cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* PT within normal laboratory range

Exclusion Criteria:

* The receipt of any investigational drug within 1 month prior to this trial
* Use of anti-coagulation or anti-platelet therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs within 30 days prior to trial
* African-American race
* Weight above or equal to 160 kg
* Recent diagnosis of any illness that would be present concomitant to trial period
Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis

To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.

In patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)

Eligibility Criteria:
Inclusion Criteria:

* Men or women between the ages of 18 and 75
* Clinical diagnosis of autoimmune thyroiditis, serum TPOAb and TGAB positive
* Thyroid function is normal, and no drugs affecting thyroid function such as Umetole and Serge have been used

Exclusion Criteria:

* The contraindications indicated in the Chinese instructions of the drug
* Hypothyroidism, hyperthyroidism
* Liver function impairment
* Renal function impairment
* Claustrophobia
* Mental disorders
Role of Immunoscore® in Stage II-III Colorectal Cancer

The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively.

The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.


Eligibility Criteria:
Inclusion Criteria:

1. Anatomopathological diagnosis of colorectal adenocarcinoma
2. Stage II - III (AJCC 8th edition)
3. Patient undergoing surgery with curative intent

Exclusion Criteria:

1. Current or previous diagnosis (within the last 5 years) of another invasive primary malignant neoplasm, with the exception of non-melanoma skin neoplasm
2. Presence of distant metastatic disease evidenced in imaging tests
Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.

The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit.
* Have an HIV RNA ≥ 1000 copies/mL, at screening.
* Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided.
* That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance),
* Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents.
* Based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new OBT. This is defined as:
* Having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or,
* Having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the OBT not having used raltegravir in the past.

Exclusion Criteria:

* Potentially life threatening (Grade 4) laboratory abnormality or medical condition.
* Severe hepatic impairment (Child-Pugh classification B or C).
* End stage renal disease or other disease states requiring dialysis therapy.
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* Fasting plasma glucose level of \< 240 mg/dL
* Body Mass Index ( BMI )20.0 - 35.0kg/m2
* GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Receiving insulin within 12 weeks before screening
* Diabetic ketoacidosis
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products \[NVP\], heated tobacco products \[HTP\], and nicotine pouch products \[NPP\]), and how the appeal is modulated by relative price, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Eligibility Criteria:
Inclusion Criteria:

* From CA, US, or EN
* At least 21 years old
* Smoking daily
* Smoking mostly or about equal amounts of factory-made cigarettes
* Does not currently vape (for exclusive smokers only)
* Vapes Daily (for dual users only)

Exclusion Criteria:

* There will be no additional exclusion criteria for this study.
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.


Eligibility Criteria:
Inclusion Criteria:

* liver transplantation for hepatitis B induced endstage liver disease
* absence of coinfection with HIV and HCV
* female and male patients \>= 18 years of age

Exclusion Criteria:

* any evidence of other causes for endstage liver disease
* patients that do not fulfill the criteria for liver transplantation
Risk Factor and Outcome of Candidemia

Candidemia is the fourth leading cause of hospital-acquired infection in USA. In CMUH, it caused 9% hospital-acquired bloodstream infection in 2008 and 2009. In addition to increased mortality, candidemia also increased hospital stay and cost. There is a trend of increased cases of candidemia in recent years in CMUH. Early empirical and target treatment can reduce mortality and shortened length of hospital stay.

In the past, most prior studies in Taiwan dealt with risk factors for mortality rather than for candidemia and also focused at in vitro susceptibility to antifungal agents. In this study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated 1000 cases. There were some rare Candida species. Therefore, the investigators hope to do case study for these diseases to provide the epidemiology of candidemia in CMUH. The result can help clinician in predicting the disease and its outcome. Besides, it also provides the epidemiology of candidemia in mid-Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* patient had candidemia from 2002-2010

Exclusion Criteria:

* no
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning.

A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Patients demonstrated significantly worse performance with leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of neglect patients. This difference was significantly reduced during and following treatment. Our objective is to investigate whether Amantadine Hydrochloride is effective in improving allocation of spatial attention and improving function in people with Traumatic Brain Injury.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-50 yrs
2. Patients who were diagnosed with a Diffuse Axonal Injury post TBI
3. Severity of injury was defined as moderate to severe
4. At least 3 months post injury
5. Sufficient cognitive abilities to learn and perform the computerised task.

Exclusion Criteria:

1. Pyramidal signs on neurological examination
2. Localised damage demonstrated on CT
3. Contra indication to Amantadine, post traumatic epilepsy, renal failure and patients with known sensitivity to Amantadine
4. Patients who were diagnosed with Parkinson's disease or has a first degree family who was diagnosed with Parkinson's.
Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa

Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse.

Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.

The aim of this study is to evaluate the effectiveness of Virtual Reality Exposure Therapy in the management of body dysmorphic disorder in patients with anorexia nervosa, compared to the traditionally proposed body approach in psychomotor therapy.

Eligibility Criteria:
Inclusion criteria :

* Female adolescents aged 13 to 18
* with a diagnosis of anorexia nervosa of all types (including purgative and hyperphagic) according to the DSM-V
* French as first language
* agreed to participate in the study
* parental authority holders accepting her participation in the study
* affiliated to a social security system

Patients will not be included in the study:

* with a somatic severity criterion:

  * Total aphagia
  * Body mass index (BMI) \< 14kg/m² for those over 17 years of age, BMI \< 13.2kg/m² for those aged 15-16 and BMI \< 12.7kg/m² for those aged 13-14.
  * Confusion
  * Bradycardia \<40/min, Tachycardia
  * Blood pressure \< 80/50mmHg
  * Hypothermia \<35.5°C
  * Severe metabolic disorders: hypokalemia \< 2.5 mmol/l, hyponatremia \< 125mmol/l or hypernatremia \> 150 mmol/l, hypophosphoremia \< 0.5 mmol/l
  * Acetonuria, hypoglycemia \< 0.6g/l
  * Creatinine elevation \> 100micromol/l
  * Cytolysis \> 4N
  * Leuconeutropenia \<1000/mm3
  * Thrombocytopenia \<6000000/mm3
  * Suicide attempt in the last month before inclusion
  * Receiving benzodiazepine treatment outside the prescription limits.
* Psychotic patients or patients with psychoactive substance addiction according to MINI KID criteria (Sheehan DV et al. Reliability and validity of the Mini International Neuropsychiatric Interview for children and adolescents (MINI Kid). J Clin Psychiatry 2010;71(3):313-326).
Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion

In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success.

expected results:

The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in the need for additional pain relievers compared to the placebo, without interfering with the outcome of medical abortion


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Pregnancy of up to 7 weeks gestation.
* Approval from the Ministry of Health committee for termination of pregnancy after an intrauterine pregnancy was demonstrated by an ultrasound exam.
* Subjects that provided informed consent and agree to comply with all study procedures.

Exclusion Criteria:

* Known allergy to mifepristone, misoprostol, paracetamol or NSAIDs.
* Severe anemia.
* Drug or alcohol abuse
* Known abnormal liver function (liver function tests greater than 1.5 times upper range of normal).
* Known abnormal renal function (serum creatinine \> 1.5 mg/dl).
* Abnormal blood tests
* Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
* Chronic disease
* Patient is participating currently in another clinical trial
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

ADHD is a common childhood disorder associated with concentration problems and disruptive behavior. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

This study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will come in for weekly study visits at which their ADHD symptoms and any side effects will be assessed by self-report rating scales.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD
* Score of greater than 1.5 standard deviation above the age and gender norms on the ADHD-IV rating scale
* Parents and children can understand English
* Parents and children willing to attend all study visits
* Able to swallow study medication
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Severe depression
* History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions
* Use of medications that may interact with the herbal product
* Current use of medications to treat ADHD
* Previous use of Hypericum
* Pregnancy
Shoulder Fracture Interview Study

Shoulder fractures are painful injuries and are the third most common fracture in adults. More and more people are having these injuries each year. Problems such as pain, swelling and lack of movement and strength can last for many months and some people never get back to their previous levels of ability with the injured arm. Information that is given to people following this injury can be very difficult to understand. To improve the information that is given to people following a shoulder fracture, it is necessary to understand what it is like to live with a shoulder fracture and what is important to people recovering from this injury.

This study will interview people who have had a shoulder fracture at around one month and around 4-6 months after their injury. These people will be identified from a physiotherapy waiting list. The interviews will explore people's views on their injury, their recovery and how their needs and priorities change over time.

Previous studies have shown that the written information provided to people after a shoulder fracture is varied and complex, and is written by experts without any apparent input from patients. Appropriate information provided at the right time may lead to improved outcomes for patients after a shoulder fracture, which may mean improvements in pain levels and function. Appropriate information may help to increase patients empowerment, which is their ability to use information provided to enable them to make informed decisions regarding their health care and to take a proactive approach in their recovery following an injury such as a shoulder fracture. To ensure that information is accessible and appropriate, it is necessary to understand the experience of living with a shoulder fracture and what is important to those who have sustained this injury.

This study intends to hear the views of people who have had a shoulder fracture both early on (around one month after injury) and later in their recovery (4-6 months after injury). It aims to explore the differing needs and experiences of people at different time points after injury and how their views on recovery change over time.

This may lead to further work on information provision, which may help improve outcomes by providing the right (accessible) information to the right people in the right way at the right time.

Eligibility Criteria:
Inclusion Criteria:

- Aged 18 years or over

Have sustained a proximal humerus fracture and been referred from East Lancashire Hospitals NHS Trust fracture clinic to outpatient physiotherapy

Able and willing to provide written informed consent, as deemed by the Chief Investigator

Exclusion Criteria:

- Does not meet inclusion criteria
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain


Eligibility Criteria:
Key Inclusion Criteria:

* Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
* Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
* Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)

Key Exclusion Criteria:

* Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
* Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Investigation of the Muscle Oxygenation in Patients With Post COVID-19 Syndrome

More than 60% of patients infected with COVID-19 have long-term symptoms. These symptoms are associated with common ground-glass opacities on computed tomography scans and chest radiographs. The pathophysiology of long-term persistent symptoms is largely unknown, but hypoxia and hypoxic tissue damage, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch, and lung fibrosis caused by COVID-19-associated pneumonia are thought to cause long-term symptoms. Desaturation may occur during exercise due to hypoxia, pneumonia and lung involvement in patients with post-COVID syndrome. Oxygenation of peripheral muscles may decrease due to hypoxemia, but there is not enough study on this subject yet.

Post-COVID syndrome is defined as unexplained signs or symptoms that develop during or after infection with COVID-19 and persist for 12 weeks. Long-term symptoms include fatigue, dyspnea, impaired exercise and lung function.It is important to understand physiological mechanisms underlying persistent dyspnea, fatigue, and impaired exercise capacity after COVID-19 infection to develop appropriate rehabilitation interventions while improving these symptoms. The pathophysiology of long-term persistent symptoms is largely unknown, however hypoxia and hypoxic tissue damage caused by COVID-19-associated pneumonia, decreased pulmonary diffusion capacity, ventilation-perfusion mismatch and lung fibrosis have been hypothesized. The effect of hypoxemia associated with COVID-19 on oxygenation of peripheral muscles and muscle oxygenation at submaximal and maximal exercise intensity has not been investigated, yet.

The aim of our study is to evaluate and compare quadriceps femoris muscle oxygenation in submaximal and maximal exercise tests in patients with post-COVID syndrome.

Patients referred from Gazi University, Faculty of Medicine, Department of Chest Diseases for pulmonary rehabilitation to Cardiopulmonary Rehabilitation Unit located in the Faculty of Health Sciences were recruited, Department of Physiotherapy and Rehabilitation, between March 2022 and May 2023. Muscle oxygenation during six-minute walk test and cardiopulmonary exercise test on two different days was measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75
* Diagnosed with pulmonary involvement COVID-19
* Volunteer to participate in the study

Exclusion Criteria:

* Body mass index \>35 kg/m2
* Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
* Aortic stenosis, complex arrhythmia, aortic aneurysm
* Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
* Cognitive impairment that causes difficulty in understanding and following exercise test instructions
* Participated in a planned exercise program in the last three months
* Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
* Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine