cyrilzakka/clinical-trials huggingface dataset:
Development of the ICF Based Amputee Mobility Scale

Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral and traumatic lower limb loss
* Prosthesis use for at least 6 months

Exclusion Criteria:

* Not speaking or understanding Turkish
* Not having cognitive skills to perform the tests
Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients

This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with a post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 at Visit 2 (day -7)

Exclusion Criteria:

* Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
* Patients requiring long term oxygen therapy
* Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
* Other protocol-defined inclusion/exclusion criteria may apply
Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection

The purpose of this study is to validate a noninvasive prenatal diagnosis procedure for genetic conditions in the developing fetus by analyzing fetal genetic material present in the pregnant mother's blood.

Amniocentesis (drawing fluid from inside the womb) and chorionic villus sampling (removing a very small amount of the developing placenta) are the current "gold standard" for diagnosis of genetic abnormalities in the developing fetus (unborn child) during the pregnancy. However, these procedures have small risks of miscarriage and are normally used for women with known risk factors for a genetic condition in the fetus. Finding a method to detect genetic changes in a fetus without performing a procedure associated with a risk for miscarriage may be helpful for the clinical care of pregnant patients in collaboration with their providers in the future.

It has been demonstrated that cell-free fetal (cff) DNA is present in the mother's bloodstream. This is already used to detect common conditions like Down Syndrome, a condition that all pregnancies are at risk for. The existing cffDNA tests are not currently able to detect if a fetus is a carrier or affected with the conditions parents are commonly screened for using carrier screening and other genomic tests. The study aim to test the use of new genetic techniques on cffDNA that can find if a fetus is affected with condition that one or both parents are carriers for. The study also aim to investigate if these new tools can detect other spontaneous and inherited genetic changes. This will make prenatal detection possible of many more genetic disorders than can currently be done by drawing blood from the mother. The Maternal and Paternal blood samples will be also used for the development of new methods to detect genetic abnormalities in the developing fetus.

Eligibility Criteria:
Inclusion Criteria:

General:

* Parental age≥18
* Singleton pregnancy
* Willingness and ability to provide informed consent to participate in study
* Patient having a diagnostic procedure (CVS, amniocentesis, cordocentesis) or delivering on site (obtain cord blood/cord segment)

Main Study:

* Gestational age: 10-23 weeks
* Parents are both carriers of different known pathogenic SNVs or short indels (\<=5bp) in the same gene (compound heterozygosity).

Substudy:

* Gestational age ≥10 weeks
* Either parent or both carry a known structural variant and/or other chromosomal anomalies AND/OR Ultrasound highly suggestive of an underlying genetic aberration (e.g., cardiac outlet and 22q)

Exclusion Criteria:

* Any Multiple gestation is excluded (MCDA, DCDA, triplets, etc)
Risk and Risk Perception of Knee Osteoarthritis in the US

The investigators have created an interactive knee osteoarthritis (OA) risk calculator that estimates a user's risk of developing symptomatic knee OA as well as the user's risk for undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk. Participants were randomized to either access general information about OA or use the risk calculator in addition to accessing general OA information. The investigators hypothesized that participants randomized to the risk calculator arm would have more accurate perception of their knee OA risk and would have increased willingness to change risky behavior compared to the general OA information group.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 25 and 45
* Participants must live in the United States
* Participants must not be diagnosed with osteoarthritis

Exclusion Criteria:

* All participants who did not meet the inclusion criteria
Efficacy of Electroacupuncture on Acute Abdomen Emergency Care

Contrast to conventional Western medicine, traditional Chinese medicine is the most common used therapy of complementary and alternative medicine. Taiwan inherits traditional Chinese culture, and the people popularly accept traditional Chinese medicine for general diseases. However, most patients with acute or critical illness are used to admit to emergency department for medical services, and then transfer to the department of related specialist for further treatment. During the course of staying at emergent observation room, some diseases do not meet the criteria of admission and keep for evaluation. The longer of staying at emergent observation room the more waste medical resources.

The Chinese medicine department of Changhua Christian hospital has treated patients, who consulted us at their own dispense, with subjective discomfort but remained at the emergent observation room. Detailed contents of this study include the Chinese and Western medicine, pharmaceutical, nursing cooperation mode, monitoring clinical effect of treating of the patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting, abdominal pain, abdominal distension or constipation.And the patients were assigned to the control and treatment group. Then we give the treatment group with the electroacupuncture treatment,and the control groupe with the Chinese medicine seeds and the transcutaneous nerve stimulation (no power).The patients were diagnosed with objective analysis of tongue diagnosis, pulse diagnosis, heart rate variability, and questionnaire of pain. Hope that we can assess the efficacy of both two different treatment,and also assess the cost of medical care, and try to complete the syndromes statistical analysis of traditional Chinese medicine for abdominal pain, building the relevance of Chinese medicine physical assessment teaching and clinical efficacy.

The most important of this clinical teaching is that, this is a good opportunity for Chinese medicine and Western medicine to cooperate with each other at the emergency department to confirm the efficacy of traditional Chinese medicine, not only in the field of chronic or geriatric diseases, but also in the field of emergency with the evidence base. This factually achieves communication and integration of Chinese and Western medicine, and benefits the public.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 20-90 years old,who accepted to enter this trial
2. The patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting, abdominal pain, abdominal distension or constipation.
3. ICD-10 is R101-R1012

Exclusion Criteria:

Does not meet the above conditions
A RCT of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for GA

The purpose of this study is to determine whether the compound lidocaine cream is effective in preventing postoperative agitation in patients with endotracheal intubation for general anesthesia.

This is a randomized controlled study. Some parameters were provided by preliminary test, provided theα=0.05,and β=0.20, the sample size can be estimated to be 2000 by the Open Epi Version 2.Patients will be recruited on the basis of predefined criterias. A researcher will take charge of the recruitment. Participants provide written consent and no financial incentives are provided. They are divided into experimental group and control group randomly. We need to collect their basic information including ages, genders, heights, weights, underlying diseases, surgical procedures and levels classified by ASA. Blood pressure, heart rate and other vital signs during the tube drawing process will be recorded. All the contents needed to be recorded had been compiled into a watch list with detailed instructions for filling in. All the personal information and observation records of participants will be kept in secret and only used for research. Developing standard operating procedure and training all the researchers. A third party will assess the accuracy, completeness and representativeness of registry data. Experimental data will be analysed with the help of statisticians.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18
* selective operation patients with endotracheal intubation for general anesthesia

Exclusion Criteria:

* highly sensitive to local anesthetics of amide derivatives or anything else in compound lidocaine cream
* congenital or idiopathic methemoglobinemia
Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma

The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.

Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years old.
* Severe persistent asthma according to GINA.
* Inhaled corticosteroids and long-acting ß2 agonist (LABA).
* Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable.
* Asthma Quality of Life Questionnaire (AQLQ) \< 7
* Asthma Control Test (ACT) \< 19
* ≥ 2 exacerbations in last year

Exclusion Criteria:

* History of cigarette smoking with \> 15 pack/years.
* Other respiratory diseases.
* Comorbidity that can justify the symptoms of the patients.
* Life-threating unstable asthma.
* Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)
Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk

The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

1. BMI \> 20 and \< 37
2. LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
3. TG level \< 150 mg/dL

Exclusion criteria include:

1. self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
2. high alcohol consumption (≥ 14 drinks/week)
3. intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
4. treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
5. vegetarian diet
6. weight loss or gain ≥ 10% body weight in the previous 6 months,
7. lactation, pregnancy, or desire to become pregnant during the study
Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Completed a medical screening questionnaire
* English speaking
* No allergies to the drugs
* Able to complete the forms
* If a woman of childbearing age, agree to use contraception

Exclusion Criteria:

* History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)
* Use of any medication that would contraindicate benzodiazepine administration
* Pregnant or nursing
Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination with Post-engraftment Anti-thymoglobin As Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.

This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.

Eligibility Criteria:
Inclusion Criteria:

1. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
2. normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
3. ECOG: 0-2;
4. Life expectation ≥3 months;
5. Informed consent provided.

Exclusion Criteria:

1. Pregnancies
2. active hepatitis (HBV-DNA≥1×103 copies/ml);
3. active infection require anti-biotics;
4. HIV infection
A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients

The study proposes that addition of high protein plant based diet will improve serum albumin as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient will be provided additional food items to help improve their nutritional status.

The purpose of this study is to improve the albumin and nutritional status of patient with ESRD on dialysis. Serum albumin is a marker to show how well the patient's overall nutrition is. When albumin level drops it signifies poor outcome in dialysis patients both in terms of complications as well as mortality. Our goal on dialysis is to improve serum albumin level as close to normal as possible. This study intends to also improve phosphorus level by adding high protein sources which are plant based. In this study we intend to add certain plant based food items which are high in protein content. Studies have shown that these particular food items considerably increase serum albumin level but at the same time they are safe as they do not increase the phosphorous levels in kidney patients. Patients will be provided the additional food items and all their nutritional parameters will be monitored at baseline and during the study period of one month

Eligibility Criteria:
Inclusion Criteria:

* ESRD Patients on dialysis with an albumin of \<4.0 with the ability to consent and willingness to enroll in the study

Exclusion Criteria:

* Other exclusions include

  * liver cirrhosis,
  * cardiac cirrhosis,
  * dysphagia due to an old Cerebrovascular accident / muscular dystrophy,
  * Hyperkalemia (\>5.5)
Changes in Pituitary Iron and Volume With Deferasirox

Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.


Eligibility Criteria:
Inclusion Criteria:

* Currently on chronic transfusion therapy.
* Duration of chronic transfusion \>1 year.
* Age 2 to 25 years
* On deferasirox monotherapy for the duration of the study.
* Informed consent from legal guardian and/or patient.
* On deferasirox for a minimum of 3 months at start of study.

Exclusion Criteria:

* Sickle cell disease or sickle-beta zero genotype.
* Combination of deferasirox and another iron chelator.
Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.

Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
* 16-50 years old
* preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
* Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1
* ASA（American Society of Anesthesiologists score） ≤ 2
* Heart ejection fraction( EF)≥ 50%

Exclusion Criteria:

* refusing to participate in clinical trials
* A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
* BMI ≥ 25 kg/m\^2
* other not suitable situations