cyrilzakka/clinical-trials huggingface dataset:
Endometrial Biopsy in Infertile Patients

When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus (endometrium). The endometrium is constantly changing throughout a woman's menstrual cycle in response to the female hormones estrogen and progesterone. The endometrium must have certain characteristics (be at a specific phase in its cycle) in order for the fertilized egg to successfully attach. Infertility may be caused by an "out of phase" endometrium (i.e., the endometrium doesn't have the right characteristics when the fertilized egg reaches it). The purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting the potential for becoming pregnant and bearing a child.

This study will evaluate the utility of the endometrial biopsy as a tool for the routine evaluation of the luteal phase of women presenting for infertility evaluation. The study will establish whether the mid-luteal or late-luteal phase is the most appropriate time to perform an endometrial biopsy. The study will be conducted through the multi-center Reproductive Medicine Network.

Women with a history of infertility will be age matched to fertile women (controls). Women will be randomized either to the mid-luteal phase (7 to 8 days post-ovulation) endometrial biopsy group or to the late-luteal phase (12 to 13 days post-ovulation) endometrial biopsy group. Endometrial specimens will be evaluated histologically by a "blinded" pathologist.

Eligibility Criteria:
Inclusion Criteria for Fertile Patients (controls)

* No history of involuntary primary or secondary infertility
* Willingness to discontinue hormonal contraceptives for 1 month prior to and through the duration of the study
* At least 1 child delivered within 24 months prior to study entry
* Most recent pregnancy resulting in a live birth (no interim spontaneous abortions)
* Tubal ligation within 24 months of study entry is acceptable if all other criteria are met

Inclusion Criteria for Infertile Patients

* History of primary or secondary infertility for a period of at least 12 months
* No hormonal treatments in the month preceding study entry
* No history of tubal ligation
Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers

High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.

Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.

However, in these studies the intensity needed to reach block threshold is very high. The purpose of the present work is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
* Tolerance to the application of electrotherapy.
* That they have not diagnosed any pathology.
* They do not present a contraindication to puncture and / or the application of electric currents.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years at the time of signing the informed consent document
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
* Able to adhere to the study visit schedule and other protocol requirements
* Previously untreated, symptomatic multiple myeloma
* Have measurable disease by protein electrophoresis analyses
* At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
* Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
* Any condition that confounds the ability to interpret data from the study
* Previous treatment with anti-myeloma therapy
* Pregnant or lactating females
* Any of the following laboratory abnormalities:

  * Absolute neutrophil count (ANC) \< 1,000/microL (1.0 × 10\^9/L )
  * Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) \< 50,000 cells/microL (50 × 10\^9/L)
  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 × upper limit of normal
* Renal failure requiring hemodialysis or peritoneal dialysis
* Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
* Subjects who are unable or unwilling to undergo antithrombotic therapy.
* Peripheral neuropathy of ≥ grade 2 severity.
* Uncontrolled systemic fungal, bacterial, or viral infection
* Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
* Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
* Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
* Ineligible for dexamethasone or dexamethasone is contraindicated.
Hand Strength And Hand-Reaction Parameters Of Post Millennial: An Example Of Students' Group In Central Anatolia

The aim of this research is to find out whether there exists a correlation between such important characteristic of individual's hand performance as grip strength, pinch strength, and the hand reaction. In addition, it will be investigated whether there is a change in normative values of this age group in relation to modern lifestyle. The study includes statistical data analysis and interpretation of the derived outcomes.

Objective: To investigate correlation between grip force, pinch strength and hand reaction in a group of post-millennial in Central Anatolia, and also to provide a comparison to previously available results on millennial.

Methods: Experimental data were collected by healthy subjects, who are university students. The sample comprises females and males, consented to participate in the study. The ages of the subjects will range from 18 to 25 years. Grip strength will measure with hand dynamometer and pinch strength will measure with pinch meter. Hand reaction will test with the Ruler Drop Test.

For each subject, body mass, height and hand preference will be record. The study will be completed in accordance with the norms of the Declaration of Helsinki and was approved by the ethics committee of the University of Atilim (Turkey).

The collected data will be undergone statistical analysis to extract any feasible conclusions. First, the correlation coefficients will be found to determine whether there is a noticable relationship between the independent variables grip strength and pinch strength versus the dependent variable ruler drop test. The calculated sample correlation coefficients have been tested for the significance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* History of any upper extremity pain or injury
Management of Indeterminate Thyroid Nodules Across Different World Regions

Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification\[2\]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.

We aim to evaluate different approaches to indeterminate nodules across different countries in the world.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria:

* Patients with preoperative diagnosis of lymph node metastases
Valproic Acid in Treating Cyanotic Breath Holding Spells

Breath holding spells (BHS) are common non-epileptic paroxysmal behavioral involuntary episodes occurring in up to 5.9% of healthy children. The attacks occur in early childhood (0.5-3 years) but are self-limited by school age (4-5 years old) (90%). Classically, BHS were classified as cyanotic (blue), pallid (pale) and mixed based on the color change of the child during the spell. In general, cyanotic spells have been classically described in a toddler with excessive temper tantrums \[stubborn, easily frustration or annoyed. The mechanisms of BHS are controversial. The most suggested cause of BHS is instability of the autonomic nervous system, inhibition of respiratory effort and cyanosis in cyanotic BHS and bradycardia or a brief asystole and cerebral hypoperfusion in pallid BHS. Iron deficiency anemia (IDA) has been widely regarded as a risk factor for BHS in nearly 50% of children due to reduced brain oxygenation \[4\]. It is generally agreed that the long-term prognosis is considered good \[1\]. There is no definite therapy for BHS. In children with low frequency spells, parental reassurance are just enough; however, high frequency spells may result in anxiety to the parents or fear from sudden death of the child or development of mental subnormality. Treatment of iron has been reported to result in reduction of the frequency of spells or its stoppage. Some reported improvement of BHS with piracetam \[a nootropic drug known to increase brain oxygenation\]. We did not find systematized published reports evaluating the effectiveness of antiepileptic drugs (AEDs) in reduction of spells frequency of cyanotic BHS or their stoppage.


Eligibility Criteria:
Inclusion criteria :

1. Children with high frequency spells (≥ 4/week) of CBHS.
2. Children with parents who were wishing to provide treatment to their children.
3. Failure of alternatives modalities of treatment (e.g. iron supplements, piracetam, non-specific vitamins, etc) (tried for ≥ 3 months) to reduce the frequency of spells or stop them.
4. Follow-up for 6 months after starting treatment with valproic acid.

Exclusion criteria:

1. Primary neurologic disease, history of epilepsy or febrile convulsions, abnormal neurological examination and abnormal EEG.
2. Primary cardiac disease or presence of long QT syndrome in the ECG.
3. Presence of a hematologic (other than IDA) or other medical disease, electrolyte disturbance, hypoglycemia, hypocalcemia, impaired kidney or liver function tests.
4. Those with a doubtful diagnosis.
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation

In patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the Danish National Prescription Registry and pillcount and will be related to plasma levels of dabigatran measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and coagulation assays. The aim of the study is to measure the level of adherence and evaluate the usefulness of different coagulation assays to measure adherence in these patients. Furthermore, the aim is to determine the correlation between the anticoagulant effect of dabigatran using different coagulation assays and plasma levels of dabigatran.

Most studies so far have been performed in vitro with plasma samples spiked with dabigatran. In this study the present knowledge from results of coagulation assays in dabigatran spiked plasma samples will be compared to the results of coagulation assays using blood samples from real-life patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Non-valvular atrial fibrillation
* Indication for dabigatran etexilate

Exclusion Criteria:

* Use of anticoagulant medication within the last month
* Contra-indication to dabigatran etexilate
* Unable or not wishing to give informed consent
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy


Eligibility Criteria:
Inclusion Criteria:

* Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.

Distal margin of the tumor at least 6 cm form the anal verge

Staged as follows prior to neoadjuvant chemoradiation:

Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery

Exclusion Criteria:

* Squamous cell carcinoma
* Adenocarcinoma Stage T1,
* T4 with one of the following:

with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)

* Unresectable primary rectal cancer or Inability to complete R0 resection.
* Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis
* Recurrent rectal cancer
* Previous pelvic malignancy
* Inability to sign informed consent
* Pregnancy
Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients

Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease. Weeks to months after gluten withdrawal from the diet before the clinical manifestations, histological features start improving. Many of the adult patients are in the critical phase where even weeks may matter especially those in their adolescence where height growth has limited potential.

Suppression of immune system using a short course of steroid might retard the immune mediated destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to be effective in the management of refractory celiac disease. Therefore, the investigators hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations

Celiac disease is a chronic systemic autoimmune disorder induced by gluten proteins present in wheat, barley, and rye. Steroids affect proliferative responses of both B and T cells in vitro, and the production of lymphokines (migratory inhibitory factor) by cultured cells. Steroids inhibit the effect of gluten proteins through their action on elements of the immune system. Glucocorticoids are reserved for severely ill patients, who present with celiac crisis, gliadin shock, and refractory sprue. We hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations.

Eligibility Criteria:
Inclusion Criteria:

* Naïve patients with celiac disease (CD will be diagnosed as per revised European Society of Pediatric Gastroenterology and Nutrition criteria
* Both sexes
* Age\>12 years

Exclusion Criteria:

* Partially treated celiac disease
* Co-existent systemic diseases
* HIV seropositive
* Seropositive with HBsAg , Anti HCV Ab
* Past H/O tuberculosis
* Evidence of active tuberculosis
* Unwilling patient
Safety and Efficacy of RT-CGMS in Patients With Type 1 Diabetes Mellitus Treated With an Implantable Pump

To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.

Background: Strict glycaemic control reduces risk of complications and improves quality of life in patients with type 1 diabetes mellitus. Real Time Continuous Glucose Monitoring System (RT-CGMS) is a novel system which can provide patients and health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. Furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. Its effectiveness and safety have never been tested in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.

Objective: To investigate the effectiveness and safety of the RT-CGMS in patients treated with intraperitoneal continuous insulin infusion (CIPII).

Study design: Open label, randomized cross-over, single-center controlled trial.

Study population: Patients on CIPII. Intervention: There are 3 study phases. In the Baseline phase, all patients will have the RT-CGMS blinded so that no information on blood glucose values measured and stored by the RT-CGMS will be available to care-givers, investigators or patients during this study period. Randomization will determine the sequence of blinded and unblinded RT-CGMS in the 2nd and 3rd phase. When the RT-CGMS is not blinded, the system will alert whenever a glucose level falls below or rises above preset values. Sensor values are not intended to be used directly for making therapy adjustments. Whenever a value is below or above the preset value, the blood glucose level will be measured using a blood glucose meter and therapy adjustments based on this value will be done according to protocol.

Study endpoints: Primary: Percentage of time spent in euglycaemia. Secondary: percentage of time spent in hypoglycaemia and hyperglycaemia, incidence and severity of hypoglycaemia (as measured with SMBG), incidence of adverse effects, number of measurements of blood glucose (SMBG) performed, number of adjustments of insulin therapy, patient satisfaction, agreement of paired SMBG and RT-CGMS measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
* Age \>18 years
* Uncontrolled diabetes mellitus type 1

Exclusion Criteria:

* Failure to obtain informed consent
* Any condition prevention proper handling of the device, for instance hearing impairment or visual impairment
* Known allergy to sensor (parts)
* Currently pregnant or trying to conceive
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants

The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.


Eligibility Criteria:
Key Inclusion Criteria:

* Receiving chronic dialysis for end stage renal disease (ESRD)
* Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunneled catheter
* Screening hemoglobin criteria (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: \<10.0 g/dL
* Ferritin ≥ 50 nanograms (ng)/milliliter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
* Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN at screening and prior to initiating roxadustat treatment.
* Body weight between 45.0 to 160.0 kg

Key Exclusion Criteria:

* Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
* Known history of myelodysplastic syndrome or multiple myeloma
* Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
* Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
* Active or chronic gastrointestinal bleeding
* Treated with iron-chelating agents within 4 weeks prior to enrollment
* History of New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of myocardial infarction (MI), acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
* Uncontrolled hypertension, in the opinion of the Investigator
* Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
* History of malignancy, except for cancers determined to be cured or in remission for ≥2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Glucocorticoid Treatment in Addison's Disease

Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.

The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Patients with verified Addison's disease on stable treatment.

Exclusion Criteria:

* Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.
* Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart).