cyrilzakka/clinical-trials huggingface dataset:
Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear Imaging

The purpose of this study is to test the safety of the peptide and antibody and at the same time evaluate the tumor imaging of a two step antibody technique in nuclear imaging.

Colo-rectal cancer has an incidence of 8000 cases per year in The Netherlands. Eventually 50% of them will die as a consequence of this disease.

Treatment consists of resection of the primary tumor, followed by adjuvant chemotherapy in some patients. The chemotherapeutical agents, however, are only moderately effective with regard to increase of survival. New treatment modalities are therefore desirable.

Radioimmunotherapy using radioactive labelled antibodies have proven to be effective in hematologic malignancies. Due to slow absorption in solid tumors however an effective radiation dose is not yet achieved.

The aim of our study is to bypass this slow tumor uptake by the use of pre-targeting. We therefore use an unlabeled bispecific antibody infusion. This will be followed several days later by the infusion of a radiolabeled peptide that binds to the bispecific antibody.

We hypothesise that this small peptide will be readily absorbed by the tumor which is pre-saturated by the bispecific antibody. As a consequence a higher radiation dose can be given with a lower toxicity.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Histologic or cytologic diagnosis of colorectal cancer
* Karnofsky performance status \>70%

Exclusion Criteria:

* Pregnant or lactating women
* Severe anorexia
* Active second primary malignancy
* Chemotherapy or radiotherapy within four weeks of study entry
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females at least 18 years old at screening
2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
3. Chronic hepatitis C, genotype 1 infection
4. Males must be surgically sterile or agree to practice acceptable forms of birth control
5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
4. Confirmed presence of hepatocellular carcinoma
5. History of solid organ transplant
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

The study design is an observational cohort study of patients undergoing standard of care oral cavity reconstruction. An observational study is required to prospectively evaluate microbial and antibiotic mechanisms underlying surgical site infection after oral cavity reconstruction.

This is a single institution study at the Medical College of Wisconsin, given the feasibility of projected sample size accrual as well as the clinical and translational expertise at this location for investigating surgical site infection after oral cavity reconstruction. Biospecimens collected will include oral, nasal, pharyngoesophageal, and skin microbial swabs, blood, and discard tissue samples obtained during standard of care oral cavity reconstruction surgery and an oral swab and nasal swab obtained post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Provide signed and dated informed consent form. Subjects must have the capacity to consent for themselves.
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Aged 21 years or older.
4. Planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered.
5. Oral cavity reconstruction surgery will be defined as any surgical procedure which includes a planned connection from the oral cavity to the neck soft tissues which is repaired with a free or regional tissue flap.
6. History of oral or oropharyngeal cancer.

Exclusion Criteria:

1. Allergy to ampicillin/sulbactam.
2. Vulnerable populations including pregnant women and prisoners.
Inspiratory Muscle Training in Cerebral Palsy Patients

To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in cerebral palsy patients to improve respiratory strength and spirometric parameters. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - peak expiratory flow (PEF), forced expiratory volume in first second (FEV1) and clinical evaluations. The participants will be evaluated at the beginning and end of the intervention period. Intervention: There are two groups of patients, one works with low loads (20% MIP) and another with high loads (40% MIP). They train 5 days/week 10 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.

The study was a controlled, randomised, double-blind trial and with allocation concealment. The study protocol was approved by the Bioethics Committee of the University of Salamanca (number of registry 678, 6th October 2021).

Participants:

Institutionalized people with cerebral palsy between 35 and 64 years were included, they were all members of ASPACE Salamanca.

All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.

The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.

Intervention:

"High-intensity group". The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).

The intensity of the device will be 40% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.

"Low-intensity group".The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).

The intensity of the device will be 20% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy patients
* Understand the objectives and be able to complete questionaires

Exclusion criteria: the presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate \> 150 beats per minute (bpm), systolic blood pressure \> 140 millimeters mercury (mmHg) or diastolic blood pressure \> 90 mmHg).
NAC- NAFLD and Cushing

Cushing's Syndrome is a rare disease resulting from prolonged exposure to high levels of circulating cortisol. Clinical manifestations are variable but many patients present a metabolic syndrome (abdominal obesity, insulin resistance, dyslipidemia, hypertension). With regard to the liver, experimental data have shown that excess cortisol leads in an increase in lipogenesis and a reduction in the oxidation of fatty acids. This, in association with an accumulation of visceral adipose tissue and deregulation of adipokines, may contribute to the development of hepatic steatosis in animals. However, few data is available in humans with only one study of 50 patients with Cushing's syndrome estimating the prevalence of hepatic steatosis at 20%.

NAFLD (Non-Alcoholic Fatty Liver Disease), is defined as the presence of hepatic steatosis in the absence of secondary causes of intrahepatic fat accumulation. It is a heterogeneous disease ranging from simple liver steatosis, whose prognosis is generally considered to be benign, to inflammation (NASH, Non-Alcoholic Steato-Hepatitis) which may progress to fibrosis, cirrhosis and an increased risk of hepatocellular carcinoma. The prognosis for NAFLD is mainly related to the severity of hepatic fibrosis.

In Cushing's syndrome, normalization of cortisol production is the most effective strategy to improve co-morbidities associated with hypercortisolism. However, some of these complications, especially the metabolic co morbidities, could not be completely reversible and no data is available about resolution of hepatic steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Active Cushing's syndrome

Exclusion Criteria:

* Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
* Contraindication to MRI
Amoxicillin Clavulanate in Treatment of Acute Otitis Media

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute otitis media
* Age 6 - 35 mo

Exclusion Criteria:

* Spontaneous perforation of the tympanic membrane and drainage
* Systemic or nasal corticosteroid therapy within 3 preceding days
* Antihistamine therapy with 3 preceding days
* Oseltamivir therapy within 3 preceding days
* Allergy to amoxicillin/penicillin
* Tympanostomy tube present in tympanic membrane
* Clinical evidence of infection requiring systemic antimicrobial treatment
* Documented Ebstein Barr virus infection within 7 preceding days
* Down syndrome or other condition to affect middle ear infections
* Known immunodeficiency
* Vomiting or another symptom to violate per oral dosage
* Poor parental co-operation due to language or other reasons
* Use of any investigational drugs during the 4 preceding weeks
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.


Eligibility Criteria:
Key Inclusion Criteria:

Participants must meet all of these criteria for inclusion in the study:

1. The participant has completed written informed consent.
2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
4. Participant must have had inadequate response to antidepressant treatment.
5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
6. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
7. Participants must be willing and able to comply with all study procedures.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
2. Participant has an unstable medical condition or unstable chronic disease.
3. Participant has a history of neurological abnormalities.
4. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD.
5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
6. The participant has an alcohol or substance use disorder.
7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.
Tracking a Tactile Signal Along the Nervous System

Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

-right-hand dominance for participants who are neurotypical

For Aim 1:

-age range of 18-23

For Aim 2:

* participants who are neurotypical will be a similar age to the participants with stroke
* participants who are neurotypical will have no musculoskeletal and neurological conditions
* participants with stroke will have a single stroke incident resulting in a unilateral lesion (ischemic and hemorrhagic)
* participants with stroke will be in the chronic phase (\>1 year from stroke onset)
* participants with stroke will have an onset of stroke after the age of 18
* participants with stroke who meet the criteria of having the capacity to provide informed consent, regardless of aphasia

Exclusion Criteria:

* minors
* pregnant women
* prisoners
* adults not capable of consenting on their own behalf.

For Aim 2:

* participants with stroke who have used antispastic injections in the past six months
* participants with stroke who have a lesion in the brainstem and/or cerebellum
* participants with stroke who have a stroke arising due to brain surgery
* participants with stroke who have hemineglect
From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.

The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.

Further study details are provided by Departement V, Odense University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients for elective lobectomy
* 18 years or older at the day of the operation
* Satisfactory abilities to speak and read danish

Exclusion Criteria:

* Previous Thoracical Surgery.
* Patients with diseases in the nervous system.
* Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder.
* Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.
Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86.

Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.

A case non-case study using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includes more than 18 million reports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967. Information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities (MedDRA) terms will be perform.

Eligibility Criteria:
Inclusion Criteria:

* case reported in the World Health Organization (WHO) database of individual safety case report to 11/20/2018
* Patient treated with at least one bDMARD prescriptions
* adverse events reported were including the MedDRA terms

Exclusion Criteria:

* Chronology not compatible
Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot

Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot.

A pilot, random research with 10 participants was undertaken. Two groups, Experimental group and Control group, were randomly selected among the subjects. Participant completed the informed consent form before the navicular drop test and Harris Mat was used to measure the foot pressure. Footcore exercises and conventional therapy was given for four weeks ,twice a day for 6 days. While the Control group just received conventional treatment, the Experimental group combined Footcore exercise with it. The data will be analyzed using SPSS 26.0 software.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals having flat feet.
2. those with a height difference of ≥ 10 mm during the navicular drop test.
3. No history of foot or ankle surgery.

Exclusion Criteria:

1. Any lower limb injury
2. Healing fracture of lower limb33
3. Any neuromuscular disorder 25
4. Recent surgery
5. Any open wound.
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures

SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 60 years of age at screening.
2. Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
3. Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
4. Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
5. Prior to fracture, patient was able to ambulate using a cane or unassisted
6. Medically stable to undergo either surgical or non-surgical treatment of index fracture.
7. Patient is willing and able to provide written informed consent
8. Patient is mentally able to comply with study protocol requirements

Exclusion Criteria:

1. Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
2. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
3. Sacral fracture potentially or definitely related to tumor
4. Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
5. History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
6. Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
7. Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
8. Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
9. Known allergy to titanium or titanium alloys
10. Current local or systemic infection that raises the risk of surgery.
11. Known or suspected active drug or alcohol abuse, including opioids.
12. Patient lives or plans to move more than 100 miles from the site during the course of the study.
13. Current enrollment in another investigational clinical trial related to fractures or osteoporosis