cyrilzakka/clinical-trials huggingface dataset:
Effect of a Thin Customized Insole in RA

50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the forefoot are most frequently afflicted. Studies shows that foot problems can influence negatively on the walking function, physical activity and quality of life. Different foot orthoses and insoles are used as an intervention. Studies find that different insoles do have effect on pain, but there are no or minor effect on walking ability. The literature reports a further need for research and indicates the importance of studies on the effects of cost-effective insoles for patients with RA.

Custom-built insoles takes time and are often expensive, and many patients, especially women, do not wear them since they often do not fit the shoes they prefer to wear. In this study, a 4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side is customized to provide support for the transverse and longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily customized and ready for use the same day. The purpose of this study was to determine whether this insole can reduce foot pain and increase walking distance in patients with RA and forefoot pain.

An experimental study was performed on patients with RA and forefoot pain in either one or both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles (situation A) and without insoles (situation B). The order of situation A and B was randomized, and the assessor was blinded for the order of the two situations. Both tests were conducted the same day. After each test round, the patient was asked to register pain in the foot and perceived exertion. A telephone interview was conducted one year after the effect study to examine whether the insoles were still being used.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis Rheumatoid Arthritis
* Foot pain while walking
* Positive Gaenslens sign in forefoot
* Native Norwegian speaking

Exclusion Criteria:

* Cognitive dysfunction
* Problems reading
* Problems in walking due to problems han the foot such as in ankel, knee or hip
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.


Eligibility Criteria:
Inclusion criteria:

* Healthy males \& females
* Part 1 ages 18-60
* Part 2 ages 18-50 \& 65-80
* Within normal weight range given your height
* Negative urine drug and alcohol test
* Willing to follow all study procedures

Exclusion criteria:

* Any significant abnormal lab, ECG, medical or physical exam finding during screening
* Allergy to the study drug
* Excessive alcohol intake
* Positive HIV or hepatitis B or C result
* Use of prescription or non-prescription drugs within one week of study start except for birth control
* Blood pressure meds \& Tylenol
* Pregnant or lactating women
Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.

Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.

BM(bone marrow) samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* patients with relapsed acute leukemia
* patients with acute leukemia in the third（or more）complete remission (CR3) status

Exclusion Criteria:

* pregnancy women
* uncontrolled severe infection
Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.

Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).

Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years at the time of consent.
* Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
* Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.

Exclusion Criteria:

* Patients with cervical esophageal carcinoma.
* Prior radiotherapy with fields overlapping the current esophageal cancer.
* Patients with cT1a disease.
* Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
* Patients with distant metastatic disease.
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
The Norwegian Cerebral Venous Thrombosis Study

The NoCVT study will investigate CVT (2014-2023) in a large Norwegian population (\> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of CVT.

A retrospective hospital-based chart review will be conducted at 13 different hospitals covering all four health regions and more than 3 million inhabitants in Norway. These 13 hospitals are Akershus University Hospital, Haukeland University Hospital. Oslo University Hospital (Ullevål), Sørlandet Hospital Kristiansand, Drammen Hospital, St.Olavs Hospital, Nordlandsykehuset Bodø, University Hospital of North Norway, Innlandet Hospital Lillehammer, Tønsberg Hospital, Telemark Hospital (Skien), Molde Hospital and Stavanger University Hospital.

A search will be made in the clinical database for patients with the relevant diagnosis of CVT in the period between January 1, 2014, and December 31, 2023. Data from hospital charts will be linked with data from Statistics Norway (SSB), FD-Trygd, and Norwegian Prescription Database (NorPD). Using this combination of clinical data and health registries will make it possible to describe risk factors, clinical and radiological presentation, treatment and short-term outcome in a large Norwegian CVT cohort.

Further, data from hospitals will be linked with data from SSB, FD-Trygd, NorPD, Norwegian Patient Registry (NPR) and Cause of Death Registry (DÅR) up to five years after CVT. Using this methodology will make it possible to investigate overall long-term prognosis and outcomes in terms of mortality, health care utilisation, medication use and working situation up to five years after CVT in a large Norwegian cohort.

Lastly, a prospective follow-up study will include patients that have been diagnosed with CVT at the NoCVT hospitals during 2019-2023. By combining the collected data from the retrospective hospital chart review with the new follow-up interviews and self-reported questionnaires it will be possible to describe quality of life, vocational outcomes, psychological distress, depression, insomnia and disease-related disability in CVT.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals

Exclusion Criteria:

* none
Multicenter Rehabilitation Study in Acute Stroke

The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.


Eligibility Criteria:
Inclusion Criteria:

* first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2)
* time since onset of stroke no more than 10 days
* Functional Ambulatory Category (FAC) 0-3
* voluntary movement in the leg of the affected side
* Barthel Index (BI) 25-75 points- no unstable cardiovascular disease
* Body Mass Index (BMI) \<32
* no severe malposition of joints
* no severe cognitive or communicative disorders
* no other health-related or social barriers to participate intensive rehabilitation

Exclusion Criteria:

* ICH, or MRS \>2
* time since onset of stroke more than 10 days
* FAC \>3
* no voluntary movement in the leg of the affected side
* BI \<25 or \>75
* severe malposition of joints
* severe cognitive or communicative disorders
Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

The current diagnostic criteria for schizophrenia and other psychotic disorders are relatively broad and lack precision. Therefore, distinct diseases may be grouped together under the same diagnostic category, although these diseases may differ according to their clinical expression, prognosis and perhaps their physiopathological causes.

We think that identifying subforms of psychotic disorders that are more homogeneous will better enable to understand their respective physiopathological causes and find personalized treatments.

This study will compare two subforms of psychotic disorders that have been clinically distinguished in the 1970s. These phenotypes have however not been validated yet using scientific investigations.

Using clinical assessments, cognitive evaluations and neurophysiological measures (fMRI) investigating the domains of affect and psychomotoricity , we expect that these two subforms will differ on their clinical, cognitive and neurophysiological characteristics, namely: hebephrenia will be associated with deficits on the affect markers , and respect psychomotoricity (catatonia scales, tests assessing movement planification) whereas the opposite pattern will be observed for periodic catatonia.


Eligibility Criteria:
Inclusion Criteria:

* for both patients and controls
* male or female willing to participate and who have signed up the legal document
* under the protection of health insurance for patients only
* schizophrenia or schizo-affective disorder according to the DSM-5 criteria
* periodic catatonia or hebephrenia accordin to WKL classification
* clinically stable for at least 2 months
* in or out patients for controls only
* no psychiatric history

Exclusion Criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (epilepsia, brain injury, brain surgery...)
* current substance use disorder (DSM-5)
* current major depressive disorder (DSM-5)
* mental retardation (IQ \< 70)
* pregnancy, breast feeding
* current legal control
* contra-indication for fMRI for controls only psychotropic intake during the last 3 weeks
Treatment for Bile Duct Cancer in the Liver

The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Histological or cytological diagnosis of cholangiocarcinoma
* Disease not amenable to surgery
* Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed)
* Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable)
* ECOG PS 0-1
* At least one measurable disease lesion according to RECIST v 1.1
* Life expectancy of 12 weeks or longer
* Adequate hematological, renal and hepatic function
* Platelet ≥100 x 109
* ANC ≥ 1.5 x 109
* Bilirubin ≤ 30µmol/L
* Albumin ≥ 30g/L
* ALT ≤ 3 ULN
* INR ≤ 1.5
* Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

* Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively \> 5 years prior to study entry are permitted.
* Patients with extra-hepatic disease other than regional lymph node metastases.
* Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment
* Biliary obstruction with no possibility of drainage
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Prior treatment of chemotherapy for the cholangiocarcinoma
* Prior radiation therapy to the upper abdomen
* Complete thrombosis of the main portal vein
* Tumor volume \> 50% of the normal liver volume
* Allergy to non-ionic contrast agents
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-006)

The purpose of this phase III, open-label study is to determine the safety and tolerability of cyclosporine in the treatment of dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dry eye syndrome

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the study
* Pregnancy or lactation
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).

It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.

Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm.

The patients are followed for 12 months after completion of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Subarachnoid hemorrhage (SAH) within 72 hours
* Ruptured aneurysm confirmed by angiography of CT angiography
* Fisher grade 2-4
* Hunt \& Hess grade 2-4
* Aneurysm is secured
* Ability to obtain informed consent

Exclusion Criteria:

* Pregnancy
* Allergy to IV contrast or to any component of SCS system
* Non-aneurysmal SAH
* Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
* Coagulopathy
The CARING Study: Creating and Restoring Health Through Nutrition Guidance

The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.

Among Blue Cross Blue Shield subscribers, individuals with type 2 diabetes will be randomly selected and invited to participate in an interventional trial. A control group matched for relevant variables will be selected from Blue Cross Blue Shield subscribers.

The Intervention group participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks. Body weight, plasma lipids, HbA1C, dietary intake and adherence, and food acceptability will be assessed at baseline and at 16 weeks. Their longer-term medical utilization will then be tracked for another 2 years and compared with that of a control population selected from Blue Cross Blue Shield subscribers. Weekly classes will be offered for the whole 2-year follow-up period. Plasma lipids and HbA1C will be assessed every 6 months during the 2-year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
2. Male or female
3. Age at least 18 years
4. Have a diagnosis of type 2 diabetes
5. Ability and willingness to participate in all components of the study, including:

   1. Following a plant-based diet for the initial 16 weeks of the study;
   2. Attending weekly online classes for the initial 16 weeks of the study; and
   3. Keeping physical activity level consistent throughout the initial 16 weeks of the study.

Exclusion Criteria:

1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
2. Smoking during the past six months
3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
4. Current or unresolved past drug abuse
5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period
6. Unstable medical or psychiatric status
7. Cancer diagnosis
8. Chronic kidney disease, stage 4 or 5
9. Evidence of an eating disorder
10. Lack of English fluency
11. Bariatric surgery in the last 6 months
12. Dementia
13. Institutional custodial care
14. End of life
15. Palliative Care
16. Actively engaged in specific BCBSM diabetes programs and case management programs