cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Joint Position Sense in Carpal Tunnel Syndrome

The aim of the study was to investigate the validity and reliability of the KForce Sens® for the evaluation of wrist joint position sense in individuals with CTS. Wrist joint position sense was assessed with KForce Sens® and Baseline® electrogoniometer. The validity and reliability of the KForce Sens® for wrist position sense evaluation were investigated by comparing the two data sets.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate CTS confirmed with EMG
* having symptoms for at least 3 months
* not receiving medical treatment and physiotherapy until 3 months before the study at the latest

Exclusion Criteria:

* having trauma in the affected extremity in the last 6 months
* having cervical radiculopathy
* having brachial plexopathy
* having cognitive problems
* having neurological problems
* being pregnant
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers under Fasting Conditions

Eligibility Criteria:
Inclusion Criteria:

- Healthy adult male volunteers of 18-55 years of age;

* Weighing at least 60 kg within 15% of their ideal weights (Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company 1983)
* Medically healthy subjects with clinically normal laboratory profiles and ECGs;
* Voluntarily consent to participate in the study.

Exclusion Criteria:

- History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

* History or presence of:

  * alcoholism or drug abuse within the past year;
  * hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers;
  * hypersensitivity or idiosyncratic reaction to benazepril HCl, benazeprilat or other ACE inhibitors.
  * angioedema or anaphylactic reaction to any substance;
* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
* Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have vomited, who have experienced diarrhea or who have undergone vigorous and prolonged exercise (without drinking) within 24 hours prior to dosing.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Comparative Assessment of Radioisotope Glucose and Breath Test

This is a research study about improving our diagnostic method for small intestinal bacterial overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study, investigators wish to utilize Nuclear Medicine techniques to locate where the glucose solution that is administered during EAGBT is being consumed by bacteria is in the small bowel when it detects SIBO.

Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention, and diarrhea due to colonization and an excessive amount of bacteria in the small bowel. Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion, the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum. Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses distal SIBO.

Investigators have recently shown that glucose administration into the distal duodenum through upper endoscopy has a higher positive yield for SIBO in patients with negative oral GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the colon, i.e. false-positive test. Study objective here is to administer a radio-labeled glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then determine if the rise in breath hydrogen and/or methane correlates with the location of the isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy. Clinical response to treatment will be assessed on follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent gas, bloating, distension, and suspected SIBO
* Negative oral GBT
* 18 years and older

Exclusion Criteria:

* Pregnancy
* Diabetes
* Previous abdominal surgery except cholecystectomy, appendectomy
* Diet prep non-adherence
* Smoking or exercise causing hyperventilation prior to exam
The NOR-COR Study for Coronary Prevention

The NOR-COR study is a cross-sectional, observational study designed to explore a large number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors (including anxiety, depression, quality of life) in 1369 patients with established coronary heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and laboratory data, and sputum/saliva for genetic analyses will be collected.

The main overall aim of the NOR-COR study is to develop new strategies to improve secondary prevention for underserved high risk patient-groups with CHD. The first study phase aims to collect information necessary to develop empirically based future secondary coronary prevention interventions. In a genetic sub-project markers associated with CHD and personality type will be explored.

The study will evaluate current secondary preventive programs and explore the mechanisms that link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The study will in short term provide new knowledge potentially useful for increasing participation in current cardiac rehabilitation/secondary preventive programs. For a longer perspective these associations may be useful for design of new intervention programs to selected high risk patient groups whom may be in need of programs with different content and/or of longer duration than those currently being applied.


Eligibility Criteria:
Inclusion criteria:

All patients aged 18-80 years with first or recurrent diagnosis or treatments for CHD: a) acute myocardial infarction \[ICD-10; I21\], b) coronary artery by-pass graft operation (CABG), or c) elective or emergency PCI \[ICD-10; I25\]) have been identified from hospital patient discharge lists (diagnostic lists) by searching chronologically after last admission the past three years. In patients with recurrent diagnosis the last event will define the event.

Exclusion Criteria:

* Cognitive impairment that would invalidate assessment including all patients living at nursing home and psychosis.
* Short life expectancy (i.e. \<1 year) due to terminal heart (NYHA class 4), lung (chronic obstructive pulmonary disease GOLD 4)-, liver- or kidney disease (chronic kidney disease stage 5), malignant disease, or other reason.
* Not able to understand and write the Norwegian language or refuse to give written informed consent to study participation.
Re-routing in Treatment High Anal Fistula

The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?

Anal fistula is a very common perianal condition associated with considerable morbidity and inconvenience to the patient. It is hollow tract lined with granulation tissue that connects an in-depth primary opening inside the anal canal to a superficial secondary opening in the perianal skin. It is mostly nonspecific infection of an anal gland in the intersphincteric space as the initiating pathology Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy into intersphincteric, trans-sphincteric, and supra-sphincteric or extra-sphincteric Surgical therapy is the main method used to treat anal fistula. The best treatment criterion is to eradicate the infected lesion, ensure sufficient drainage, and promote the closure of the fistula, while minimizing damage to the anal sphincter.

High anal fistulas require more complex treatment when compared to low anal fistula because of their complexity.

Rerouting is a transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. The newly posi-tioned intersphincteric fistula is then dealt with at a later date when the external sphincter is soundly healed .

The advantages of rerouting over other techniques in patients with high anal fistulae; patients had satisfactory results, decrease recurrence of fistulae or abscess formation. Healing is rapid, short hospital stay and continence to flatus and faeces preserved

Eligibility Criteria:
Inclusion Criteria:- patients with high anal fistula admitted at Asuit University Hospital at the period of study

Exclusion Criteria:- Any case with low anal fistula
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.

Introduction: Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure.

Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement.

Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines
* Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
* Patients should be older than or equal to 18 years of age

Exclusion Criteria:

* Atrioventricular reentrant tachycardia (AVRT)
* NYHA Class = IV
* Left ejection fraction of ≤ 30%
* Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
* Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure
* Contraindication for anticoagulation therapy
* Left atrial diameter \> 7.0 cm
* Preoperative need for intra-aortic balloon pump or intravenous inotropes
* Renal failure requiring dialysis or hepatic failure
* Life expectancy of less than one year
* Pregnancy or desire to be pregnant within 12 months of the study treatment
* Current diagnosis of active systemic infection
* Documented MI 6 weeks prior to study enrollment
Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax

Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy investigating a combination regimen including VEN and DEC.

Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy, investigating a combination regimen including VEN and DEC to improve the survival outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with AML secondary to myeloproliferative neoplasms (sAML), untreated, newly diagnosed, according to WHO 2016 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization
2. Patients unfit for intensive treatment modalities at the discretion of the investigator.
3. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
4. Signed written informed consent according to ICH/EU/GCP and national local laws.
5. Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial

Exclusion Criteria:

1. Diagnosis of de novo AML
2. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin ≥2,5 x ULN and/or ALT\>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with Creatinine Clearance (CrCl) level \<30ml/min (calculated by Cockcroft Gault formula) (unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following adequate supportive measures.
3. Pre-existing HIV positive serology (i.e. already known before enrolment). The participation to the study will require serology testing for HIV positivity at baseline: in case of HIV positivity or refusal to perform HIV testing, the patient will be considered not eligible.
4. Uncontrolled bacterial or fungal infections
5. QTc \>470 msec on screening ECG (Fridericia's formula)
6. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 6 months.
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.

Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age at the time of signing the informed consent.
* A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough.
* Persistent cough for at least the last 8 weeks before screening.
* Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years.
* Ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening.
* Respiratory tract infection within 4 weeks before screening.
* History of chronic bronchitis.
* Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening visit.
* Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway

Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents.

Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with feasible toxicity for MBC patients as a salvage treatment strategy after failure of anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with other salvage agents, especially for patients with HER2 overexpression breast cancers. Additionally, a recent report showed that possible rational background for patients with HER2 mutation-positive breast cancers.

Based on this rationale, the investigators are to conduct phase II single-arm study of poziotinib for patients with MBC who showed refractoriness to conventional treatments as salvage treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic breast cancer with measurable or evaluable disease
2. age ≥ 20 years
3. HER2 mutation or EGFR mutation/gene amplification confirmed by CancerSCAN or Activated AR pathway confirmed by RNA seq \& nCounter assay, AR expression was confirmed by immunohistochemistry(IHC) or EGFR high expression (≥ IHC 2+ \& lower ER / ≥ IHC score + and HER2 2+ or SISH negative)
4. ECOG performance status 0 - 2
5. Two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane
6. Life expectancy ≥ 3 months
7. Progression within 6 months or less of latest chemotherapy
8. The patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiotherapy must be completed 2 weeks before study entry.
9. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
10. Adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or CCr ≥ 50 ml/min)
11. Adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, AST/ALT ≤ 3 x upper normal limit)
12. No prior history of pan-HER TKI including poziotinib for metastatic breast cancer
13. Written informed consent

Exclusion Criteria:

1. HER2-overexpressing breast cancer
2. Serious uncontrolled intercurrent infections
3. Serious intercurrent medical or psychiatric illness, including active cardiac disease
4. Pregnancy or breast feeding
5. Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
6. Documented leptomeningeal brain metastasis
7. Known brain metastases unless treated and stable
8. Peripheral neuropathy ≥ grade 3
9. Prior treatment with pan-HER TKI including poziotinib will not be allowed.
10. Use of any investigational drug within 4 weeks of the study
11. Treatment with chemotherapy or hormone therapy within 3 weeks of the study
Pharyngeal Electrical Stimulation in Amyotrophic Lateral Sclerosis

During the course of ALS most patients develop swallowing deficits. In this pilot study we investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES). PES is Communauté Européenne (CE-) certificated and has been approved for treatment of neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged brain structures. There is evidence of a positive effect of PES in Stroke and Multiple Sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* possible, probable or definite ALS according to the revised El Escorial criteria (Brooks et al. 2000)
* age \>18 years
* able to understand all information and to give full consent according to good clinical practice (GCP)
* moderate ot severe dysphagia, defined by a mean value (all consistencies) of 4

Exclusion Criteria:

* concurrent participation in another interventional trial
* tracheostomy
* severe psychiatric disorder or clinically manifest dementia
* pulmonal or cardial disorder which constitutes a risk when inserting the tube into the pharynx
* permanent cardiac pacemaker or defibrillator