cyrilzakka/clinical-trials huggingface dataset:
A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer

The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy.

onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.

Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.


Eligibility Criteria:
Inclusion Criteria:

* Indication for Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

* according to the Paclitaxel SmPC
TSH And AMH in Infertile Women

Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary.

Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy as well as fertility, regardless of the presence of disease in women of reproductive age. In particular, hypothyroid women are at an increased risk of menstrual disorders and infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release of gonadotropin-releasing hormone.

The prevalence of subclinical hypothyroidism characterized by aberrant high serum thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile women are reported to be approximately 20% and it is a primary cause of subfertility.

Indeed, average TSH levels in infertile women were reportedly higher than those in normal fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve fertility to successful pregnancy.

This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et al., 2013).

On the other hand, female fecundity decreases with increasing age, primarily because of decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and differentiation. It is produced by the granulosa cells from pre-antral and small antral follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of ovarian age in women of reproductive age.

Expectedly, ovarian function may be affected by impaired thyroid function, although this association has not been elucidated. In this study, we will evaluate the relationship between thyroid function and AMH levels by comparing them in infertile patients and healthy fertile women.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-35 years
2. Diagnosed as primary infertility.
3. Duration of marriage more than 1 year.
4. Controls should be normal fertile women aged 20- 35 years had no history of treatment for infertility or thyroid disorders.

Exclusion Criteria:

1. Age: above 35 years old.
2. Women with ovarian dysfunction (PCO, post ovarian surgery).
3. Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism).
Efficacy Study of Rectus Sheath Block to Control Postoperative Pain

The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* 3-15 years of age children
* Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

Exclusion Criteria:

* ASA physical status III and above
* Parents who did not consider to participate in the study
* Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure
The Representation of the Sensibility of the Breast on the Somatosensory Cortex

Rationale: The representation of the breast on the somatosensory cortex has not been precisely located. Therefore, a pilot study with healthy subjects is needed to localize the sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.

Objective: To determine the exact localization of the representation of the sensibility of the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether there are differences in representation between individuals of the same sex and between both sexes.

Study design: A single center pilot study carried out in the Maastricht University Medical Center, the Netherlands.

Study population: A total of 10 female and 10 male healthy individuals will be recruited.

Intervention: Every subject will undergo a functional MRI scan with stimulators applied to the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast and nipple-areola complex in a random sequence.

Main study parameters: The hemodynamic response after stimulation of the skin of the breast and nipple-areola complex, representing neuronal activity in that region, is measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the various stimulation conditions are assessed, and the representation of the breast on the somatosensory cortex is mapped.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Between 21 and 35 years old
* Healthy; i.e. no comorbidities
* Women: breast size cup B or C
* BMI \< 27.0 kg/m2
* Informed consent

Exclusion Criteria:

* Any comorbidities
* Previous breast operation of any kind
* Previous allergic reactions to adhesives or plasters
* Any MRI exclusion criteria e.g.:

(No piercings or other iron materials (except a metal brace behind front teeth) (Claustrophobia)
The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings

This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to reperfusion in patients presenting with STEMI. A randomised controlled trial will be conducted in Gauteng and the Western Cape among 100 adult patients (\>18 years) presenting with ST-elevation myocardial infarction according to a specific inclusion and exclusion criteria outlined in the full protocol. Consenting patients will be randomly assigned to have their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the two groups by using the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected to multivariate analysis of variance to test for statistical significance within a variety of factors that may influence reperfusion times.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years of age)
* Patients presenting within the Gauteng or Western Cape areas
* Current chest pain or dyspnoea, presumed to be of cardiac origin
* ST-elevation (STEMI) on the ECG (defined as ST-elevation of 0.1 mV in two or more contiguous leads).

Exclusion Criteria:

* Non-adult patients
* Chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology)
* Non-consent to inclusion within the study
* Patients without medical aid or who states that they cannot afford private healthcare.
* Non-ST-elevation myocardial infarction
Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer

To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer


Eligibility Criteria:
Main Inclusion Criteria:

1. subjects with a histopathological or cytologically diagnosis of BTC
2. The participants must be required to sign an informed consent
3. At least one measurable lesion (RECIST 1.1)
4. No previous systematic treatment for BTC
5. Child-Pugh Score, Class A
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Life expectancy of at least 3 months

Exclusion Criteria:

1. Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
2. Known history of serious allergy to any monoclonal antibody
3. Known central nervous system metastases and/or leptomeningeal disease prior to treatment
4. Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
5. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
6. Any active malignancy prior to the start of treatment
7. Active or history of autoimmune disease
8. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
9. Pregnant or lactating women
Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries

The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

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Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block

Exclusion Criteria:

* Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system
Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery

It has been suggested that obese people are more sensitive to sensory and rewarding effects of food, aspects that mediate food preferences and intake. Individuals that underwent Roux-en-Y gastric bypass surgery frequently report changes in food preference. They indicate a decreased preference for highly rewarding energy dense foods. Changes in food preference might be related to alterations in central (brain) mechanisms, related to reward sensing. The smell and sight of food can be considered as anticipatory cues for the rewarding effects of food intake. The aim of this study is to determine the effect of gastric bypass surgery on (alterations in) food preferences. Secondly, this study aims at assessing the effect of gastric bypass surgery on the brain reward response when exposed to sight and smell of food stimuli with different sugar and fat contents.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Roux-en-Y Gastric Bypass Surgery at Rijnstate hospital

Exclusion Criteria:

* Lack of appetite
* Having difficulties swallowing/eating
* Being a vegetarian
* Allergic to food product used as stimuli in the study
Effects of Bisphosphonates on OI-Related Hearing Loss

Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in their 20s. Bisphosphonates have been successfully used to treat otosclerosis, a common cause of hearing loss similar to OI-related hearing loss. As many individuals with OI-related hearing loss also present with otosclerosis and because of their mechanistic similarities, the investigators propose studying the effects of bisphosphonate treatment on individuals diagnosed with both OI type I and hearing loss, thereby determining its effectiveness as a potential treatment for hearing loss.

The investigators will enroll 50 individuals diagnosed with type I OI and age 18-100. 25 adults will be enrolled into the treatment arm and receive bisphosphonate treatment (must have at least mild hearing loss), while 25 adults will be enrolled into the control arm. The investigators will enroll 25 children (6-17 years of age) diagnosed with OI who are currently receiving bisphosphonate treatment as part of their care for orthopedic symptoms. The investigators will also observe 25 children (6-17 years of age) diagnosed with OI who are NOT currently receiving bisphosphonate treatment. The study duration is 63 months (approximately 5 years). Enrollment is anticipated to begin in November 2019.


Eligibility Criteria:
Inclusion Criteria (Adult Treatment Arm):

* Diagnosis of OI type I
* Diagnosis of at least mild hearing loss (\>20dB pure tone average) by audiogram testing
* 18+
* Vitamin D level \> 30

Inclusion Criteria (Adult Control Arm):

* Diagnosis of OI type I

Inclusion Criteria (Child Observational Bisphosphonate Arm)

* Diagnosis of OI
* Age 6-17 years
* Currently receiving bisphosphonate treatment as standard of care

Inclusion Criteria (Child Observational No Treatment Arm)

* Diagnosis of OI
* Age 6-17 years
* NOT receiving bisphosphonate treatment and will not receive bisphosphonate treatment for the duration of the study

Exclusion Criteria (ALL ARMS):

* Family history of hearing-loss (not related to OI or occupational hearing loss)
* Pregnancy
Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Male or female (non-pregnant)
* Clinically diagnosed trigger digit
* Subject is able to provide voluntary, written informed consent
* Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Exclusion Criteria:

* Age \<18 or \>90
* Pregnant or lactating women
* Non-English speaking individuals
* Medication contradictions to lidocaine, corticosteroids and/or saline
* Prior injection or surgery on the affected finger
* Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
* Open wound
Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.

The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
* Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
* 16 Years and older

Exclusion Criteria:

* Less than 16 Years of age
The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Cardiac Surgical Patients

The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in cardiac surgical patients


Eligibility Criteria:
Inclusion Criteria:

1. adult ( ≧19 years old)
2. patients undergoing elective cardiac surgery

Exclusion Criteria:

1. emergency surgery
2. patients under cervical immobilization
3. anatomical abnormality
4. infection or hematoma at puncture site
5. patients who did not need internal jugular vein catheterization
Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients

The goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of advanced prostate cancer, i.e., metastatic castration-resistant prostate cancer (mCRPC). It will also learn about the safety of this combination.

Researchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male patients 18 years or older
* Diagnosed with metastatic prostate cancer
* History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration
* Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
* Clinical decision to start doc infusion with prednisone treatment
* Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³)
* Adequate liver function (total bilirubin less than upper limit of normal (ULN), alanine aminotransferase (ALT) less than 1.5 x ULN, aspartate aminotransferase (AST) less than 1.5 x ULN)
* Adequate renal function (serum creatinine level within normal limits)
* At least a 6-month or greater life expectancy
* Willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention

Exclusion Criteria:

* Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
* Any comorbid condition that would preclude the administration of docetaxel/prednisone
* Ongoing alcohol abuse
* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* Prior allergic reaction to tea, tea products or quercetin supplements
* Allergies to multiple food items or nutritional supplements
When and Why Desarda Repair

One of the most significant subjects studied in abdominal wall surgery is inguinal hernia. Its management is very codified.

The main factors evaluating efficient hernia surgery are not only the rate of complications (recurrence and groin pain essentially) but also cost and time to return to normal activities.

Desarda technique is a non-mesh technique described first in 2001. This surgical technique uses a flap of external oblique aponeurosis in place of a mesh. Its singularity remains its low cost, no use of mesh, and less extensive dissection

Mesh repair has its own limitations; it is unphysiological as mesh is used. Chronic inguinal pain, seroma formation, foreign body sensation, risk of mesh infection are common complications and not recommended in strangulated hernias and extra cost involved by the mesh itself.

It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia. Recurrence and complication rates equal to or less than Lichtenstein's repair. It's a simple procedure, early ambulation and less time of hospital stay, low cost for the patient as mesh is not used and most importantly no question of mesh related complications such as mesh rejection, infection, migration and foreign body sensation and chronic groin pain which is comparatively low in this procedure.


Eligibility Criteria:
Inclusion Criteria:

* primary inguinal hernia
* Aged 18 and above
* reducible inguinal or inguino-scrotal hernia

Exclusion Criteria:

* Obstructive uropathy or chronic obstructive pulmonary disease
* incarcerated hernia
* recurrent hernia
* bilateral hernia
* active infection at groin area
* pantalloon hernia