cyrilzakka/clinical-trials huggingface dataset:
Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation

For many people affected by inflammatory bowel disease (IBD), their quality of life and their ability to participate in their professional and social lives are severely restricted. Rehabilitation measures based on the biopsychosocial ICF model aim to support the restoration of these abilities. Physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (PROs) can be used to assess the success of ICF-based rehabilitation measures and to optimize them. A suitable biomarker to monitor inflammation in IBD patients is faecal calprotectin. In addition, PROs that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. The aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected PROs after a three-week inpatient phase II rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn's Disease or Ulcerative Colitis
* Participation in an inpatient phase II rehabilitation

Exclusion Criteria:

-
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

antibiotic/steroid combination compared to individuals components 15 days of treatment

Eligibility Criteria:
Inclusion Criteria:

* patients having LASIK surgery;
* men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems

Exclusion Criteria:

* Uncontrolled glaucoma or intraocular hypertension;
* Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
* A history of chronic or recurrent ocular inflammatory disease;
* Uncontrolled diabetes mellitus and diabetic retinopathy ;
* Patients with sight in a single eye;
* Iris atrophy in the eye to be operated;
* Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
* Known or suspected allergy or hypersensitivity to any component of study medication;
* A history or any other evidence of severe systemic disease
"Effectiveness of Dual-Wavelength Laser Therapy in Third Molar Extraction Pain, Swelling, and Trismus"

Objective: To investigate the effects of single session dual wavelength low dose laser therapy to be applied after third molar tooth extraction on postoperative pain, edema and physical activities.

Materials and Methods: Thirty-six patients who applied for the extraction of a Class III and position B lower impacted wisdom tooth were included in the study. The patients were divided into 2 groups as laser and control group. Envelope selection method was used for randomization of patients. After the surgery, a single session of double wavelength low-dose laser therapy was applied to the patients. On the 2nd and 7th postoperative days, pain was measured with the VAS scale, edema was measured by face measurements of 3 different points, and quality of life was measured with the modified Posse scale.

Objective and background: Pain, edema, and trismus are common problems after tooth extraction. Photobiomodulation therapy (PBMT) is frequently used as an adjunctive method to reduce these problems. However, there is no consensus in the literature regarding the type, power, session duration, and application frequency of the laser for this treatment method. The aim of this study is to examine the effectiveness of a single-session application of dual-wavelength PBMT (using a 904 nm GaAlAs infrared laser and a 650 nm red laser) on pain, edema, trismus, and the quality of life of patients following impacted mandibular third molar extraction.

Methods: The study included patients whose impacted mandibular third molars were to be extracted for prophylactic purposes. The patients were divided into two groups as the PBMT group and the placebo control group. Pain, swelling, maximum mouth opening, and quality of life parameters of the patients were evaluated.

Eligibility Criteria:
Inclusion Criteria:

ASA I 18-40 years aged

Exclusion Criteria:

Pregnancy Lactating, Anticoagulant or antiaggregant medication Radiotherapy to the head and face area, Allergy to local anesthetics and prescribed drugs
Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.

OUTLINE: This is a phase I study followed by a randomized phase II study.

PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.

RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer

Exclusion Criteria:

* Prior lymphedema in either arm
* Prior history of axillary surgery (except for sentinel node biopsies)
* Prior history of chest/axillary radiation
* Need for bilateral axillary node dissection surgery
* Prior neurologic deficits (either motor or sensory) in ipsilateral arm
* Known allergy to vital blue dyes
* No prior diagnosis of inflammatory breast cancer
* Cannot be pregnant or planning to continue breast-feeding immediately after surgery
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)

This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway

Exclusion Criteria:

* Contraindications of Xamiol® Gel listed in the German package insert
* Pretreatment with Xamiol® within the last 4 weeks
* Systemic treatment of psoriasis
* UV light therapy
4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age 18-65 years
* Eastern Cooperative Oncology Group (ECOG) status \< 2
* Surgery: R0-resection and \>= 10 removed axillary lymph nodes
* M0 by chest x-ray, bone scintigraphy and liver sonography

Exclusion Criteria:

* Polyneuropathy
* Creatinin (serum) \> 1,4 mg/dl; Bilirubin (serum) \> 2,0 mg/dl
* Cardia dysfunction, ejection fraction \< lower normal value of each institution
* Hematopoeitic insufficiency: leucocytes \< 3,5 G/l, thrombocytes \< 100 G/l
* second malignant neoplasia, except curatively treated basalioma of the skin
* Surgery before more the six weeks (42 days)
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Reasons indicating risk of poor compliance
* Patients not able to consent
Coronary Artery Disease and Renal Failure Registry

It is the aim of the multi-centric and prospective registry to analyze in patients with CAD the impact of different grades of renal failure on the outcome and course of the patients and to correlate these with clinical variables.

In particular, the registry has the following objectives:

* prospective consecutive assessment of all patients with coronary artery disease and renal failure in the participating hospitals of the registry
* evaluation of the outcome and course of patients with regard to their different stages of renal failure at baseline
* analysis of the impact of different therapeutic strategies on acute and long-term outcomes
* identification of clinical risk factors, novel biomarkers and genetic markers for an unfavorable long-term outcome


Eligibility Criteria:
Inclusion Criteria:

* Women and men \>= 18 years of age
* Patients with actually performed interventional coronary angiography and there a documented coronary heart disease, defined as at least one documented stenosis \>= 50 % in at least one main coronary vessel (Main steam; RCX; RIVA; RCA)
* European/Caucasian descent (European/Caucasian parents and grandparents)
* Availability of an urine, serum- and EDTA blood sample of the patient
* Documented consent of patients for handling of personal medical data, including a genetic analysis

Exclusion Criteria:

* Patients who have been already recruited into this registry
* Patients with organ transplantations, apart from kidney transplantations
* Immunosuppressive therapy, apart from immunosuppressive therapy after kidney transplantation
* Patients with polycystic renal disease
* Pregnant and breastfeeding patients
* Known malignant tumor
Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Being mechanically ventilated ≥ 24 hours
* Richmond Agitation-Sedation Scale (RASS): 0 to -1
* No vision, hearing, or body movements restriction
* With clear consciousness and ability to communicate in Chinese
* Expected to stay in the ICU \> 96 hours.

Exclusion Criteria:

* Being pregnant, menopausal, or having a night shift within one month before admission to the ICU
* Have developed delirium before enrollment (ICDSC \> 4)
* With acute physiology and chronic health evaluation (APACHE II) score \> 25 after ICU admission within 24 hours
* With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.
Prognostic Factors of Patients With ADHF

To explore the prognostic indicators for patients with ADHF

According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF were diagnosed, and their medical history, laboratory examination and treatment plan were retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes of patients were analyzed to explore the prognostic indicators for patients with ADHF

Eligibility Criteria:
Inclusion Criteria:

* Patients with ADHF diagnosed according to ESC Guidelines for the diagnosis of acute heart failure 2008

Exclusion Criteria:

* disorders of the hematopoietic system, history of cancer and/or previous treatment with chemotherapy, the infection caused by various pathogens, chronic inflammatory conditions, glucocorticoid therapy and/or histories of glucocorticoid use 3 months before the admission and acute myocardial infarction or coronary revascularization within the past 6 months. Also, patients who did not have a differential WBC count or who were lost to follow-up were excluded.
Late Effects of Radiosurgery on Acromegaly Study

Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly.

Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.

Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.

Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject, man or woman, whose age is greater than or equal to 18 years;
* Subject has a combination of defined values plus Insulin Like Growth Factor-1 and no braking growth hormone (\<1.2 milli-International unit/L) during an oral glucose tolerance acromegaly.
* Exposed: Subject with a surgically treated in remission with or without drug treatment somatostatinergic, acromegaly who received treatment with Gamma Knife radiosurgery within not less than 10 years and less than or equal to 20 years.
* Not exposed: Subject with a surgically treated acromegaly controlled by treatment somatostatinergic, not having received Gamma Knife radiosurgery.
* Subjects with thyroid under standardized assessment Levothyrox® inclusion in case of deficit associated thyroid stimulating;
* Topic supported in a project partner services;
* Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol.

Exclusion Criteria:

* Minor or over the age of 75 years subject,
* Subjects with acromegaly resistant to somatostatinergic, or that required power is pegvisomant or cabergoline
* Subjects who received two pituitary neurosurgical treatment or treatment with conventional radiotherapy or radiosurgery treatments 2
* Pregnant or lactating woman,
* Topic is not affiliated with the social security system, or private about freedom;
* Subject refusing to participate in the study or not signing the informed consent;
* Subject with malignant disease known evolutionary
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
* ECOG Performance Status 0 or 1
* No prior palliative chemotherapy

Exclusion Criteria:

* (Neo)Adjuvant chemotherapy if \< 6 months between end of (neo)adjuvant chemotherapy and relapse
* Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
* Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose \> 300 mg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia

Gestational weight gain (GWG) has been closely related to health outcomes, particularly in gestational diabetes mellitus (GDM). Pregnant women may be particularly motivated to make healthy lifestyle changes. Previous studies showed that lifestyle modification interventions (diet and exercise) may be successful in reducing GWG in high-risk women but their effects on the incidence of GDM and other adverse perinatal outcomes have been limited. The research question for the future full randomized trial is whether an optimizing healthy GWG programme focusing on lifestyle (diet and physical activity) feasible to decrease the risk of GDM in a developing country. Thus, this study aims to evaluate the effectiveness of a web/smartphone-based lifestyle program in optimizing gestational weight gain (GWG) to prevent the incidence of GDM.

General objective: To determine the effectiveness of a web/smartphone-based lifestyle program on optimizing gestational weight gain (GWG) to prevent the incidence of GDM.

Specific objectives:

1. To compare changes in the primary outcome (incidence of GDM) between pregnant mothers receiving web/smartphone-based lifestyle program (i.e. intervention group) and pregnant mothers not receiving web/smartphone-based lifestyle program (i.e. control group).
2. To compare changes in the secondary outcomes (GWG, dietary intake and physical activity) between pregnant mothers receiving web/smartphone-based lifestyle program (i.e. intervention group) and pregnant mothers not receiving web/smartphone-based lifestyle program (i.e. control group).

Study location: A total of nine (9) states are randomly selected to represent the Northern, Southern, East Coast and central regions of Peninsular Malaysia. The states are then randomly assigned to either the intervention states or control states. All maternal and child health (MCH) clinics in the top five highest populated districts are purposively selected.

Study design: This is a cluster-randomized, controlled trial (RCT), whereby states as clusters and will be randomly allocated into either intervention or control group. All pregnant women in each cluster will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian women
* At any trimester of pregnancy
* All ethnicities (Malays, Chinese or Indians)
* With or without diseases (diabetes mellitus with/ without insulin, hypertension, dyslipidaemia, overweight/ obese)

Exclusion Criteria:

* Medical diagnosis with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk)
* Severe comorbidities (eg cardiac diseases, kidney diseases severe anemia) that require specific interventions
Assessment of Asthma Control Level in Primary Care Setting in Malaysia

A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.

Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control at the Primary Care Setting in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients.

Eligibility Criteria:
Inclusion Criteria:

* Malaysians who have been diagnosed with Asthma by a physician verified by an investigator and seen at government health clinic (Klinik Kesihatan) from October - December 2017
* Be at least 18 years of age

Exclusion Criteria:

* Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
* Pregnancy