cyrilzakka/clinical-trials huggingface dataset:
ESCAPE Migraine Trial

The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.

Migraine headache is a neurological disorder characterized by chronic and disabling headache. Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this disorder. Despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. In the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale.

A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. Typically, this opening closes shortly after birth, however, in some people, it remains open.

While there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of PFO and migraine with aura.

Comparison: This clinical study will compare PFO closure with medical therapy alone for the treatment of migraine headaches.

Eligibility Criteria:
Major Inclusion Criteria:

* Patient must be between the ages of 18 and 70;
* Patient must have a migraine history and demonstrate a refractoriness to medical treatment;
* Patient must have a Patent Foramen Ovale (PFO);
* Patient must be willing and able to give informed consent and complete required follow-up visits.

Major Exclusion Criteria:

* Patient has any medical condition or receives any medication that would preclude participation in the trial
* Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
* Patient is pregnant, or intends to become pregnant during the trial period
High Versus Low Dose of Caffeine for Apnea of Prematurity

The optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants.

A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* newborn infant less than 32 weeks gestation with the diagnosis of apnea

Exclusion Criteria:

* newborn infants with gestational age more than 32 weeks.
* newborn infant with congenital malformations or chromosomal anomalies.
Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

The objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with heart disease and hypercholesterolemia.

The investigators hypothesize that their data will discover that patients receiving ezetimibe require additional dietary supplementation with omega-3 supplements to insure that these beneficial fatty acids are available to these patients.

All patients will undergo drug therapy as required to treat their clinical symptoms including the use of other classes of cholesterol-lowering drugs like statins (that will not interfere with intestinal cholesterol levels). One group of patients will be those who in addition to there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol concentrations. A second group of patients will be those who are not prescribed ezetimibe as part of their normal course of therapy. Blood samples will be taken from all patients at the study baseline. All patients will be fasted for 12 hours prior to the blood sample being taken. After 6 weeks a second blood sample will be taken. This will determine if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration.

It will also be of interest to determine if drug administration (ezetimibe) will influence this process when higher levels of omega-3 fatty acids are given to the patients by dietary supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement containing 1g of ALA in the form of two capsules daily

Eligibility Criteria:
Inclusion Criteria:

* The subject is between 18-80 years old
* The subject lives in Winnipeg area
* The subject is willing to seize intake of oils/ salad dressings/ seafood
* The subject is willing to comply with the study schedule

Exclusion Criteria:

* The subject had been taking flax oil in the last month
* The subject is not willing to undergo dietary restrictions
Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

The investigators research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing a baseline visual examination with Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. Patients will then begin their normally scheduled treatment with avastin, and other chemotherapeutic agents, as well any radiation treatments scheduled. Once patients have completed their treatment with avastin for 6-8 weeks, they will then undergo their second Visual Evoked Potential testing, with both studies then being compared for any changes within the optic nerves. Patients will also be recommended to have stringent follow up with an Ophthalmologist to include confrontational visual field testing, external and anterior segment examination, and dilated fundus examination. The investigators main objective is to assess whether or not bevacizumab causes a direct toxic effect on patient's optic nerves leading to an acute/subacute optic neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin

Exclusion Criteria:

* No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.
Muscle-targeted Nutritional Therapy for the Recovery From COVID-19

To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients


Eligibility Criteria:
Inclusion Criteria:

* Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
* Recent discharge from hospital for COVID-19
* Informed consent

Exclusion Criteria:

* Any malignant disease during the last five years
* Known kidney failure (previous glomerular filtration rate \<30 ml/min);
* Known liver failure (Child B or C)
* Psychiatric disease
* Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
* Indications related to the study product:

More than 10 µg (400 IU) of daily Vitamin D intake from medical sources. More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.

* Known allergy to milk, milk products or other components of the proposed interventions
* Indication to or ongoing artificial nutrition support
* Inclusion in other nutrition intervention trials
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Refusal
SPC2996 in Chronic Lymphocytic Leukaemia

The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and most of Western Europe. Many patients suffering from CLL have tumour cells expressing high amounts of Bcl-2 protein. Since over expression of Bcl-2 inhibits apoptosis, it is possible that this gene participates in the pathogenesis of CLL. By lowering the Bcl-2 protein in these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti apoptotic proteins and thereby it might be possible to induce a tumour response.

The study is an open-labelled, international, multicenter, dose escalating phase I/II study where patients receive 6, 3, 2 or 1 dose(s) of SPC2996, a LNA antisense molecule against Bcl-2, over a period of up to 2 weeks, and are followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patients with relapsed or refractory Chronic Lymphocytic Leukaemia requiring therapy
* screening blood sample must show circulating lymphocyte count of more then 5 x 109/L and circulating lymphocytes expressing the phenotype CD5+CD20+CD23+.
* The PCR Bcl-2 m-RNA level must be positive
* the patients must be 18 years or older and have given informed consent.

Exclusion Criteria:

* previous treatment with rituximab, alemtuzumab or autologous stem cell transplantation within 6 months prior to Visit 1 or allogeneic stem cell transplantation at any time
* patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4 weeks prior to Visit 1 and patients with known or suspected transformation of CLL
The Effect of Genetic Variation in TMPRSS6 Gene (SNP rs855791) on Oral Iron Absorption: an Iron Stable Isotope Study

Iron deficiency is considered the most common nutritional deficiency worldwide and affects children and women in both non-industrialized as well as industrialized countries. The main regulatory molecule of iron metabolism is hepcidin, a hormone produced in the liver that regulates intestinal iron absorption, placental transport, recycling of iron by macrophages and release from stores. The expression of hepcidin is regulated by many mediators, one of which is Matriptase-2 - a transmembrane protease. Complete loss of function leads to the rare disease iron-refractory iron deficiency anemia (IRIDA). Matriptase-2 is encoded by the gene TMPRSS6 and the single nucleotide polymorphism (SNP) rs855791 causes a non-synonymous substitution (V736A) that reduces the activity of the protease to inhibit hepcidin transcription. Genome wide association studies have identified the TMPRSS6 SNP rs855791 has a strong association with red blood cell and iron parameters in the general population.

The objectives of the study is to measure oral iron absorption and systemic iron utilization into red blood cells (RBC) using oral isotopic labels in subjects homozygotes for common variants of the TMPRSS6 gene with the SNP rs855791 (A736V); AA vs. VV subjects.

The aim is to conduct an iron absorption study in 80 Taiwanese women of reproductive age, non-pregnant, non-anemic, investigating the effect of the genetic variants of the SNP rs855791. The participants will be split in two groups of equal size; wild type AA vs. mutation VV. Iron absorption and systemic utilization will be assessed by two test meals containing stable isotopes of iron.The primary outcome of the trial is the oral iron absorption from a test meal as compared between the two genotypes AA vs. VV. Secondary outcomes are the comparison iron status markers between the two genotypes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects homozygotous for the for AA (CC), or VV (TT) variant of the SNP rs855791 of the TMPRSS6 gene.
* Females 20 - 45 years of age (premenopausal status)
* obtained informed consent
* regular menstrual cycle, ± 2 days

Exclusion Criteria:

* Pregnancy or lactating (assessed by pregnancy test and self-declaration, respectively)
* Anemia defined as Hb \< 120 g/L
* Plasma ferritin \< 30 µg/l, or \> 120 µg/l
* C-reactive Protein \> 5 mg/l
* Body weight \> 65 kg
* Body mass index (BMI) 18.5 - 25
* Diagnosed metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal.
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months, prior the first study day.
* Subjects who cannot be expected to comply with study protocol (e.g. non-residents).
* Use of long-term medication during the study
* Subjects that will take part of another clinical study at the same time or had within the last 30 days before the first study day
* Intake of mineral/vitamin supplements 2 weeks before the first study day and during the study
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995)

Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Able to provide informed consent after risks and benefits of the study have been explained.
* Be willing to undergo all study procedures.
* Ability to communicate effectively with study personnel.
* Have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Clinically significant dermatologic condition in donation or study areas.
* Prior surgery in the donor or study areas.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Immunity and Nasal Fungal Colonization

Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants
* Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation.

Exclusion Criteria:

* Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.
Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages

The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy

The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy

Eligibility Criteria:
Inclusion Criteria:

* patients who meet the diagnosis, stages, location criteria
* the first time to onset the disease
* between 1 and 70 days with the onset time of facial palsy
* on one side of the face paralysis
* between 15 and 70 years old with the onset age of facial palsy
* willing to finish the whole observation period
* with written consent form signed by themselves.

Exclusion Criteria:

* facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
* facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
* patient with Hunt's syndrome
* patient with facial spasm
* pregnant women or women in lactation
* patients are participating other clinical research
The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males

To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL). To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway. To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* • At least one-year of resistance training experience

  * Free of any physical limitations (determined by health and activity questionnaire).
  * Between the ages of 18 and 35.
  * Ability to leg press a weight equivalent to 1.5 times their body mass

Exclusion Criteria:

* • Inability to perform physical exercise (determined by health and activity questionnaire)

  * Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
  * Physical injury preventing the athlete from participating in offseason training
  * Any chronic illness that causes continuous medical care
The Role of the Seven Sweeps in the Prevention of the Prostate Cancer Among Those With a Positive Family History

The seven sweeps is a recommended act performed by men after urinating in order to be confident that no urine is left in the urethra, and its not compulsory to perform. It is performed by the following way: after urinating, the anus is first purified if it has become impure; then, the middle finger of the left hand is slid three times from the anus up to the scrotum; then, the thumb is placed on the penis and the forefinger is placed under the penis, and the thumb and forefinger are pulled three times along the penis up to the point of circumcision; finally, the end of the penis is pressed three times.

The investigators have investigated 350 people who have been doing this habit for at least 20 years of their life and they have a family history of prostatic cancer to check the effect of this procedure on the prevention of the cancer. The investigators have excluded 135 participants of them because they have not full-filled the criteria of inclusion. So 215 of them have been included and investigated using PSA and prostate ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Family history of prostate cancer, more than 40 years of age, is doing the seven sweeps habit for at least 20 years, has not any urinary problems or chronic diseases.

Exclusion Criteria:

* No family history of prostate cancer, less than 40 years of age of more than 70 years old, has a urinary problem or chronic diseases.
Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia

Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia （CEBPAdm AML）has favourite prognosis, especially in younger adult patients. But cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.

In this phase 2 study, 40 patients will be enrolled and treated with HAD induction regimen. High dose cytarabine will be given after complete remission achieved. The primary endpoint was event-free and relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be detected at diagnosis and after chemotherapy. The risk stratification according to genetic mutations and MRD will also be explored.

induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4；1g/m2 /q12h ，day5-7 DNR 40mg/m2/d，day 1-3 re-induction chemotherapy:IDA 10mg/m2，day 1-3 cytarabine 100mg/m2，day 1-7 CTX 350mg/m2，day 2，day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/Q12h,day1-3,for three cycles

Eligibility Criteria:
Inclusion Criteria:

* newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia
* with CEBPA double mutation
* age≥ 14 years and\<55 years，male or female
* ECOG-PS score 0-2
* laboratory tests（within 7 days before chemotherapy）

  1. serum total bilirubin≤1.5xULN；
  2. serum AST and ALT≤2.5xULN
  3. serum creatinine≤2xULN；
  4. cardiac enzymes≤2xULN
  5. ejection fraction \>50% by ECHO。
* written informed consent。

Exclusion Criteria:

* subject has received remission induction chemotherapy
* secondary AML
* with other hematological malignancy
* with other tumors(needing treatment)
* pregnant or lactating women
* active heart diseases
* severe active infection
* unfit for enrollment evaluated by investigator
Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS

Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection

Eligibility Criteria:
Inclusion Criteria:

* obese women under elective CS

Exclusion Criteria:

* immunodeficient women