cyrilzakka/clinical-trials huggingface dataset:
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between August 2016 and August 2019
* Informed consent

Exclusion Criteria:

* Total flap loss complication
* Flaps that required a take-back
* Follow-up less than six months postoperatively
* Only one postoperative measurement at less than 12 months follow-up
* Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side
Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees

Background:

Trauma is the second most common factor for transtibial amputations, just after vascular background. Traumatic amputees generally function better than amputees due to vascular background. The type of prosthetic foot fitted to the patient depends on his mobility and functional level, and significantly influences his stability and gait symmetry. A prosthetic foot with a hydraulic ankle provides significant advantages for high level functioning amputees: decrease of loads in the residuum, improvement in symmetry and generally gait pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded to include computerized control over the ankle movement, using input from an array of sensors inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern that is more similar to healthy people. However, hydraulic feet with and without computer control have not been compared. Furthermore, the effects of a computerized foot on various important factors have not been investigated yet, e.g. loads in the residuum, the movement of the center of pressure and the patient's satisfaction.

Research objectives:

To compare between hydraulic prosthetic feet, with and without computerized control. The comparison will be made while walking on flat or inclined surfaces (positive or negative inclination). Differences in gait parameters, loads inside the residuum, center of mass movement and patient's satisfaction will be quantified.

Research hypothesis: Using a computerized prosthetic foot will provide better mobility performances: improved gait factors and center of pressure movement, decrease internal loads in the residuum and increase patient's satisfaction.

Research design:

Clinical controlled research with research group(amputees) and control group (healthy).

The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20 to 70 years old
* Traumatic unilateral Transtibial Amputee
* Using Echelon foot prosthesis for at least 6 months
* K level 3 or 4

Exclusion Criteria:

* Injury of the sound limb that compromises the gait of the amputee.
Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.

Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

All patients had a recurrent nasal pterygium after one surgical session for removal of the primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium who had more than one session for surgical removal were excluded. As well, patients with cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the study.

A comprehensive ophthalmic examination, including best-corrected visual acuity testing, slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of ocular motility, was carried out for all patients. According to their corneal extent, pterygia were classified into 3 grades:

Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.

Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3: Fibrovascular proliferations extend beyond the visual axis.

Consents were taken from all patients and research was approved by the institutional review board. All measures were in accordance with the tenets of the Declaration of Helsinki.

As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to 86°F).

As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient

Eligibility Criteria:
Inclusion Criteria:

recurrent nasal pterygium after one surgical session for removal of the primary one

Exclusion Criteria:

* primary nasal pterygium,
* recurrent pterygium with more than one session for surgical removal
Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia

Minimal invasive intra-arterial prostaglandin therapy is currently being offered as an established and safe treatment approach for Non-occlusive mesenteric ischemia (NOMI). So far, there are no data that prospective evaluate clinical response parameters of this method and corresponding criteria for response.

The investigators are therefore planning a prospective observational study on NOMI patients with the aim to collect

1. routine clinical data,
2. data from advanced angigraphic imaging and
3. data from blood biomarkers of intestinal ischemia before/at implementation of intra-arterial vasodilatory therapy.

From these three data packages, the investigators hope to subsequentially derive criteria to better predict response to therapy.


Eligibility Criteria:
Inclusion Criteria:

- persistent shock: Norepinephrine dose \> 0.2ug/kg/min over \> 48hrs

and

* intestinal failure: paralytic ileus \> 24hrs despite neostigmine therapy or
* new onset progressive organ failure (2 out of six criteria): Norepinephrine dose increase, rise in serum lactate, decrease in Horowitz index, new renal replacement therapy, rise in bilirubin, rise in INR, or all of the following: rise in ALT, AST, CK and LDH

Exclusion Criteria:

* patients \< 18 years old
* pregnancy
Early Diagnosis of Gastric Cancer Cachexia

Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In gastric cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with gastric cancer diagnosed by histopathology or cytopathology
2. Complete clinical and pathological data
3. No previous or current mental illness or disturbance of consciousness

Exclusion Criteria:

1. With multiple tumors or other malignant diseases
2. Combined with other chronic wasting and metabolic diseases
3. Past patients with non-tumor cachexia
4. People with mental illness or unable to cooperate
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely used reconstruction method. It is controversial if surgical denervation by transecting the thoracodorsal nerve should be performed or not. It is assumed that after denervation the latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand discomforting signs and symptoms from muscle contraction are believed to be prevented if flap is denervated. The aim of the study was prospectively evaluate the influence of LD-flap innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to compare the change in muscle structure in breast MRI and histopathology.


Eligibility Criteria:
Inclusion Criteria:

* delayed LD-flap breast reconstruction, no recurrent disease observed

Exclusion Criteria:

* recurrent cancer, partial resection of the breast
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate).

Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy between 24 and 31.6 weeks
* singleton fetus
* threatened preterm birth.

Exclusion Criteria:

* Fetuses: congenital anomalies
* Mothers: severe or multiple maternal illnesses
* Drug users or institutionalized or psychotic women
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ACTH independent endogenous Cushing's Syndrome
* Available adrenal imaging prior to being treated with Korlym®
* Treated with Korlym® and followed for at least 3 months (follow-up data should be available)

Exclusion Criteria:

* Diagnosed with adrenocortical carcinoma
* Participant in any clinical trial(s) during the observational period
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects

This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects
2. Aged 18 to 55 years, inclusive
3. Subjects who were healthy as determined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead resting electrocardiogram (ECG; corrected QT interval \[QTc\] ≤450, QRS \<120, PR \<220; normal morphology) performed at the screening visit and prior to each dosing
4. Body mass index (BMI) of 18.0 to 35.0 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator and body weight \>50 kg
5. Subjects who were willing and able to be confined at the clinical research centre for the scheduled inpatient visits
6. Ability to swallow multiple tablets whole

Exclusion Criteria:

1. Subject had a clinically significant history of GI, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders and/or drug hypersensitivity
2. Subject had a known or suspected malignancy with the exception of basal cell carcinoma
3. Subject had a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at the screening visit
4. Female subjects who were pregnant or lactating (all female subjects required a negative serum pregnancy test at the screening and a negative urine pregnancy test at each admission).
5. Subject had active disease or symptoms within 7 days prior to Day -1, such as nausea, vomiting, diarrhoea, and infection
6. Subject had undergone a hospital admission or major surgery within 30 days prior to the Screening visit
7. Subjects who had taken part in Part 1 were not permitted to take part in Part 2
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
* Age range: 18-70 years old;
* PSQI score\>7 points; SAS score \> 50 or SDS score \> 53;
* No communication and cognitive impairment;
* No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
* Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
* Sign an informed consent form prior to the start of the study.

Exclusion Criteria:

* Those who do not meet the inclusion criteria;
* Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
* Those with severe liver and renal insufficiency and bleeding tendencies;
* Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
* People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
* Pregnant or nursing;
* Those with other major diseases and poor control;
* Other persons who are unwilling to sign informed consent.
Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)

The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage. Upon completion of the PK/PD stage, the PK/PD profiles for the GHD children in this study will be compared to the PK/PD profiles for the GHD children treated in the Western study Phase 1b/2a study (Protocol 12VR2) and identify the somavaratan dose to be used in the Phase 3 stage in Japan. The Phase 3 stage will continue dosing for 12 months to obtain safety and efficacy data on 48 subjects.

The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage. The study is a randomized, multi-center, open label study. The primary endpoint is height velocity at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Chronological Age ≥ 3.0 years and ≤ 9.0 years (girls) or ≤ 10.0 years (boys)
* Pre-pubertal status
* Diagnosis of GHD as documented by two or more GH stimulation test results
* Height SD score ≤ -2.0 at screening
* Weight for Stature ≥ 10th percentile
* IGF-I SD score ≤ -1.0 at screening
* Delayed bone age

Exclusion Criteria:

* Prior treatment with any growth promoting agent
* History of, or current, significant disease
* Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome
* Birth weight and/or birth length less than 5th percentile for gestational age
* A diagnosis of Attention Deficit Hyperactivity Disorder
* Daily use of anti-inflammatory doses of glucocorticoid
* Prior history of leukemia, lymphoma, sarcoma or cancer
* Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening
* Significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants
* Significant abnormality in screening laboratory studies
The RETRAIN Trial (Phase 1)

The primary objective is to investigate in stroke patients the impact of geko™ NMES treatment, when used as standard of care for VTE prevention, on brain haemodynamics at different stimulation levels and in three different postural positions (supine, semi-supine \[45° seated\] and seated). The aim is to identify the optimal stimulation level and postural position for the maximum response (NMES versus no NMES) with regard to relative total haemoglobin concentration (i.e., the sum of relative deoxyhaemoglobin and oxyhaemoglobin concentrations) using fNIRS and EEG.


Eligibility Criteria:
Inclusion Criteria:

* Adult over 18
* Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
* No intracerebral haemorrhage as ruled out by computerised tomography (CT) or MRI scan.
* Able to achieve a supine, sitting and semi-sitting position of 45° with the help of another person.
* Receiving geko™ NMES treatment as standard of care for VTE prevention

Exclusion Criteria:

* Inability to gain consent from the patient.
* A transient ischaemic attack (TIA).
* Stroke survivors with ischaemic stroke less than 7 days from onset.
* History of epilepsy.
* Below/above knee amputation.
* History of established peripheral neuropathy.
* Too unwell to participate as judged by physician.
* Use of any other neuromodulation device that may interact with NMES
Interaction Between Nalbuphine and Morphine in PCA

1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine

1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine
3. The analgesic effect and opioid-related side effects will be investigated

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 y/o
2. Female patients of ASA physical status I to III
3. Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor

Exclusion Criteria:

1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
2. Intraoperative fentanyl use \> 3 μg/kg
3. Patients with definite diagnosis of esophageal reflux syndrome
4. Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
5. Surgery \> 4 hours or laparoscopy surgery