cyrilzakka/clinical-trials huggingface dataset:
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
* Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

* Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
* Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
* Previous enrolment in this trial. Further exclusion criteria apply.
Study of Mirogabalin for Central Neuropathic Pain

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo.

\[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (SCI) due to trauma
* American Spinal Injury Association impairment scale A, B, C, or D

Exclusion Criteria:

* Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
* Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
* Major psychiatric disorders within 1 year prior to screening
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger

The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.

This study aims to analyse and compare the effectiveness of metacarpophalangeal joint blocking splint versus relative motion extension splint for trigger finger. This will help us find out which one of the two splint designs is more effective in the management of trigger finger, thus improving treatment outcomes for patients with trigger finger.

Eligibility Criteria:
Inclusion Criteria:

* Trigger finger patient

Exclusion Criteria:

* Diabetes, non-English speaking
Gastroesophageal Reflux Treatment in Scleroderma

The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.


Eligibility Criteria:
Phase 1 SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-GERD

Inclusion criteria:

1. SSc patients aged between 18 and 65 years.
2. Clinically diagnosed as GERD and GERD-questionnaire score \>3
3. Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation

Exclusion criteria:

1. Pregnancy or lactation
2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
3. Present of Barrett's esophagus
4. Bedridden and confined to no self-care
5. Evidence of active malignant disease
6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
7. Present of active infection that needs systemic antibiotic
8. Allergic history of omeprazole
9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study.

Inclusion criteria:

1. SSc patients who completed the phase 1 study.
2. The subjects were defined as PPI-resistance.
3. The subject must be willing to continue phase 2 study.

Exclusion criteria:

1. Pregnancy
2. Present of uncontrolled or severe medical problems
3. Present of active infection
4. Allergic history of alginic acid or domperidone
5. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
6. Chewing difficulty
Ketamin Plus Propofol for Anesthesia Induction

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Underwent adenoidectomy-tonsillectomy surgery
* Age between 3-12

Exclusion Criteria:

* ASA III-IV patients
* Age; under 3 years old
* Age; above 12 years old.
Cobalamin Deficiency - Diagnosis and Therapy

In a retrospective study with existing values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

Generally, cobalamin ist substituted by intramuscular administration. However, oral preparations are also available. Aims of the focus groups are to investigate the awareness of a (potential) deficiency and to identify a therapy for best adherence.

Various diagnostic strategies exist for the identification of a cobalamin deficiency. In a retrospective study with existing serum values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

A cobalamin deficiency can have various causes: Dietary habits (vegetarian, vegan), advanced age, pernicious anaemia, gastrectomy, drug interactions (metformin, proton pump blocker). Therapy is often performed by intramuscular administration of cobalamin. However, oral preparations are also available in very different dosages. Investigators want to investigate with focus groups whether different patient groups are aware of a (potential) deficiency, how cobalamin is actually substituted (with registered or otherwise acquired products) and which therapy would lead to best adherence.

Eligibility Criteria:
Inclusion Criteria:

* potential cobalamin deficiency

Exclusion Criteria:

* refusal to take part in a survey
Observational Study on Obese Patients During General Anesthesia

There is increased frequency of asthma in obese patients. This study is trying to find out if there is a difference in the presence of bronchospasm during anesthesia in obese and non obese patients.

Obese patients come for surgery every day. In this specific population the frequency of asthma is high.

Problems from the respiratory system increase the morbidity, as they are a significant part of perioperative complications.

The frequency and the severity of bronchospasm have not been studied. Any data concerning the bronchospasm will lead to better perioperative management.

In this study the investigators study any sign of bronchospasm during surgery in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* AGE \> 18 AND \< 78 YEARS
* BMI \< 35

Exclusion Criteria:

* MENTAL DISORDERS EMERGENCY SURGERIES
Hydrodissection as a Treatment for Carpal Tunnel Syndrome

This is a pilot study designed to acquire data on the added value of hydrodissection when using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome. Hydrodissection is part of a standard clinical care injection under ultrasound guidance in which the fluid is used to separate the nerve from surrounding structures.


Eligibility Criteria:
Inclusion Criteria:

* Clinical CTS diagnosis with indication for steroid injection as determined by attending physician (if both hands are involved, only the side with the most severe CTS as indicated by electromyography (EMG) will be included) AND
* adult men and women between age 21 and 80 AND
* no more than moderate severity as indicated by EMG AND
* symptoms of numbness or tingling for at least 4 weeks in the median nerve distribution area AND
* classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram AND
* ability to complete English-language questionnaires and clinical evaluations AND
* is reachable by phone for the follow up contact

Exclusion Criteria:

Exclusion criteria are largely based on the premises of only including patients with idiopathic carpal tunnel syndrome without expected interferences of the acquisition of the ultrasound images or corticosteroid treatment.

* Previous Carpal Tunnel Release (CTR) or other volar wrist surgery on the study hand OR known tumor/mass OR deformity of the study hand/wrist OR
* previous history of steroid injection into carpal tunnel OR
* currently taking a steroid medication either regularly or on an as needed basis OR
* any of the following clinical diagnoses or conditions: Cervical radiculopathy; rheumatoid or other inflammatory arthritis, including gout; osteoarthritis in the wrist; renal failure; sarcoidosis; peripheral nerve disease; diabetes, thyroid disease or other metabolic disorder; pregnancy; amyloidosis; or major trauma (fractures or complete ligamentous tears) to the ipsilateral arm OR
* prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Severe Sickle Cell Disease

The purpose of this study is to develop a safe and curative stem cell transplant approach to treating sickle cell disease by assessing the safety of haploidentical hematopoietic stem cell transplantation using αβ+ T-cell depletion for children and adolescents with severe sickle cell disease (SCD).


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin SS, SC, S-β0 Thalassemia, or SO-Arab Sickle Cell Disease
* Between the ages of 2 and 25 years (Stage 1: 10-25 years; Stage II: 2-25 years)
* Lack a fully matched family donor or fully matched unrelated donor register in the National Marrow Donor Program
* Partially-matched family member with hemoglobin AA (normal) or hemoglobin AS (sickle trait) phenotype
* SCD with Severe Phenotype, defined by the following criteria: Neurologic manifestations of sickle disease including cerebral vascular accident (CVA), transient ischemic event (TIA) or abnormal MRI findings suggestive of silent infarct; Two or more episodes of acute chest syndrome (ACS) requiring admission for transfusional or respiratory support including supplemental oxygen within \[two years\] of enrollment in study despite hydroxyurea therapy. Patients who cannot tolerate hydroxyurea and who experience multiple episodes of ACS will also be eligible; History of severe vaso-occlusive (VOC) disease requiring hospitalization and intravenous narcotics on 3 or more occasions per year over the two years prior to enrollment despite hydroxyurea therapy. Patients who cannot tolerate hydroxyurea and who experience multiple episodes of VOC will also be eligible; Other severe phenotype as evidenced by end organ dysfunction related to sickle cell disease.

Exclusion Criteria:

* Karnofsky or Lansky score \< 60%
* Acute hepatitis or evidence of moderate or severe portal fibrosis on biopsy. (Biopsy will be obtained if patient has been on chronic transfusion therapy \> 6 months or has a ferritin \> 1000 ng/ml) or AST or ALT \>5 times the upper limit of normal
* Severe renal impairment (as evidenced by creatinine clearance of \<50ml/minute glomerular filtration rate (GFR) \< 50% predicted normal)
* Cardiac function that demonstrates shortening fraction less than 26% by cardiac echocardiogram or pulmonary hypertension.
* Pregnant Female.
* Lactating female.
* Pulmonary function with baseline O2 saturation \<85% or Diffusing Capacity for Carbon Monoxide (DLCO) on pulmonary function testing (PFT) with a DLCO \<40%.
Descriptive Observational Study ALK-2016-CPHG

Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 years
* Locally advanced or metastatic NSCLC
* Patient ALK gene rearrangement or ROS1 gene rearrangement
* Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
* Patient followed up by a physician in a hospital pulmonary medicine department
* Subject of reproductive age, using an effective method of contraception
* Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.

Non-inclusion criteria

* Patient included within the scope of an interventional therapeutic trial
* Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
* Patient not available for follow-up throughout the duration of the study
* Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.
Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery

To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD).

Laryngoscopy and tracheal intubation can provoke an increase of blood pressure (BP) and/or HR \[1.2\]. This hemodynamic stress may lead to an imbalance between myocardial oxygen consumption and supply and therefore induce myocardial ischemia, which may be endurable in the patients with normal cardiovascular condition but is potential harmful to the patients with coronary heart disease. Thus it is critical to attenuate the cardiovascular stress induced by laryngoscopy and endotracheal intubation in the high risk patients.

Eligibility Criteria:
Inclusion Criteria:

The coronary angiography from each patient showed that lesions exist in at least one main coronary artery

Exclusion Criteria:

a history of reactive airway disease, gastroesophageal reflux, morbid obesity, a known or predicted difficult airway
Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.

Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.

Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 2 and 12 years old
2. ASA I and II
3. Informed consent signed by parents or legal guardians

Exclusion Criteria:

1. Previous exposure to surgery
2. Contraindication to midazolam
3. Patients with developmental delay
4. Patients with significant visual/hearing problems
A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients

The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.

In each arm, patients underwent three monthly loading doses (at Baseline, Week 4, and Week 8). From Week 8, after the patient had received their third injection of study treatment, the visit intervals were determined by the patient's disease activity. If any of the protocol-specified signs of disease activity were present in the study eye, the subsequent injection visit interval was kept at 4 weeks. If none of the signs were present, the subsequent injection interval was extended by 2-week increments up until a maximum of 12-weekly intervals was reached. If there were any signs of disease activity in the study eye, the treatment interval was reduced as specified in the protocol. The planned individual duration of study participation was 24 months.

Eligibility Criteria:
Inclusion criteria:

- Written informed consent.

Inclusion criteria specific to the study eye:

* Diagnosis of active subfoveal Choroidal Neovascularisation (CNV) secondary to wet Age-related Macular Degeneration (AMD);
* Best Corrected Visual Acuity (BCVA) score of 23 letters or more as measured by 3-metre Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts.

Exclusion criteria:

* Pregnant, nursing, or at risk of becoming pregnant during the study;
* Inability to comply with the study or follow-up procedures;
* Recent (3 months) stroke or myocardial infarction; uncontrolled hypertension; hypersensitivity to the study treatments or to fluorescein;
* In either eye: active periocular or ocular infection or inflammation; iris neovascularisation; uncontrolled or neovascular glaucoma; or one or more patch of geographic atrophy (GA) as specified in the protocol.

Exclusion criteria specific to the study eye:

* Prior or current treatment with anti-angiogenic drugs or corticosteroids;
* Other eye conditions as specified in the protocol;
* Any intraocular procedure carried out within 2 months before baseline or anticipated within 6 months following baseline.
Home-based vs. Supervised Exercise for People With Claudication

The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.

This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.

We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.

The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.

Eligibility Criteria:
Inclusion Criteria:

* Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
* Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
* Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test

Exclusion Criteria:

* Absence of PAD (peripheral artery disease)
* Asymptomatic PAD (Fontaine stage I)
* Rest pain due to PAD (Fontaine stage III)
* Tissue loss due to PAD (Fontaine stage IV)
* Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
* Cognitive dysfunction (mini-mental state examination score less than 24)