cyrilzakka/clinical-trials huggingface dataset:
Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders

The aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low responder patients.

During controlled ovarian hyperstimulation (COH), most of the early antral follicles are required to grow coordinately. Marked follicular size discrepancies during COH imply that an important number of follicles undergo unsatisfactory maturation. It has been proved that follicular priming with estradiol during the luteal phase of the cycle prior to COH or testosterone treatment during the early follicular phase of the COH cycle may increase the amount of oocytes and embryos retrieved. Nevertheless there are no prospective studies comparing such approaches. The present study consist of two phases:

The present study consists of two different phases:

* Phase I: (Non randomized) Identification of confirmed low responder patients. Potential low responder patients will be subjected to an standardized ovarian hyperstimulation protocol
* Phase II: (Randomized) those patients, once confirmed as low responders, will be offered the opportunity to enter the interventional part of the study, being randomized to three different treatment groups: estradiol, testosterone or combined progestagens and estrogens prior to the IVF-ICSI cycle. The previous cycle (phase I) will be used as a self-control for each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Phase 1 (Non randomized. The patient must fit the first plus at least other 2 criteria)

   * Infertility requiring an IVF/ICSI treatment
   * Age ≥ 38 years
   * Basal FSH ≥ 10 mUI/ml (day 3 of the cycle)
   * Serum AMH ≤ 5 pmol/l
   * Antral follicular count ≤ 6 (day 3 of the cycle)
2. Phase 2 (Randomized. The patient must fit at least one criterion regarding the day of GNRH analogue administration during the cycle performed in Phase 1)

   * Less than 4 follicles which mean diameter measuring more than 16mm
   * Serum estradiol levels ≤ 500 pg/ml
   * 4 MII or less than 4 MII oocytes retrieved

Exclusion Criteria:

* Patients suffering of endometriosis
* Patients having progesterone levels ≤ 4 ng/ml (day 21 of the cycle)
* Patients having a partner affected by severe oligo/astheno/teratozoospermia
European Transfusion Practice and Outcome Study

The aim of the ETPOS study is to describe differences in transfusion habits throughout Europe and to correlate these habits to perioperative outcome parameters. Special focus is put on the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to other blood products or coagulation factors in the operating room. Furthermore the motivation of physicians to transfuse PRBC and blood products in the operating room will be investigated.

In European patients undergoing elective non-cardiac surgery receiving at least one PRBC(packed red blood cells) during their surgery it is proposed to:

1. Evaluate evidence of differences in the standard of peri-operative transfusion care in different healthcare systems within Europe, and the use of blood conserving techniques.

   1. Evaluate the ratio of transfusion of PRBC to blood products in the operating room
   2. Evaluate which factors determine transfusion of PRBC (is it patient's haemodynamics / haemoglobin threshold/ pressure from the surgeon / acute brisk bleeding / else) and blood products (ratio to PRBC / POC (point of care) monitoring/ per protocol/ else) in the operating room
2. Evaluate whether there are factors in transfusion therapy that are associated with outcome (in-hospital mortality and unplanned admission to ICU(Intensive Care Unit).)

Eligibility Criteria:
Inclusion Criteria:

- patients undergoing elective non-cardiac surgery commencing during the three-month period and who received at least one erythrocyte concentrate during their intra-operative stay.

Exclusion Criteria:

* Age \< 18 years
* cardiothoracic surgery
* emergency trauma patients
Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients

General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized patients.

Investigators hypothesized that the SpO2 breathing air can personalize the open-lung approach.

Increase in airway pressure until the SpO2 reaches 97% (lung´s opening pressure) during the incremental positive end-expiratory (PEEP) limb. Decrease in the PEEP level until the SpO2 decreases bellow 97% (lung´s closing pressure)

Eligibility Criteria:
Inclusion Criteria:

* Non-obese patients with ASA physical status I-III undergoing elective abdominal laparoscopic surgery with an expected operating time of less than 2 hours were included.

Exclusion Criteria:

* age of \<18 years,
* preoperative SpO2 ≤97% while breathing room air, and
* patients with previous known cardiac or respiratory disease.
Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery

During physical activities, the time available to produce a force is infinitely shorter than the time required to reach maximal muscle capacity.

Previous studies have observed that the time elapsed between ground contact and ACL rupture is on average 50-60 ms, suggesting that this is the time window available for any attempt at dynamic stabilization of the joint through muscle contraction.

Sports movements include ballistic movements, defined as very fast movements whose objective is to accelerate a moving mass as much as possible so that it reaches a high speed in a very short time. This is the case for vertical jumps, running and most movements performed in physical and sporting activities.

Thus; (1) isokinetic tests do not allow a rigorous analysis of the components related to the speed of the movement; (2) functional tests such as jumping, which only give a distance between one leg and the other, do not allow the calculation of precise and reproducible variables concerning the force and speed of the movement, in particular during the first milliseconds of the movement, and do not provide information on compensation phenomena. It is therefore interesting to use the ballistic tests developed to monitor the movements of athletes as a new possible indicator of the return to sport.

The main objective of this study is to evaluate the performance of ballistic tests in predicting failure to return to physical activity 24 months after ACL surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years),
* Patient who has undergone ACL reconstruction of the hamstrings with or without associated extra-articular plastic surgery:

  * Isolated ACL sprain without injury to the collateral ligaments or the PCL,
  * ACL reconstruction without associated meniscal injury or with repaired or menisctomized meniscal injury,
* Having to perform a K-STARTS test and an isokinetic test,
* Having the Tegner score before the rupture.

Exclusion Criteria:

* Patient with high cardio-respiratory risk,
* Osteoarticular and neuromuscular traumatic sequelae of the lower limbs,
* Degenerative neuromuscular diseases,
* Connective Tissue and Collagen Disease (e.g. Marfan),
* Follow-up of a medical treatment that may influence the neuro-muscular system (e.g., antidepressants, etc.) during the tests,
* Pregnant, parturient or breastfeeding patient.
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.


Eligibility Criteria:
Inclusion Criteria

1. Male or female at least 20 years of age with life expectancy ≥ 3 months
2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay
3. Evaluable disease according to RECIST, Version 1.1
4. Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy
5. ECOG performance status of 0 or 1
6. Demonstrate adequate bone marrow, liver, and renal functions, defined as:

   • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10\^9/L, platelet count ≥100 × 10\^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL.
7. Voluntary written informed consent form before performance of any study-specific procedures or tests

Exclusion Criteria

1. Prior therapy with an EGFR inhibitor and/or tivantinib
2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization
3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization
4. Major surgical procedure within 4 weeks prior to randomization
5. History of cardiac disease
6. Known symptomatic brain metastases
7. Need to breastfeed a child during or within 12 weeks of completing the study
8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib
9. History of malignancy other than NSCLC
10. Known infection with HIV, active HBV or HCV
11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases
12. Psychiatric disease that could affect the informed consent process
13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective
14. Positive serum or urine pregnancy test in female subjects of childbearing potential
15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation
A Randomised Feasibility Trial With Internet Based Self-help Therapy

Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care services plan to implement internet based self-help psychotherapy (IBT) to be an important alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the effect of IBT for anxiety disorders seems better than no intervention, and in some instances equal to 'usual therapy'. But studies have been characterised by small sample sizes, high risk for bias, including high dropout.

Objective. The objective of this pilot trial is to assess the feasibility of conducting a larger confirmatory trial investigating the benefits and harms of an internet-based self-help therapy program, FearFighter™, compared with no intervention for persons with an anxiety disorder.

Design. An investigator-initiated feasibility randomised clinical trial investigating internet-based therapy with FearFighter™ compared with no intervention for persons with an anxiety disorder. We will include 64 participants.

Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder, agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or psychosis; concurrent psychological treatment for the anxiety disorder; unable to attend the intervention; or lack of informed consent.

Intervention. The intervention group will use the program FearFighter™, a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. The control group receive no intervention for nine weeks.

Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are randomised, and the compliance in the intervention group. Clinical exploratory outcomes are: remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan Disability Scale, serious adverse events, and behaviour log from FearFighter.

Time schedule. Participants will be included in the trial from July 2015. Results are expected in February 2016.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
* Written informed consent.

Exclusion Criteria:

* Acute suicidal risk.
* Ongoing episode of bipolar disorder or psychosis.
* Receive concurrent psychological treatment for an anxiety disorder
* Considered unable to attend IBT sessions as planned (due to vacation, work/study placement, sickness or similar occurrences).
* Lack of informed consent.
Efficacy of First Time Anterior Shoulder Decision Tool

This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention.

Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation

An anterior shoulder dislocation is a common problem for people between the ages of 15 to 35. Recurrent instability is common and dependent on age and gender. Treatment options include surgical intervention and repair or non-surgical options that include intensive rehabilitation. Level I evidence suggests early surgical repair can significantly reduce the risk of recurrent instability. The risk of arthritis is increased with multiple dislocation episodes.

Traditionally, the combination of 1) history and physical exam performed by the provider, 2) clinical and diagnostic tools to assess the extent of injury and impact on physical activity, and 3) patient-voiced preference has guided the selection of an optimal solution for an individual patient. When providing a recommendation to individual patients and their unique circumstances, the health care provider may gather patient preferences on factors such as desire to avoid pain, chance of recurrent shoulder dislocation, time needed for rehabilitation and physical therapy, and operative versus non-operative costs. Surgical and non-surgical options have distinct differences in these outcomes. When combined, the interaction between these variables creates important tradeoffs of risks and benefits for each option.

No studies have been conducted to determine the objective weight of these different dimensions of patient preferences and how they might guide the provider-patient conversation. Conjoint analysis is a statistical method that seeks to quantify the relative importance of various aspects of the decision-making process, such as cost or probability of repeat injury as described above. Combined with a validated survey tool, conjoint analysis of patient preferences in shoulder repair can assist the physician in recommending a patient-centered option.

Eligibility Criteria:
Inclusion Criteria:

- Shoulder dislocation

Exclusion Criteria:

* Prior surgery for shoulder stabilization
* Inability to complete enrollment forms
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

Objective:

To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.

Background:

Diabetic nephropathy is a world wide public health concern of increasing proportions. It has become the most common single cause of end-stage renal disease in the United States and in Europe. Previous studies have already found agents modifying the renin-angiotensin-system (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These agents are likely to exert multiple effects in the kidney. One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics.

In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. In that study, rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a reduction of urinary albumin excretion. The observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).

Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

type 2 diabetes mellitus -age between 40 and 75 years -well controlled HbA1c (\< 7.5%) -chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation) -proteinuria \> 300 mg / 24 hours

Exclusion Criteria:

type 1 diabetes -poorly controlled type 2 diabetes (HbA1c \> 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value -CHF (more than grade 1 of NYHA) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women
Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) \[min\]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 50 years
* Fulfilled the Chuang criteria
* And currently:

  * PMR-AS\> 10
  * Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
* Able to give informed consent
* Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.

Exclusion Criteria:

* Clinical symptoms of giant cell arteritis
* Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
* History of major organ or haematopoietic stem cell/marrow transplant
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
* Planned surgical procedure within 12 months after randomization.
* History of malignant neoplasm within the last 5 years.
* Current active infection
* Patient with elevated ALT or AST\> 5 ULN
Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial

This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function.

All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.


Eligibility Criteria:
Inclusion Criteria:

- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.

Exclusion Criteria:

* Failure to attend the pre-surgery assessment session;
* Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
* Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.

Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.

Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.

Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).

EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient required mechanical ventilation more than 14 days
* No ability for active endurance exercise because of poor consciousness or limb weakness.

Exclusion Criteria:

* Pregnant women
* Limb wound/infection interfered with electric pad application
* Recent acute myocardial infarction or life-threatening arrhythmia
* Uncontrolled epilepsy
* Dying patients without attempt of ventilator weaning
* Absence of respiratory drive