cyrilzakka/clinical-trials huggingface dataset:
Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke

This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic infarction within 15 days
* Admission NIHSS item 5 score equal to or \>2 -Able to give informed consent, with surrogate consent acceptable-

Exclusion Criteria:

* Pre-stroke modified Rankin Scale score equal or .3
* Pregnant or lactating
* Taking an SSRI on admission to SRH
* Taking a medication likely to have adverse interaction with an SSRI
* Unable to return for follow-up testing days 90,180
* Concurrent medial condition likely to worsen patient's functional status over next 6 months
* Unable to competently participate in testing for 45min-2hrs with rest breaks
* for MRI substudy: contraindication to MRI
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Participant is pregnant and ≤10 weeks gestation at the time of enrollment
* Participant must have been on stable, maintenance dose certolizumab pegol (CZP) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician
* Participant expects to continue CZP therapy throughout pregnancy and for at least 12 weeks postpartum
* Participant has a negative interferon gamma release assay (IGRA) or tuberculin skin test (TST) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. Participants with documented Bacillus Calmette-Guérin (BCG) vaccine and at low risk for tuberculosis (TB) may enroll without having a TB test performed

Exclusion Criteria:

* Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:

  1. Known active TB disease
  2. History of active TB involving any organ system
  3. Latent TB infection
  4. High risk of acquiring TB infection
  5. Current nontuberculous mycobacterial (NTM) infection or history of NTM infection (unless proven to be fully recovered)
* Study participant is taking a prohibited medication or has taken a prohibited medication
* Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
* Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
* Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant
Cerebro Spinal Fluid Collection (CSF)

Cognitive neurodegenerative diseases are a major public health issue. At present, the diagnosis of certainty is still based on anatomopathological analyses. Even if the diagnostic tools available to clinicians have made it possible to improve probabilistic diagnosis during the patient's lifetime, there are still too many diagnostic errors and sub-diagnostic in this field. The arrival of biomarkers has made it possible to reduce these diagnostic errors, which were of the order of 25 to 30%. This high error rate is due to different parameters. These diseases are numerous and often present common symptoms due to the fact that common brain structures are affected. These diseases evolve progressively over several years and their early diagnosis, when the symptoms are discrete, makes them even more difficult to diagnose at this stage. In addition, co-morbidities are common in the elderly, further complicating the diagnosis of these diseases.

At present, the only cerebrospinal fluid (CSF) biomarkers that are routinely used for the biological diagnosis of neurodegenerative cognitive pathologies are those specific to Alzheimer's disease: Aβ42, Aβ40, Tau-total and Phospho-Tau. These biomarkers represent an almost indispensable tool in the diagnosis of dementia.

It is therefore important to determine whether Alzheimer's biomarkers can be disrupted in other neurodegenerative cognitive pathologies, but also to find biomarkers specific to these different pathologies by facilitating the implementation of clinical studies which will thus make it possible to improve their diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar puncture (LP)
* Patients with accurate clinical diagnosis

Exclusion Criteria:

* Patients who do not have a lumbar puncture
* Patients for whom no accurate diagnostic information is available
Quality of Life and Mental Health in Children and Adolescents

The purpose of this study is to investigate different aspects of Quality of Life and mental health in patients under treatment in a child and adolescent psychiatric outpatient clinic and in the normal population.

Measuring and monitoring Quality of Life in children and youths continues to increase in importance to both researchers and decision makers. Only a limited number of well validated instruments that measure Quality of Life in children exists, and in Norway only few has been translated into Norwegian. Up to date there are no studies investigating the quality of Life in Norwegian child and adolescent psychiatric patients in a longitudinal perspective, compared to the normal population.

Two generic Quality of Life instruments (KINDL, Bullinger \& Ravens-Sieberer 2000 and the ILC, Matejatt \& Remschmidt 1998) are introduced in Norway by this study in addition to the use of other well established measures like the "Child behaviour Check List" (Achenbach et al. 2001), etc.

Comparisons: 400 patients and their parents in a child psychiatric outpatient clinic 2000 pupils from the normal population in the middle of Norway Repeated measures after 6 months in both groups. In addition a follow up study for the clinical group 3 years after referral started in june 2006.

Eligibility Criteria:
Inclusion Criteria:

* All children 9-16 years of age, attending the 4th, 6th, 8th or 10th grades at public or private schools with at least 50 pupils, in the period from the 1st of September 2004 until 15th of July 2005 in the county of Sør-Trøndelag. Subjects and parents have to give their informed consent.
* All patients 8-10 years of age consecutively referred to to the child psychiatric outpatient clinic in the period from the 1st of June 2003 until 31st of December 2005, having a minimum of two direct contacts with the clinical staff. Patients and parents have to give their informed consent.
* Follow up: Three years after the patients met at the outpatient clinic for the first time.

Exclusion Criteria:

* Pupils lacking sufficient competence in the Norwegian language, due to foreign background or having a mental developmental level of more than two grades under the respective grade.
* Patients with psychosis or serious mental retardation.
Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.

Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with diabetes type 1
* Pregnancy initiated between 2009 and 2015
* Pregnancy followed up in the universitary hospital center of Montpellier

Exclusion Criteria:

* Women who deliver in an other center
* women with intraperitoneal injections of insulin
* twin gestation
* termination of pregnancy
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents

This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.

This study is designed to compare self-directed bibliotherapy and therapist-directed cognitive behavioral therapy for children and adolescents with Obsessive Compulsive Disorder (OCD). Both treatments involve exposure and response prevention (EX/RP), in which the child confronts OCD fears and is asked to refrain from compulsive rituals (such as repetitive handwashing, counting, etc.). Participants are requested to complete an initial evaluation to determine diagnosis, and four follow-up evaluations to assess symptom severity and change due to treatment for a total of 16 weeks. Participant involvement to self-directed bibliotherapy versus traditional cognitive-behavioral treatment will be determined through random assignment.

In the bibliotherapy condition, the child or adolescent will meet with a therapist twice over the course of treatment, along with a parent. The therapist will discuss a self-directed program of EX/RP to be implemented at a pace deemed appropriate by child and parent at their own home. The child and parent will be provided with a manual designed to instruct them how to cope with Obsessive Compulsive Disorder. This treatment involves the parent and child reading the book, performing exercises, and monitoring symptoms on a weekly basis for 8 weeks.

In the therapist-directed treatment condition, the child or adolescent will meet weekly with a therapist along with their parent. The therapist, parent, and child will work together to design and implement a program of EX/RP. This treatment involves performing exercises, monitoring symptoms on a weekly basis, and completing homework assignments. Parents will be asked to help coach their child with at-home exercises challenging the Obsessive Compulsive Disorder. This treatment lasts 12 weeks.

Evaluations will be conducted following the completion of each treatment to assess the efficacy of each treatment on OCD symptoms. The treatment and evaluations for OCD are provided free of charge.

Eligibility Criteria:
Inclusion Criteria:

* Ages 8-18 years old
* Primary diagnosis of Obsessive Compulsive Disorder
* Both parent and child fluent in English
* Parents must read at least a 7th grade reading level

Exclusion Criteria:

* Primary psychiatric diagnosis other than OCD
* Current threat of harm to self or others
* New use or dosage change of OCD medication 60 days prior to starting program
* Current involvement with another psychosocial therapy
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

This is a multicenter, randomised phase II trial in patients with high risk GCT.

Primary objective:

* Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care

Secondary objectives:

* Determine the relapse free survival
* Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

GCT is a potentially malignant tumour that presents with a locally destructive osteolytic lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%. Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk' GCT in order to improve clinical outcomes and reduce the recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female \> 18 years of age
* Histologically proven GCT treated with surgery
* High risk GCT defined as minimal one or more of the following:

  * Recurrent GCT
  * GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue
  * GCT grade III
  * Pathological fracture in GCT
  * Absence of local adjuvant therapy (cryosurgery or phenol instillation)
* Neutrophils \> 1.5x109/L, platelets \> 100x109/L, and Hb \> 6 mmol/l
* Bilirubin level \< 1.5 x ULN
* ASAT and ALAT \< 2.5 x ULN
* Adequate renal function as defined by: serum creatinine clearance \> 60 cc/min
* Expected adequacy of follow-up

Exclusion Criteria:

* Unresectable or metastatic GCT and grade IV GCT
* Prior bisphosphonate usage, except preoperative treatment with zoledronic acid up to 3 months before surgery
* Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Known hypersensitivity reaction to any of the components of the treatment
* Pregnancy or lactating
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D

We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged between 50 and 65 years
* Between 1 and 5 years menopause
* IMC between 19 and 30 kg/m²

Exclusion Criteria:

* Medical Treatment for bone metabolism
* Vitamin D not including in the range of 20nmoles\<25(OH)\<100nmoles/l
* Vegan and vegetarian diet
* Regular consumption of food supplementary benefits
* Lactose intolerance
* While dieting
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.

Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. In this Norwegian national multicenter observational study, patients with complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a Watch\&Wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
* Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
* Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W\&W approach after careful consideration and well-documented informed consent are eligible for entering the W\&W protocol.
* Given informed consent
* Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included

Exclusion Criteria:

* Patients without cCR
* Patients unable to give informed consent
* Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
* Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
* Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
* Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy
* Other circumstances that may interfere with successful participation in the W\&W protocol
Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.

Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.

Control group (A):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
3. BMI will been measured body weight(Kg) and height (m2)

   a. BMI= body weight (Kg)/ height (m2).
4. Waist circumference will be measured.
5. After one month blood analysis evaluation will be done to record the response to the routine medication.

Training Procedure for group (B):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
3. BMI will been measured body weight(Kg) and height (m2)

   a. BMI= body weight (Kg)/ height (m2).
4. Waist circumference will be measured.
5. The maximum heart rate will be determined from Tanaka formula (208- 0.7 \*age of the participant)

   * Then the exercise load will be determined according heart rate reserve of the participants ( maximum heart rate - resting heart rate).
6. Start with sitting resting without any effort for 5 min then Start at a low speed and intensity for 5 minutes to warm up the body.
7. Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.
8. Finally, a five minutes of cooling down with no resistance had performed.
9. After one month blood analysis evaluation will be done to record the response to the routine medication.

Eligibility Criteria:
Inclusion Criteria:

* female aged 45-60 years old.
* class 1 and 2 obesity.
* post menopausal.
* diagnosed as controlled diabetic.
* diagnosed as controlled hypertensive.

Exclusion Criteria:

* uncontrolled diabetic.
* uncontrolled hypertensive.
* class 3 and morbid obesity.
* mentally unstable person.
* Any shoulder, hand and elbow orthopedic or neural disorders.
DE-117 Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT


Eligibility Criteria:
Inclusion Criteria:

* Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
* Provide signed written informed consent.
* Diagnosis of POAG or OHT in both eyes.
* Qualifying corrected visual acuity in each eye.
* Qualifying central corneal thickness in each eye.
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
* Qualifying Anterior chamber angle.
* Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Exclusion Criteria:

* Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
* Patients with prior exposure to DE-117.
* History of ocular surgery specifically intended to lower IOP
* Advanced glaucoma in either eye.
* Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
* Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
* Females who are pregnant, nursing, or planning a pregnancy.
LEICeSter Tendon Extracorporeal Shockwave Studies

To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured home-exercise programme has any additional benefit to patients with tendinopathies

This involves patients with one of 6 different defined chronic tendinopathies. These individual sites are run as discrete sub-studies, with randomisation n occurring within sub-study grouping

Eligibility Criteria:
Inclusion Criteria:

1. Patients age \>18
2. Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:

   1. Plantar fasciitis
   2. Insertional Achilles tendinopathy
   3. Mid-substance Achilles tendinopathy
   4. Patella tendinopathy
   5. Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis)
   6. Tennis elbow
3. Referred for ESWT (shockwave) within the Sports Medicine Department
4. Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)

Exclusion Criteria:

1. Patients with the normal exclusions for ESWT - including pre-existing skin injury over tendon site, recent steroid injection (within 6 weeks of ESWT starting), patients on anticoagulation, patients with haemophilia or other bleeding tendency, patients with current febrile illness
2. Previous ESWT treatment for the same condition
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

The investigators evaluate the changes of echocardiographic and sleep apnea parameters after mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep apnea control and the results are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* mitral valve defect
* NYHA II-IV
* no additional cardiac surgical procedure

Exclusion Criteria:

* Pregnancy
* lung disease
* regular follow-up in the study Center in the first 6 months after surgery not guaranteed
* congenital heart disease