobile application is used after school hours on physical activity, body composition and fitness in overweight or obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Be a student of compulsory secondary education
* Present an BMI \> 25.0
* Not present any disease or surgical operation that would prevent the performance of the physical tests or the follow-up of the established intervention.
* Complete the questionnaires provided and carry out the established tests in their entirety.
* Have access to any mobile device that allows access to the technological sports applications used in the intervention.

Exclusion Criteria:

* Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety.
* Failure to complete scheduled intervention activities.