cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy

Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.

There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.

Eligibility Criteria:
Inclusion Criteria:

Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )

1. Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
2. Symptom duration of minimum 3 months.
3. Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:

   * Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop \& Veer, 2003)
   * Painful arc during active abduction (Ombregt, Bisschop \& Veer, 2003)
   * Positive Neers sign (Neer, 1972 ; Tennent, Beach \& Meyers, 2003)
   * Positive Jobes test (Jobe \& Moynes, 1982 ; Tennent, Beach \& Meyers, 2003)
   * Positive Hawkins-Kennedy impingement test (Hawkins \& Kennedy, 1980)

Exclusion Criteria:

1. Shoulder pain due to trauma, e.g. fall.
2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder
3. History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
4. Full thickness rupture of rotator cuff tendon
5. OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
7. Subjects suffering from serious psychiatric illness.
8. Subjects unable to understand English or Norwegian.
9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
Acupuncture Therapy for Knee Osteoarthritis

Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needles are placed into the body at specific points. Studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). However the evidences of acupuncture for KOA are contradictory. According to the review, intensive acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with one session a week. Moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with KOA.


Eligibility Criteria:
Inclusion Criteria:

1. Age 45-75 years old, male or female
2. Single / bilateral knee pain, duration of more than 6 months
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
4. NRS ≥ 4

Exclusion Criteria:

1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.)
3. History of arthroscopy within 1 year or intra-articular injection within 4 months
4. History of receiving acupuncture or massage treatment within 3 months
5. Severe acute/chronic organic or mental diseases
6. Coagulation disorders (such as hemophilia, etc.)
7. Cardiac pacemaker, metal allergy or needle phobia
8. Pregnant women, pregnant and lactating women
9. Participation in another clinical study in the past 3 months
A Randomized Controlled Trial of ACT-P Versus T4C for Community Reentry

The purpose of the proposed study is to determine the efficacy of Acceptance and Commitment Therapy for prisons (ACT-P) and Thinking for a Change (T4C) as reentry programs in a randomized controlled trial (RCT).

The proposed study will focus on medium to high risk adult males, currently institutionalized and approaching release, who will be randomized to Acceptance and Commitment Therapy for prisons (ACT-P) or the Thinking for a Change (T4C) program. ACT-P is a cognitive behavioral treatment that targets acceptance and mindfulness processes to reduce criminal behavior, and has been adapted for the prison setting. T4C is a widely used and well-established traditional cognitive behavioral program that targets changing criminal thinking.

The first aim of the study is to test the relative efficacy of the ACT-P intervention, compared to T4C, on recidivism. Recidivism will be measured in 3 ways: rearrests, reconvictions, and reincarceration during the 3 years post-release. A secondary aim is to test the theory of change and the proposed mechanisms of ACT-P and T4C. By focusing on the mechanisms that account for program success, it will provide insight into the theory of change underlying each program. Based on the theories underlying each treatment, we hypothesize differences in mechanisms of action between the two treatments. Given the emphasis in T4C on cognitive change, we predict stronger mediation effects in T4C for reductions in antisocial/criminal thinking. In contrast, we hypothesize that increases in psychological flexibility would be stronger mediators for ACT-P than for T4C.

Eligibility Criteria:
Inclusion Criteria:

* deemed medium or high risk according to the Iowa Risk Revised
* eligible and appropriate for cognitive programming as determined by normal operating procedures

Exclusion Criteria:

* court-mandated to either program
Peritubal Infiltration of Bupivacaine in PCNL

Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years of age
* Single PCNL track

Exclusion Criteria:

* Spinal Disc Prolapse
* Any previous renal surgery
* Complication secondary to PCNL

  * Hydrothorax that requires intervention
  * Pneumothorax
  * Massive hemorrhage that requires more than 1 U transfusion
  * Conversion to open procedure.
The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations

The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.

During fetal life, the CNS undergoes major changes, so it is important to study the evolution of brain morphology serially during intrauterine life.

Despite numerous data in the literature, prenatal ultrasound diagnosis of CNS malformations is often difficult due to the presence of imaging pictures that are nondiagnostic or difficult to interpret. Moreover, only some of the sonographic features of CNS malformations have been described in detail. Therefore, it is essential to study and describe the ultrasound pictures in order to identify new ultrasound patterns useful to identify the fetal malformation more clearly. Therefore, this study aims to retrospectively analyze the ultrasound images of fetuses with established brain malformations and compare them with those of healthy fetuses in order to highlight the presence of new ultrasound patterns, which may more clearly define the malformative pathology.

Ultrasound images routinely performed in pregnancy in fetuses with brain malformation and in healthy fetuses will be reviewed.

For each patient, information will be collected on:

* Age
* Previous pregnancies and their outcome
* Pregnancy arising spontaneously or through Medically Assisted Procreation techniques
* Family history of congenital malformation
* Type of central nervous system malformation (neural tube defects, holoprosencephaly, corpus callosum agenesis, cerebellar malformations, posterior cranial fossa cysts, other malformations)
* Gestational age at the time of diagnostic suspicion
* Gestational epoch at the time of diagnosis
* Pregnancy outcome (miscarriage, voluntary termination of pregnancy, spontaneous delivery or cesarean section)
* Presence of associated abnormalities affecting other anatomical districts

For each newborn, information will be collected on:

* Sex
* Weight
* Umbilical artery pH
* APGAR index at 5 and 10 minutes
* Neurological assessment in the immediate postpartum period
* Perinatal mortality

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years with single pregnancy and fetus with ultrasound diagnosis of central nervous system malformation (group A)
* Women with single pregnancy and normoconformed fetuses (group B).

Exclusion Criteria:

* Twin pregnancy
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.

Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.

Eligibility Criteria:
Inclusion Criteria:

Surgical:

* Medically fit for major pancreatic surgery
* No evidence of metastases
* No prior resection
* Arterial involvement limited to a single major vessel and is resectable
* Tumour-free margins could be achieved
* Acceptable length of vessel
* Mass considered otherwise resectable by current standards

General:

* Less than 70 years old
* Performance status \<=2
* Has pancreatic adenocarcinoma
* Adequate bone marrow and organ function
* Therapeutic heparin is allowed
* Taking chronic erythropoietin are permitted
* Not pregnant
* Agree to use contraception
* Able to provide written consent

Exclusion Criteria:

Surgical:

* Aortic involvement
* Involvement of 2 major arterial trunks
* SMV/portal venous occlusion, cannot be reconstructed
* Extensive venous involvement, no arterial involvement
* Disease progression on neo-adjuvant treatme

General:

* Concurrent cancer diagnosis
* Other malignancies unless all therapy completed, no disease for \>=3 years
* Prior radiotherapy or chemo within 1 year, to pancreas
* Bone marrow transplant/stem cell rescue
* Major surgery \<4 wks prior
* Distant metastases
* Renal dysfunction
* Pulmonary insufficiency
* History of cardiac disease
* Active systemic infection(s) or any other related illnesses
* Known HIV, HBV, HCV
* History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy
* Conditions interfering with patient participation
* Known or suspected allergy to study drugs
* Pregnant or breast-feeding
* Therapeutic coumadin
* More than or equal to Grade 2 pre-exiting peripheral neuropathy
UCAN: Uniting Couples in the Treatment of Anorexia Nervosa

UCAN is a research program funded by the National Institute of Mental Health and is part of the UNC Eating Disorders Program. UCAN aims to help couples work together in the treatment of anorexia nervosa. Couples participate in UCAN over a period of six months and return for follow-up treatment three months after the end of the original six-month period. Patients receive weekly individual therapy, monthly psychiatry consultations, monthly dietary consultations in addition to being randomized to one of two types of weekly couples therapy. Participation in UCAN can help participants gain new confidence in facing anorexia as a team and can help us understand how best to involve partners in the treatment of eating disorders.

Patients receive comprehensive eating disorder treatment at the UNC Eating Disorders Outpatient Program in addition to couples therapy. Eligibility: Participants may be eligible if they are 18 or older, have anorexia nervosa and are currently living with a partner with whom they have been in a committed relationship for at least a year. The partner must also be willing to enter treatment.

Eligibility Criteria:
Inclusion Criteria:

* Anorexia Nervosa,
* 18 years or older,
* BMI 16 or higher,
* In a committed relationship with a partner for 1 year or longer and currently living together.

Exclusion Criteria:

* Alcohol or drug dependence in past year,
* Current significant suicidal ideation,
* Developmental disability that would impair the ability of the participant to benefit from the intervention,
* Psychosis,
* BMI less than 16.
PHOENIX: Craving Management Smartphone Application

The objective of this study is to evaluate the effectiveness of the addition of nursing follow-up and the PHOENIX application, a personalized and self-adaptive Smartphone application, on the management of craving in patients with addictive disorders followed on an outpatient basis.

Addictive disorders are a public health priority. The management of addictive disorders aims to reduce addictive behaviour or abstinence, implying that the patient can overcome the urge to engage in this behaviour, a symptom called craving.

Craving, as a major motivational substrate for addictive behaviour, is a preferred therapeutic target for the management of addictive disorders. However, to date, there are no fully effective drugs or psychological interventions. Smartphone applications seem to have an interest in this context, with many advantages: accessibility, anonymity, ease of access and low cost. Sainte Anne's Hospital Moreau de Tour facility (Paris, France) was one of the pioneering centres in the management of addictive disorders. The nursing team has developed expertise in this field. Patients report difficulties to nurses about managing their craving on their own, and ask for more frequent interviews or even daily support. During practice analysis meetings, caregivers sought innovative solutions to optimize this care. Our team has designed the PHOENIX application, which allows us to support patients in real time who wish to reduce or stop their addictive behaviours. Used between two consultations, it targets craving, without being specific to a product or addictive behaviour. When the patient has a craving, PHOENIX identifies the situation and proposes the most appropriate strategy to avoid using. Strategies are personalized and self-adaptive. The application allows caregivers to monitor patients' progress and progress.

Hypothesis of this study: The PHOENIX application used as a complement to nursing care will allow a better management of craving and a decrease in relapses compared to usual care (usual care: multidisciplinary care including nursing care).

Eligibility Criteria:
Inclusion Criteria:

* Being 18 and 65 years old, any sex
* Speak and read French
* Have a Smartphone (Android operating system or IOS)
* Present an evaluated addictive disorder in a structured clinical interview (MINI, adapted to the criteria of DSM-5: substance use disorder according to DSM-5 and bulimia nervosa; National Opinion DSM Screen (NODS), adapted to the criteria of DSM-5: pathological gambling; NODS, adapted to the diagnostic criteria proposed by Carnes: sexual addiction ; MINI)
* Be followed on an outpatient basis
* Prior informed written consent of the patient or his or her legal representative
* Benefit from a French social protection system

Exclusion Criteria:

* Have a current untreated and/or unstabilized psychiatric disorder (assessed by MINI)
* Have a severe cognitive impairment assessed during the clinical interview, which does not allow you to focus your attention or use the working memory required by the application.
* Pregnant or breastfeeding women
* Participant in another clinical trial
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or components.
* Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (\>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study

1. to determine the feasibility of utilizing a wearable device
2. to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device.

This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data.

Scheme and Outcomes: Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study.

Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey.

Note: Vest is a Class I Exempt FDA-registered device.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CVCs ages 0 to 12 years of age
* May currently utilizing or historically utilized the interventional wearable protective device
* Caregiver or parent available
* English and Spanish speaking subjects

Exclusion Criteria:

* • Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.

  * Patients in critical care services such as neonates, trauma/ neurology intensive care unit, or cardiac intensive care unit. Justification: These patients are not mobile with their CVC and not the targeted population.
Bioavailability of Red Wine Anthocyanins

The main aim of this study is to evaluate the bioavailability of table red wine and young Port red wine anthocyanins in healthy men.

Anthocyanins (ANT) are water soluble pigments found in plants, flowers and fruits that are consumed as part of the human diet, many times in higher amounts than other flavonoid classes. Red wine is also an important source of anthocyanins, especially Mv3glc.

Several epidemiological studies have suggested that the consumption of anthocyanin-rich foods, including the moderate consumption of red wine, is positively associated with the prevention of cardiovascular heart disease.

It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising after absorption takes place.Therefore, studying the bioavailability of red wine ANT is very important to identify which metabolites (originated in vivo) can actually reach the target organs (and in which concentrations) and may be responsible for the postulated health benefits of red wine.

Intervention protocol:

Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of table red wine or 150 ml of young Port red wine and blood samples will be collected 15, 30, 60 and 120 min after wines ingestion. Another urine sample will be collected at 120 min.

Table red wine 12 % (250 ml) and young Port red wine 20 % (150 ml), two different food matrices rich in ANT, provided the same amount of ethanol (24 g of ethanol).

A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Age 18-65 years
* BMI \< 25 kg/m2
* Willing and able to provide written consent

Exclusion Criteria:

* Subjects with current or previous CVD, diabetes or other severe chronic disease
* Subjects under prescription of any chronic medication
* Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
* Subjects involved in any clinical or food study within the preceding month