cyrilzakka/clinical-trials huggingface dataset:
Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction

The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.

Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in-vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria Stage II PTTD

  * Swelling
  * Pain with Palpation along the tendon
  * Rearfoot eversion
  * Pain single leg heel raise
  * Flexible flat foot deformity
  * Able to walk 15 m
  * \> 40 years of age

Exclusion Criteria:

* Unable to walk 15 m
* Symmes-Weinstein monofilament test 5.06 mm
* Inflammatory arthropathies (e.g. rheumatoid arthritis, psoriasis)
* Co-morbid foot conditions (e.g. hallux rigidis, plantar fasciitis)
* Inability to assume a STN posture
Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome

Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST).

Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.

Study design: An observational case-control study.

Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an existing database.

Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.

Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has been diagnosed with abdominal complaints, matching ACNES:

   * Patient had a constant site of tenderness that is superficially located with a small (\<2cm2) area of maximal tenderness.
   * The most intense pain could be localized with the tip of one finger.
   * Tenderness increased by abdominal muscle tensing (Carnett's test).
2. has been treated (successfully and unsuccessfully) for ACNES.
3. Patient is at least 18 years old on the day the informed consent form will be signed.
4. Patient is willing and able to comply with the trial protocol.
5. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria:

1. Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
2. Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
3. Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
4. Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
5. Female patient is pregnant during the course of the study.
Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia

Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high recurrence risk and a rapid, occult progression to cardiovascular disease after delivery. There is a critical need for effective interventions to reduce these risks. This is a pilot randomized controlled trial of a novel postpartum lifestyle intervention compared to women who take home blood pressure measurements and women with usual care who are overweight and obese in the first year after preeclampsia. The investigators hypothesize that the intervention will lead to improved weight loss and blood pressure in the first year postpartum, which has broad implications for future pregnancy and long-term cardiovascular health.

The overall objective of this study is to conduct a pilot trial of an internet-based lifestyle intervention and home blood pressure monitoring in the year after delivery among overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to assess the effect of the intervention. The investigators hypothesize that compared to usual care, an internet-based lifestyle intervention implemented in the immediate postpartum period in overweight and obese women with preeclampsia improves weight loss at one year postpartum. 150 overweight or obese women with preeclampsia will be randomized into internet-based lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring alone, or usual care groups in the postpartum period. The investigators will assess feasibility by the proportions of women who are eligible, enroll, and remain in the study at one year. The effect of home blood pressure monitoring on blood pressure and progression to sustained hypertension will also be explored. A successful outcome of this study would have a direct impact to improve cardiovascular health and future pregnancy health in women who have had preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* pre-pregnancy body mass index ≥25 kg/m2
* diagnosed with preeclampsia or gestational hypertension
* access to internet

Exclusion Criteria:

* multiple gestation
* medical co-morbidities: chronic kidney disease, active liver disease (acute hepatitis, chronic active hepatitis), active cardiac disease, pre-pregnancy diabetes mellitus, chronic hypertension diagnosed prior to pregnancy
* pregnancy prior to randomization
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.


Eligibility Criteria:
Inclusion Criteria:

* Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
* Eligible subjects must:

  * Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
  * Not be current candidates for stem cell transplantation or other disease modifying therapies.
* Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
* Life expectancy ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor.
* History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
* Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
* Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Fish Oil and Inflammation in Overweight Subjects

The aim of this study is to investigate the effects of acute and short-term intervention with fish oil on inflammatory markers in overweight subjects.

Being overweight is associated with metabolic syndrome, cardiovascular disease, and diabetes mellitus (type 2). Adipose tissue can be regarded as an active organ, which produces an array of inflammatory mediators. This creates a state of chronic low-grade inflammation. Inflammation has been proven to be a key element in the development of atherosclerotic plaques.

The marine n-3 polyunsaturated fatty acids (PUFAs) have beneficial effects on cardiovascular disease. These effects are partly attributed to the anti-inflammatory effect of the n-3 PUFAs.

Previous studies have shown an anti-inflammatory effect of n-3 PUFAs in overweight subjects, but the studies have been conducted with a high daily dose of n-3 PUFA. We want to examine the effect of a lower dose of 1 g n-3 PUFA/day (the dose recommended by the Danish Heart Foundation).

The study is randomized, placebo-controlled and double blinded. Fifty subjects aged 30 - 75 years (postmenopausal women; waist circumference \> 80 cm and men; waist circumference \> 94 cm) will be included.

Blood samples and fatty tissue biopsies will be collected at baseline, after 1 day and after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥ 80 cm (females) or ≥ 94 cm (males)
* Postmenopausal (females)

Exclusion Criteria:

* Daily intake of fish oil capsules
* Daily intake of NSAIDs
* HbA1c ≥ 8%
* Serum creatinine ≤ 30 mL/min
* Chronic inflammatory disease
* Other serious illness
* Inability to informed consent
Pinhole Versus Tunnel for Soft Tissue Recession

This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.

Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.

Eligibility Criteria:
Inclusion Criteria:

* between 18-75 years old
* have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
* American Society of Anesthesiology class I and II
* full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%

Exclusion Criteria:

* sites of gingival recession around teeth that are non-salvageable
* presence of any exudate, infection or local inflammation around the area to be grafted
* pregnant or breastfeeding females
Schizophrenia Study In Adults

A Placebo Controlled Study For Patients With Schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Patient must meet diagnostic criteria for schizophrenia.

Exclusion Criteria:

* Patients with other psychotic disorders.
* Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
* Patients with a history of autistic disorder or another pervasive developmental disorder.
* Patients with epilepsy or a history of seizures requiring treatment.
* Patients who are excluded from taking the drug risperidone.
* Patients who pose a current serious suicidal or homicidal risk.
* Patients who are adequately stabilized on their treatment.
Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -

To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia Plus DR have an effect on the occurance of AF in patients with no prior history of AF

This multi-centre, randomized, cross-over, prospective study will evaluate the occurrence of AF with AF pacing therapies programmed on (APP and VRR) and with AF therapies programmed off (APP and VRR) in patients with no known prior history of AF (all patients have a pacing indication). The occurrence of AF as well as time to first event and AF burden (frequecy and duration).

Eligibility Criteria:
Inclusion Criteria:

* No prior history of AF or atrial flutter, primary indication of SSS or AV block for dual chamber pacemaker, confidentiality agreement signed and dated before implant, available for follow-up at the study centre where they were enrolled at the protocol defined intervals, willing and capable of participating in all testing associated with the study, on stable regime of arrhythmia management drugs.

Exclusion Criteria:

* Documented history of AF or atrial flutter, clinically significant ventricular arrhythmias, \< 18 yrs old, life expectancy \< 1 year or expectation of heart transplantation during the study period, likely to or have received a mechanical tricuspid valve during the study, enrolled in other cardiovascular studies, women who are pregnant, inability or refusal to sign Patient Confidentiality Agreement, inability or refusal to complete the follow-up schedule at the study centre in which they were enrolled, exhibit arrhythmias due to reversible cause eg, digitalis toxicity, hypoxia, transient electrolyte imbalance, acute myocardial infarction or electrocution.
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients

Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.

In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.

Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented stage I or II head and neck cancer

Exclusion Criteria:

* Karnofsky performance score of less than 60
* Multiple primary head and neck cancer
* History of cancer
* Severe cardiovascular disease
* Inadequate renal, hepatic or hematologic function
* Anticoagulant therapy
* Pregnancy
* Average daily supplement intake of beta-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively.
Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo

This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
* Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
* Capable of giving informed consent

Exclusion Criteria:

* Diagnosis of segmental vitiligo
* Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
* Use of any prohibited medication within the indicated period before the first dose of study drug
* Pregnant or lactating females
* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
* The subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer).
* Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results
* History of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. In accordance with the diagnostic standards of DSM-IV \& ICD-10 for addicted and DSM-IV for abstinence.
3. Qualitative urine detection for opioids showing positive result.
4. Cleared for 8 to 36 hours after their last drug taking.
5. Fully understood and signed on informed consent.

Exclusion Criteria:

1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
3. Patients with serious infectious disease.
4. Patients with history of serious neurological or psychiatrical diseases.
5. Person with history of HIV infection or serious malnutrition.
6. Dependent upon and addicted to multiple drugs.
7. Attended some other drug trials within one month.