cyrilzakka/clinical-trials huggingface dataset:
Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique

This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.

Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.

Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. Clinical outcomes were measured using the visual analog scale (VAS), American Orthopaedic Foot \& Ankle Society (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner score, and time taken to return to activities. Preoperative and postoperative MRI, the ability to perform heel rise, and complications were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* clinical presentations and physical examination, routine ankle X ray and MRI

Exclusion Criteria:

* calcaneal tuberosity avulsion fractures
* Achilles tendon rerupture
* previous surgical procedure on the affected Achilles tendon
Exercise Intolerance in Renal Failure

Patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. The investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certainly contribute to exercise dysfunction as well as cardiovascular risk. The investigators will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney disease. The investigators will test whether short-term treatment with tetrahydrobiopterin (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease (CKD) stages I, II, and III and do not regularly exercise

  1. CKD Stages I, II, and III will be defined as reduction in estimated glomerular filtration rate (eGFR) to 30-59 cc/minute as calculated by the Modification of Diet in Renal Disease (MDRD) equation, or an eGFR\>60 cc/minute with proteinuria greater than 500 mg/g of Creatinine or 500 mg per 24 hours.
* willing and able to cooperate with the protocol
* CKD patients must have stable renal function (no greater than a 20% reduction in eGFR over the prior 3 months)
* controls will be matched for age, gender, race, and hypertensive status.

Exclusion Criteria:

* severe CKD (eGFR\<30 cc/minute)
* drug or alcohol abuse
* diabetes
* any serious systemic disease that might influence survival
* severe anemia with hgb level \<10 g/dL
* clinical evidence of congestive heart failure or ejection fraction below 35%
* any history of past myocardial infarction or cerebrovascular accident
* symptomatic heart disease determined by electrocardiogram, stress test, and/or history
* treatment with central alpha agonists
* uncontrolled hypertension with BP greater than 160/90 mm Hg
* low blood pressure with BP less than 110/60
* history of nephrolithiasis
* pregnancy or plans to become pregnant
* treatment with vitamin C within the past 3 months
* hepatic enzyme concentrations greater than 2 times the upper limit of normal
* HIV infection
* surgery within the past 3 months
* previous treatment with BH4
* known hypersensitivity to BH4
* any condition that places the participant at high risk of poor adherence or poor follow-up
* patients must be willing to use an acceptable method of contraception if of childbearing age
PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.

Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.


Eligibility Criteria:
Inclusion Criteria:

* Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:

  * Post-PE functional impairment criteria
  * Post-PE Cardiac Impairment criteria
  * Chronic Thromboembolic Disease criteria
* Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE

Exclusion Criteria:

* CTEPH diagnosis
* Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
* Active cancer
* Pregnancy
* Myocardial infarction or cardiac surgery one year prior to inclusion
* Congenital heart disease, congestive heart failure
* History of stroke
* Any previous inpatient or outpatient PR

Additional criteria that are absolute contraindications for pulmonary rehabilitation

* Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
* open tuberculosis
* active infectious diseases and acute inflammatory processes
* Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
* Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
* lack of motivation for therapy
* massive incontinence
* drugs and alcohol addiction
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation

This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.

This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing:

* the immediate safety and technical surgical results of implantation
* the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital
* the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing bilateral lung transplantation
* Signed written informed consent has been obtained prior to any study related procedure

Exclusion Criteria:

* Diaphragm malformation which makes the electrode insertion impossible
* Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
* Participation in other clinical studies that could interfere with the results in the ongoing study
Copy Number Variation in Prenatal Diagnosis

An observed study is aim to map the CNVs distribution in human genome of Chinese prenatal population.

Setting: Prenatal diagnosis center of Taizhou City, Zhejiang Province Patient: total cases of pregnant women needed prenatal genetic diagnosing Methods: karyotype was performed with combined of molecular and cytogenic protocol. Subgroup: molecular karyotyping performed by genomic Chip (CMA) or NGS, the latter including cnv-seq and NIPT.

Main outcome: comparison of CNVs distributions in subgroups. Second outcome: comparison of CNVs distributions in demographic dates.


Eligibility Criteria:
Inclusion Criteria:

* total population need invasival prenatal diagnosis

Exclusion Criteria:

* multipara
RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones

To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Eligibility Criteria:
Inclusion Criteria:

Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy

Exclusion Criteria:

Intrahepatic stones; Malignant tumor disease ;
Combined Effects of Inspiratory Muscles Training With Pilate Training in Asthma Patients

Asthma is a chronic (long-term) condition that affects the airways in the lungs. The airways are tubes that carry air in and out of your lungs. In asthma the airways can become inflamed and narrowed at times. This makes it harder for air to flow out of your airways when you breathe out. When symptoms get worse, it is called an asthma attack. There is no permeant cure for asthma, but medical treatment and physiotherapy treatment can help to manage it. There is many physiotherapy protocols can be used for asthma patients like aerobic exercises, breathing exercise etc. The objective of our study is determine the combine effects of inspiratory muscle training with Pilate training on dyspnea, cardiorespiratory fitness and quality of life in asthma patients.

The randomized control trial will used as study design as study design for this this purpose simple random sampling technique will be used to allocate the sample in two group The sample size will be calculated by the G-power analysis. This study will conduct in Jinnah Hospital, Lahore Group A will receive both inspiratory training and Pilate training and group B receive only Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise .The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front. Pre and post measurement will be done using Juniper asthma quality of life, 6 mint walk test, Borges dyspnea scale and fatigue severity scale to measure the outcomes. Data will be analyzed SPSS version 25. T-test and Regression analysis will be used.

Key words: asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training

To determine the combined effects of inspiratory muscles training with Pilate training on dyspnea, cardiorespiratory fitness quality of life in asthma patients

Eligibility Criteria:
Inclusion Criteria:

* Age range from 30 to 50 (15)
* Both Male and Female
* FEV1 value range from 64% to less than 50%
* Medically cleared for cardiac rehabilitation.
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.

Exclusion criteria

* Status Asthmatics
* Patient with cardiac disease
* Age range from 30 to 50 (15)
* Both Male and Female
* FEV1 value range from 64% to less than 50%
* Medically cleared for cardiac rehabilitation.
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable European Union guidelines.
2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (\>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.

   * For subjects 18 years of age and older, the ICS dose must be \>500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
   * For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

Exclusion criteria:

1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

   * Affect the safety of the patient throughout the study
   * Influence the findings of the studies or their interpretations
   * Impede the patient's ability to complete the entire duration of study
3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers

A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Accepts healthy volunteers

Exclusion Criteria:

* Who has allergy to investigational product
A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old

Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, age 18\~40
* Unilateral, operable, histologically confirmed adenocarcinoma of the breast
* Stage I-III
* Primary surgery with clear margins plus axillary dissection
* Able to start protocol Rx within 8 weeks of surgery
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer: the immunohistochemical cut-off for ER positive status was

  1% or more staining in nuclei
* HER-2 negative (IHC 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy
* pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter \>10 mm when histological grade III, or tumor diameter \>20 mm when histological grade II)
* ECOG performance status 0-1
* Adequate cardiac, renal, hepatic and hematologic function

Exclusion Criteria:

* Metastatic disease
* Bilateral breast cancer (synchronous or metachronous)
* Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
* Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
* HER-2 positive (IHC 3+ OR FISH+) and or triple-negative breast cancer
* Documented history of cardiac disease contradiction anthracyclines
* Concurrent serious illness
* Peripheral neuropathy of CTC grade\>1
* History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
* Pregnancy or lactation
Compression Aided Management of Edema in Patients With C3 Venous Disease

Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.

Research Design: Pilot study of patients presenting to vascular clinic with chronic venous disease with varicose veins and/or edema will be randomized 1:1 in one of two compression garment groups. Measurements of edema and the interface compression applied at the ankle will be determined. The venous clinical severity scoring system and quality of life are assessed. After 4 weeks of treatment patients will have repeat objective studies and clinical outcomes determined.

Methodology: Patients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. Patients eligible for the study will be randomized to knee-high 20-30 Hg graded compression stockings or anti-embolism (13-18 mm Hg) compression stockings. Patients will have limb quantitative edema assessment, a severity score and quality of life determination. Compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. Following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. Data will be analyzed and presented as mean±sd. Data are analyzed using ANOVA followed by Scheffe's F test for comparison of multiple means. Student's t-test for unpaired and paired data will be used for comparison of two means. Differences are considered statistically significant if P \< 0.05.

Significance: Utilizing objective measures of leg edema and applied interface pressure with two different compression garments, the data will provide the important relation between compression (mm Hg) and function of an appropriate graded compression stocking in improving limb edema and symptoms. In addition, measuring clinical outcomes before and after compression will validate the usefulness of proper compression. This study is intended to identify important quantifiable parameters that may be useful in assessing treatment end point including: clinical improvement, length of treatment, daily treatment utilization, prognosis, and clinical guidelines for compression in a specific clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with varicose veins exhibiting lower leg edema
* Unilateral or bi-lateral edema

Exclusion Criteria:

* Generalized leg edema from renal disease, heart failure, liver disease or other undetermined cause
* Acute infection
* Hepatitis
* Steroid use
* immuno-deficiencies including HIV
* Acute deep venous thrombosis
* Have had leg surgery or other orthopedic procedure in past 6 months
Hohenheim Malnutrition Study in Geriatric Fracture Patients

The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 75 years, or
* age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
* written informed consent

Exclusion Criteria:

* progressive cancer disease
* relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
* insufficient German speech intelligibility
Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients

The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients.

Effect of St. John's Wort oil on skin moisture in intensive care patients.

The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.

Research data was collected at Eskisehir City Hospital, between September 1, 2023 and March 1, 2024. Descriptive Characteristics Form, Braden Risk Assessment Scale, Moisture Meter Device and St. John's wort oil were used to collect data. In the sample size power analysis of the study, the total number of samples was found to be 138 with test power ( 1-β) 0.80, α(alpha)=0.05, effect level 0.10. The research was conducted on a total of 140 patients, 70 in the experimental group and 70 in the control group. St. John's wort oil was applied to the experimental group and routine nursing care was applied to the control group for 21 days. Independent Sample t test, ANOVA (Repeated Measures test), Mann- Whitney U test, Wilcoxon test and Pearson-χ 2 cross tables were used to evaluate the data.

Eligibility Criteria:
Inclusion Criteria:

* Admission to intensive care due to internal diseases diagnosis
* The patient is immobile
* The area to be applied is determined as the Coccyx and the tissue in this area must be intact.
* No allergy to St. John's Wort oil
* No circulatory disorders in the applied area

Exclusion Criteria:

* Having a complicated diagnosis such as cancer
* Having any disease that has spread to the entire skin
* Having an allergy to topical medications or plant extracts
* The patient has different variations such as surgical operation and intensive care change (post-operative follow-up patient)
* The patient has a diagnosis of a skin disease such as dermatitis
* A wound in the coccyx area