cyrilzakka/clinical-trials huggingface dataset:
Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

The goal of the study is to quantitatively evaluate pituitary hormone response, follicle stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in normally fertile women.

Empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance fecundity in women with unexplained infertility. No clinical trials have examined the efficacy of such treatment in the patient population, although certain studies have shown that active ovulation induction can be effective in women with unexplained infertility, and that cycle fecundity is improved for normally cycling women with active ovulation management in a program of artificial insemination. Since clomiphene citrate can have paradoxical effects on fertility through its anti-estrogenic mode of action, the benefit or lack of benefit from treatment with clomiphene citrate in this patient group needs to be evaluated. We aim to establish a dose response of FSH and LH to various low doses of clomiphene citrate in normally cycling women of known fertility, that is women with an intact hypothalamic-pituitary-ovarian-axis. The significance of this information is that it may help to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in patients with unexplained infertility as it is currently being used empirically.

Eligibility Criteria:
Inclusion Criteria:

* Normal cycling healthy women with known fertility
* Regular menses every 24 - 35 days
* 18 to 35 years of age
* be within 20% of ideal body weight
* normal TSH, prolactin and mid luteal phase progesterone

Exclusion Criteria:

* Women with Infertility issues
* Irregular menstrual cycles
Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).

This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 65 years of age
* First histologic diagnosis of MCNS
* Proteinuria \> 3.5 g/day
* Patients who are willing to give written, informed consent

Exclusion Criteria:

* Presence of secondary causes of MCNS
* History of glomerular disease including MCNS
* eGFR \< 50 ml/min/1.73m2
* Renal histology showing pathologies other than MCNS
* Female of child-bearing age who are unwilling to practice effective contraception
* Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.

Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)

Method :

1. Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
2. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
3. After first blood sample, patients will received everolimus only for 1 month (wash out period)
4. Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
5. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
6. Everolimus level will analyse for 12-hour AUC of everolimus.

Eligibility Criteria:
Inclusion Criteria:

* Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
* Co everolimus level within 3-12 ng/mL
* Informed consent
* Patient can follow research methodology

Exclusion Criteria:

* Patient don't want to participate in the study
* Post renal transplantation recipient who have normal lipid profile
Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery

This study aims to investigate the effect of adjuvant continuous lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery

Craniotomy for resection of brain tumors is frequently performed in neurosurgical practice. Craniotomy surgery is currently starting to use the Enhanced Recovery After Surgery (ERAS) protocol, namely for intraoperative pain management. Intraoperative pain can be evaluated through intraoperative hemodynamic conditions or can also use qCON and qNOX parameters and blood sugar levels. Perioperative pain management in the form of continuous intravenous lidocaine shows a role in reducing intraoperative pain. However, the use of intravenous lidocaine in ERAS protocols is still debated. So this study aims to use general anesthesia with continuous IV lidocaine adjuvant general anesthesia to affect depth of anesthesia (qCONtm) and intraoperative pain response in the form of values (qNOXtm), and blood sugar levels during elective primary tumor craniotomy.

The method is a Double-Blinded Randomized Control Trial. 60 patients aged 18-65 years who were diagnosed with craniotomy supratentorial tumor were randomly allocated to either Adjuvant Continuous Lidocaine (intervention group) or Normal Saline 0.9% (control group). Both drugs are given in a 20 ml syringe. The primary outcome measure of the study was the intraoperative of qCON, qNOX, and Blood Sugar. While the secondary outcome was the intraoperative hemodynamic.

All patients will be induced by general anesthesia using fentanyl 3 μg/kg IV as coinduction and propofol 1 mg/kg until the patient falls asleep. After induction, patients who receive lidocaine will receive a continuous intravenous infusion of 2 mg/kg/hour of lidocaine while other patients are given 0.9% NaCl as control. All patients data of hemodynamics, qCon, QNox, and blood glucose recorded and will be analyze.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 - 65 years with a diagnosis of brain tumor supratentorial who will undergo craniotomy by opening the dura
* ASA physical status 1-3
* Surgery using a head pin
* The level of consciousness was assessed with the Glasgow Coma Scale 15

Exclusion Criteria:

1. The patient's family or guardian refuses informed consent included in the research
2. The patient has atrioventricular block
3. There is a midline shift \> 5.4 mm
4. Diagnosis of glioblastoma multiforme or metastases
5. History of allergies to drugs used in the study
6. The patient routinely consumes or is administered class of drugs adrenergic agonists or antagonists (e.g., beta blockers, α-2 agonists, vasodilator, vasoconstrictor or inotropic).
7. The patient has been regularly consuming analgesic agents for the past 2 weeks.
8. The patient has a history of cardiac arrhythmia, kidney or liver disease based on the results of the history and confirmed by further examination.
9. Suffering from diabetes mellitus or taking anti-drugs hyperglycemia based on preoperative assessment.
The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old (including the cut-off value), regardless of gender;
2. Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China;
3. Informed consent has been signed.

Exclusion Criteria:

1. Known or suspected allergic to the components of Azivudine tablets;
2. Patients with severe liver, kidney, heart and other organ damage;
3. Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
4. Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;
Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Exclusion Criteria:

* Smoking
* Pregnancy
TRF-1101 Assessment in Sickle Cell Disease

This study is designed to assess the safety, tolerability, and activity of TRF-1101 on microvascular blood flow, vascular endothelial injury, and vasoocclusive pain associated with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older at the time of informed consent;
* Have a diagnosis of homozygous sickle cell anemia or sickle cell-beta° thalassemia;
* Have had 2 - 10 documented pain crises in the past year (pain crises are defined as visits to a medical clinic, Emergency Department or hospital, being bedridden and requiring constant analgesia at home for at least three days, or having a three-day interruption of life's activities \[i.e., school, work, planned leisure activity\] because of pain);
* If female and of child bearing potential, have a negative serum or urine pregnancy test and be using an effective birth-control method with a history of reliability for the individual patient (use of mifepristone is not allowed);
* Be properly informed of the nature and risks of the clinical investigation, be willing and able to comply with all clinical investigation-related procedures and assessments, and sign an Institutional Review Board (IRB) approved Informed Consent Form prior to entering the clinical investigation.

Exclusion Criteria:

* Have a history of abnormal bleeding, stroke, moya moya vascular malformations, or any other contraindication to anticoagulation;
* Be currently taking anticoagulant or thrombolytic medication;
* Be currently taking an endothelin receptor antagonist, e.g., bosentan (Tracleer®);
* Have a known sensitivity or allergy to heparin or related drugs;
* Have a history of thrombocytopenia (platelet count \< 100 x 103/mm3) induced by heparin or related drugs;
* Have had fewer than 2 documented pain crises in the past year;
* Have had a pain crisis within one month of screening or randomization;
* If currently on or recently discontinued hydroxyurea treatment, have initiated or discontinued treatment or changed regimen within the past 6 months;
* Have had a transfusion within last 120 days or have HbA% \> 15% from prior transfusion;
* Creatinine levels \> 1.53 mg/dL (135 umol/L);
* ALT levels ≥ 3 times normal;
* Platelet count \< 100 x 103/mm3;
* INR \> 2.0;
* Be unable to tolerate oral medications;
* Have unreliable venous access;
* Be noncompliant with regular care;
* Have a positive pregnancy test, be currently lactating, or be trying to become pregnant;
* Have participation in an investigational drug or medical device study within previous 30 days;
* Have any other condition or circumstance that in the opinion of the Investigator makes the patient a poor candidate for participation in the study.
NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia

A Study of NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia.

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory NKG2D ligand positive acute myeloid leukemia. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of NKG2D ligand positive AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
2. Relapsed or refractory NKG2D ligand positive AML (meeting one of the following conditions):

   1. CR not achieved after standardized chemotherapy;
   2. CR achieved following the first induction, but CR duration is less than 12 months;
   3. Ineffectively after first or multiple remedial treatments;
   4. 2 or more relapses;
3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flow cyto metry);
4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
6. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
7. Estimated survival time ≥ 3 months;
8. ECOG performance status 0 to 2;
9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after. The patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. The antibody response will be again measured one month after the 1 year booster dose.

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive, 6 months after the graft, 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months, followed by a booster dose one yrar after. However, this strategy do not constantly lead to efficient antibody levels.

the investigators aim to determine whether a 4th dose in the initial vaccine schedule (month 0, 1, 2, and 3) allows to obtain a better response.

After informed consent, the investigators will recruit 6 months after the graft 200 patients who had received an hematopoietic stem cell transplantation . The participants will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) at month 0 (before the 1st hexavalent vaccine injection), and one month after the 3rd injection of this vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month.

The one year booster dose will be then injected to all participants, and the antibody response will be again measured one month after this dose. The primary endpoint is to compare the antibody levels at this date in patients who had an unsufficient immune response after the 3rd dose and who received or not a 4rth dose in the initial vaccine schedule.

Eligibility Criteria:
Inclusion Criteria:

* having received an HSTC 6 months before (not more than 2 years)
* not receiving immunosuppressive therapy at inclusion

Exclusion Criteria:

* having received an HSTC 6 months more than 2 years before
* receiving immunosuppressive therapy at inclusion
Cycling Deep Brain Stimulation on Parkinson's Disease Gait

Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (\>130Hz) stimulation, 2) cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)

Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
* Hoehn \& Yahr stage between 2-4 during off-medication
* Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
* Willingness to comply with all study procedures

Exclusion Criteria:

* Active moderate/severe psychiatric condition
* Active infection or other uncontrolled moderate/grave comorbidities
* Treatment with experimental drug
* Pregnancy or breast-feeding
Quantifying Micro RNA Levels of Colon

Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of cancer-related death in the world. Despite potentially curative surgery and the use of modern adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or metastatic disease. Currently, aside from post-operative pathological staging, early follow up of the patients does not include a specific test or any other evaluation that could predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's following diagnosis of the primary tumor may help us in identifying patients at high risk for recurrence.

Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular. It has been established, although not completely, that miRNAs have a role in initiation and progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As miRNAs are well documented to regulate critical molecules in signaling pathways, their regulation of tumor relevant pathways may also serve to further sub-classify patients into drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are available as a non-invasive diagnostic method, their application as biomarkers is of special interest.

In this study the investigators aim to quantify miRNA levels in human colon and rectal tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of patients, the investigators aim to identify specific, relevant miRNAs that may serve as biomarkers to stratify CRC patients according to their clinical characteristics such as disease stage, specific treatment, prognosis and disease recurrence.


Eligibility Criteria:
Inclusion Criteria:

Adult men and women over the age of 18 years who underwent colon resection of any kind are suitable candidates for this study.

Exclusion Criteria:

Pregnant woman and children (under the age of 18 years) will not be included in this study.
Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy in the world.

It is a malignant clonal proliferation of lymphoid progenitor cells, but most commonly of the B cell lineage (B ALL). .

Acute Lymphoblastic Leukemia (ALL) is a heterogeneous disease that causes malignant hematological disorders at any age. It mainly affects children aged 2 to 5; in fact, 60% of pediatric leukemia cases are ALL, with an incidence of 3-4 cases per 100,000 per year. It is divided into two subtypes B-ALL and T-ALL depending on whether transformation occurs in B- or T-cell precursors, respectively .

Leukemic cells apply multiple immune evasion mechanisms resulting in tumor progression. One of the most important immune escape mechanisms is over expression of immune checkpoint receptors and their ligands such as PD-1 and PD-L1 .

The PD-1 receptor plays a crucial role in a broad spectrum of immune regulatory mechanisms .

It is a negative co-receptor that down regulates T-cell activity .

PDL 1, which is known as B7 H1 , is a cell surface protein of B7 family member .

PD L1 is expressed on all types of lympho hematopoietic cells at variable levels and is constitutively expressed on T cells, B cells, macrophages, and dendritic cells .

Tumors exploit the PD-1/PD-L1 pathway to evade host immune surveillance .

PD-1/PD-L1 pathway controls the induction and maintenance of immune tolerance within the tumor microenvironment. The activity of PD-1 and its ligands PD-L1 or PD-L2 are responsible for T cell activation, proliferation, and cytotoxic secretion in cancer to produce anti-tumor immune responses .


Eligibility Criteria:
Inclusion Criteria:

* Age range from 1 day to 18 years old
* Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia

Exclusion Criteria:

* Other types of acute leukemia rather than acute lymphoblastic leukemia