cyrilzakka/clinical-trials huggingface dataset:
Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment

The goal of this study is to identify chemical compounds in the blood and sputum (i.e., biomarkers) that are associated with objective measurements of health status in patients with cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a protein that regulates how the body uses and stores iron, vary during CF pulmonary exacerbation (CFPE).


Eligibility Criteria:
Inclusion Criteria (required at screening visit):

* Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
* History of consistent sputum production on most occasions;
* FEV1% greater than or equal to 75% of best measurement in previous 6 months;
* 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
* Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score \<5);
* Not admitted to hospital within the previous 3 weeks;
* Body weight greater than or equal to 75% of best measurement in previous 6 months;
* Provision of signed informed-consent to study protocol;
* 18\<Age\>65

Exclusion Criteria:

* Women who are pregnant or lactating;
* Subject does not meet Inclusion criteria;
* Recent and/or persistent visible blood in sputum (hemoptysis);
* Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

The secondary objectives of this study are:

* To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
* To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
* To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
* To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery

Exclusion Criteria:

* Inadequate IV access.
* History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
* Less than 18 years of age or Greater than 65 years of age.
* Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.
* Patients with active, clinically significant anemia.
* History or evidence of asthma or heart failure.
* Pregnant.
* Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.
* Refusal to provide written authorization for use and disclosure of protected health information.
* Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.
* Patients with known OSA
Developing and Testing of Culturally Adapted Cognitive Behavior Therapy (CaCBT) for Pashto Speaking Pakistanis and Afghans

CBT for common mental disorders has a strong evidence base in both the USA and the UK. There are wider cultural and linguistic differences between Non Pashtun and Pashtun population of Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need some adaptations when working with clients from non-western background. This study, thus, aims to culturally adapt CBT for common mental disorders for Pashto speaking population in Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small scale pilot study.

The study will be carried out using mixed methods; quantitative and qualitative. Qualitative part will consist of structured interview with a minimum of 10-15 patients; carers; and mental health professionals, respectively, using the interview questionnaires. The data will be analysed by systematic content and question analysis which will identify the emerging themes and categories. The data will then be reorganized into wider themes and categories and written for guidelines to culturally adapt therapy manual for common mental disorders.

Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the effectiveness of a "CaCBT intervention" for Pashto speaking patients. All those who fulfill the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10 RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be included in the study.

The intervention group of the RCT will receive CaCBT intervention in addition to the treatment as usual (TAU) while the control group receives TAU. The assessment will be carried out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory (BSI), Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire (BDQ)/ WHO DAS will be used to measure somatic symptoms, anxiety, depression and disability due to physical and psychological problems, respectively. Schwartz Outcome Scale will be used at follow up to measure the outcome.


Eligibility Criteria:
Inclusion Criteria:

* All those who fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4) or Anxiety disorder using ICD10 RDC and who live within travelling distance of the psychiatry department in Peshawar will be approached. Those patients, who have agreed to enter the study, will be assessed 2 weeks later, to fill in the baseline measures when they attend their first appointment. Patients will be asked to attend a further appointment at the end of study period and will be assessed again.

Exclusion Criteria:

* Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
* Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Participant has participated in a \[14C\]radiolabeled study within the past 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.

This list only contains the key exclusion criteria.
Are Doctors and Assistant Nurses Equally Good at Informing Patients

Objectives: to compare patients' recall of information regarding postoperative self-care when being informed by either doctors or assistant nurses.

Methods: a non-blinded randomized single-center controlled trial being conducted at a hand-surgical unit in Northern Sweden. Included are adult ambulatory patients about to undergo surgery in local anesthesia. Patients are randomized into two parallel groups, with the control-group being informed by doctors and the intervention-group by assistant nurses. Patients will be telephoned one week after surgery for assessment of information recall via a structured telephone-interview.

The study was conducted within the hand-surgical unit at Norrland's University Hospital in Umeå, county of Västerbotten, in Sweden. There are three hospitals in this sparsely populated county of 55432〖km〗\^2 with about 268000 in population. The hand-surgery unit serves both the local population and is a tertiary referral center.

As the healthcare in Sweden is funded by taxpayers, the healthcare for patients is free, apart from a small nominal fee. There was a total of seven doctors and seven assistant nurses participating in the study, all having several years of experience working with hand-surgical care. Prior to the study, doctors had the formal responsibility of informing patients about their postoperative care. However, despite it being the surgeons' responsibility, the task of informing patients was at times performed by assistant nurses. After receiving the information, patients were discharged and left the clinic. Normally patients receive a complementary written information after being informed verbally. Patients included in the study did not receive the written information, since it might have been a confounding factor in understanding of information.

Eligibility Criteria:
Inclusion Criteria:

* about to undergo elective hand surgical procedure in local anaesthesia
* 18 years or older.

Exclusion Criteria:

* does not speak Swedish
* dementia or other form av cognitive impairment
Cryosurgery in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

RATIONALE: Cryosurgery for liver metastases may have fewer side effects and improve recovery.

PURPOSE: Phase II trial to study the effectiveness of cryosurgery for patients with unresectable liver metastases from colorectal cancer.

OBJECTIVES: I. Evaluate the feasibility of conducting a multi-institutional clinical study of cryosurgery for liver metastases. II. Evaluate the morbidity and mortality of cryosurgery for liver metastases when applied in a multi-institutional setting. III. Evaluate the efficacy of cryosurgery for liver metastases as measured by total liver control, local lesion control, and overall survival.

OUTLINE: This is a multi-institutional study. Patients are first confirmed by exploratory laparotomy to have no extrahepatic metastases. They then undergo biopsy of the portal lymph node, after which, full mobilization of liver is recommended. Cholecystectomy is optional but recommended for treatment of tumors adjacent to the gallbladder. After mapping out the location and size of the metastatic tumor by ultrasound, cryoablation of the metastases is carried out. Cryoablation involves the delivery of nitrogen through metallic probes placed surgically into the center of the liver metastases. There are two freeze and thaw cycles for each lesion with synchronous intraoperative ultrasound monitoring of the cryoablation. One centimeter margin of cryoablation is determined by this ultrasound image. Treatment of the liver with regional chemotherapy is not allowed until radiographic and pathologic confirmation of disease progression in the liver. Follow-up is at 3 weeks after surgery and then every 3 months.

PROJECTED ACCRUAL: There will be a maximum of 45 patients accrued in approximately 3 years for this study. This is a two stage accrual design in which 17 patients are first accrued of which 15 should be eligible. If fewer than 11 of the initial 15 eligible patients show no evidence of disease at 3 months, the study stops and treatment is abandoned. If at least 11 patients show no evidence of disease, then 28 additional patients are accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed primary colorectal adenocarcinoma with synchronous and metachronous metastases to liver 1 to 5 liver metastases demonstrated by rapid sequence CT scan or Feridex-enhanced MRI within 2 weeks of registration CT portography not required No single metastasis greater than 6 cm Maximum liver involvement must not be more than 40% by volume No extrahepatic metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Platelet count greater than 80,000/mm3 Prothrombin time less than 15.0 seconds Hepatic: Bilirubin less than 2.0 mg/dL Renal: Not specified Other: Must be disease free for at least 5 years except for treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed No concurrent regional chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.

The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.

78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:

   to. Basal oxygen saturation\> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
3. The patient is hospitalized or meets hospital admission criteria.
4. The patient is not expected to enter the ICU or die in the next 24 hours.

Exclusion Criteria:

1. Participants in another simultaneous clinical trial.
2. Use of other immunomodulators.
3. Coinfection with the hepatitis B virus (detectable AgSup-HBV).
4. Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
5. Presence of laboratory abnormalities of grade ≥ 4.
BioimPEDance of Diabetic Foot Ulcers

The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patient (Type 1 or 2) with diabetic foot ulcer or lower limb ulcer
* written informed consent signed
* insured by the French national health insurance scheme

Exclusion Criteria:

* wound in the similar position on the other limb
* people under legal protection
* unilateral limb oedema
* contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses
* patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.
Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression

To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.

The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.

Not provided

Eligibility Criteria:
Inclusion Criteria:

1. Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:

   1. Radicular pain - below the knee,
   2. Nerve root irritation

   i. positive nerve root tension sign - straight leg raise positive between 30 and 70 degrees, or ii. positive femoral tension sign, or iii. neurologic deficit - asymmetrical depressed reflex or decreased sensation in a dermatomal distribution or weakness in a myotomal distribution.
2. Primary one-level posterolateral herniation in the lower lumbar spine (L4-L5 or L5-S1 only) as shown by magnetic resonance (MR) imaging (protrusion, extrusion or sequestered fragment) consistent with the clinical symptoms (both level and side).
3. The investigator confirms that the patient is a surgical candidate for discectomy,
4. The patient has been scheduled for their surgical procedure no more than two months from time of consent,
5. 18 years to 55 years of age at time of consent,
6. Willing to complete the study requirements and permit agency and sponsor authorized personnel to access medical records,
7. Able to understand oral and written Danish.

Exclusion Criteria:

1. Previous lumbar surgery
2. Cauda equine syndrome
3. Scoliosis greater than 15 degrees
4. Osteoporosis
5. Segmental instability (\> 10 degrees angular motion or \>4mm translation)
6. Vertebral fractures
7. Spinal Infections
8. Spinal tumors
9. Inflammatory spondyloarthropathy
10. Pregnancy or the intent to become pregnant in the following year
11. Comorbid conditions contraindicating surgery
12. Multiple herniations
13. Known allergy to titanium, aluminum or vanadium
14. Female patients of childbearing age, who are not willing to use adequate contraception specified as: intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). It is accepted in certain cases to include subjects having a sterilized permanent partner or subjects using double barrier contraceptive methods which is a condom combined with a diaphragm.
A Clinical Trial for CTD-ILD Treatment

The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).

The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.

Eligibility Criteria:
Inclusion:

1. Subject gives voluntary written informed consent to participate in the study.
2. Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
3. Males and females age greater than 18 years at time of screening.
4. Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.

Exclusion:

1. History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta

This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.


Eligibility Criteria:
Inclusion Criteria:

* The participant and/or his parent/legal guardian is willing and able to provide signed informed consent, and the participant, if less than (\<) 18 years of age, is willing to provide assent if deemed able to do so
* Participant is male and has been treated with agalsidase alfa at 0.2 mg/kg q2w for the 12 months prior to switching to agalsidase beta
* The participant has a confirmed diagnosis of Fabry disease by alfa-galactosidase A (alfa-GAL) activity and/or genotyping per local standards
* The participant when switched to agalsidase beta receives the labeled dose, that is, 0.9 to 1.1 mg/kg (1 mg/kg) q2w, and must be willing to maintain the labeled dose for the duration of the study

Exclusion Criteria:

* The participant is on dialysis or is post renal transplantation
* The participant is in end-stage cardiac failure
* The participant and/or his parent or legal guardian, in the opinion of the investigator, is unable to adhere to the requirements of the study
* The participant has been switched from agalsidase alfa to agalsidase beta and does not have historical blood and urine samples
Comparison of Removing and Non-removing Patellofemoral Joint Osteophytes Following Medial Unicompartment Knee Arthroplasty

Background: Anterior knee pain (AKP) is a challenge following unicompartmental knee arthroplasty (UKA). Some surgeons remove patellofemoral joint (PFJ) osteophytes to reduce osteophyte impingement and AKP. However, there is evidence that PFJ osteophytes compensate for knee osteoarthritis (OA) by increasing and improving stability and increase contract surface area in knee osteoarthritis. Moreover, when PFJ osteophytes are not removed, some studies report good clinical outcomes. The issue of removing or leaving PFJ osteophytes is controversial.

The objective of this study was to compare AKP following mobile bearing UKA after removing or leaving PFJ osteophytes.

Methods: The prospective non-randomized study included 89 isolated medial osteoarthritis (OA) of knee. They were classified into 2 groups. Group (Gp)1 was removing PFJ osteophytes; consists of 44 knees. Gp2 was non-removing PFJ osteophytes: consists of 45 knees. The patients were follow up and recorded incidence of AKP and VAS for AKP at 6 weeks, 3months, 6 months, 1 year and 2 years. No patients were lost to follow up. The patellar tilt and shift were measured at 6 weeks, 3months, 6months, 1year and 2 years via skyline view radiography. The knee society scores, Oxford knee score, knee injury and osteoarthritis outcome score, forgotten joint score and Kujala scale also were recorede at 6 weeks, 3months, 6months, 1 year and 2 years.

Removing and non-removing osteophyte at patellofemoral joint is controversial topic. The osteophyte may help to reduce load and improve stability of patellofemoral joint. Therefore, the purpose of this study is to compared anterior knee pain between removing and non-removing osteophyte at patellofemoral joint following medial mobile bearing unicompartmental knee arthroplasty

Eligibility Criteria:
Inclusion Criteria:

* age \> 42 years old
* range of motion \> 90 degrees
* flexion contracture\< 15 degrees
* normal function of anterior cruciate ligament

Exclusion Criteria:

* spontaneous osteonecrosis of the knee
* inflammatory joinr arthritis
* full thickness cartilage loss at lateral compartment