cyrilzakka/clinical-trials huggingface dataset:
A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.


Eligibility Criteria:
Inclusion criteria:

1. Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
2. Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trial period.
3. Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered.
4. Women of childbearing potential should use a highly effective or acceptable method of contraception during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month (as listed in the protocol)

6. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).

7. Patient has completed a 52-week treatment period.

Exclusion criteria:

1. Introduction or continuation of non-permitted medications during the ARGX-113-1801 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins or live/live-attenuated vaccines).
2. Pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
3. Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
4. Use of any other investigational drug or participation in any other investigational trial.
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori

High protein diets are popular among Maori, especially on the East Coast of the North Island. The purpose of this study was to compare the metabolic effects of a moderate carbohydrate, high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.

This was a 6-month pilot intervention study of self-identifying Maori participants in a randomised control trial conducted in Dunedin and Invercargill. The study consisted of three, two month phases and was conducted over a period of six months. Participants meeting all the inclusion criteria were randomised into three groups: moderate carbohydrate-high protein (MCHP), high carbohydrate-high fibre (HCHF) or a control group. Those randomised to the experimental diets were recommended an energy intake based on their current BMI levels. The aim of phase one was to achieve weight loss with weekly advice and support from the research team. The aim of phase two was for weight maintenance with continued weekly advice and support. Phase three consisted of a weight maintenance phase without support. Those in the control group were instructed to follow their own self selected diet plan.

Outcome was determined by examining surrogate clinical endpoints. The clinical endpoints included the following recorded measurements of anthropometric measurements, bioelectrical impedance measurements, profile of mood state questionnaires, activity questionnaires, and three day diet records were collected at 0, 2, 4 and 6 month periods. Biochemical measures of lipid profile, fasting insulin and glucose, liver functions and uric acid levels were also conducted.

Eligibility Criteria:
Inclusion Criteria:

* Self identify as Maori aged between 17-75 years
* Male and female
* Non-diabetic
* Resident of Dunedin and Invercargill
* BMI \>27
* Family history of T2D

Exclusion Criteria:

* The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which potential partcipants are currently having active treatment.
Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)

The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.

Specific research objectives are to:

* determine financial costs of performing a CEM to breast MRI
* compare time costs involved with CEM to breast MRI
* compare psychologic costs involved with CEM to breast MRI.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal to 30 years
* Clinically eligible for CEM or breast MRI
* Newly diagnosed cancer

Exclusion Criteria:

* Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.
Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Study to describe Tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 21 years old diagnosed with benign prostatic hyperplasia (BPH), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. The study will include naïve patients and patients not responding to previous therapy who receive Secotex as alternative or complementary treatment. The decision to treat a patient with Tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following Secotex (Tamsulosin) prescription information

Exclusion Criteria:

* Patients with known hypersensitivity to Tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded
Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation

Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Adult end-stage renal disease patients
* First living donor kidney transplant.
* Moderate immunological risk.

Exclusion Criteria:

* Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).
* High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).

  * Known hypersensitivity to any of the study medication.
Pregnancy Outcomes of Patients Having NC-FET Regarding the Progesterone Levels

We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.


Eligibility Criteria:
Inclusion Criteria:

* patients with regular menstrual cycle
* patients aged btw 20-40
* patients with pregnancy with NC-FET by using the progesterone for the detection of ovulation

Exclusion Criteria:

* Spontenous pregnancies
* Multiple pregnancies
Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment.

OBJECTIVES:

* Evaluate the safety and toxicity of azacitidine plus phenylbutyrate in patients with refractory solid tumors.
* Determine the maximum tolerated dose of this treatment regimen where maximal gene reexpression occurs in these patients.
* Evaluate the pharmacokinetics of these drugs in these patients.
* Determine the minimally effective dose of azacitidine in combination with phenylbutyrate that elicits a biological or clinical response in these patients.

OUTLINE: This is a dose escalation study.

Patients receive azacitidine subcutaneously for 14-21 days and sodium phenylbutyrate IV continuously for 1-7 days. Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses and durations of treatment with azacitidine and phenylbutyrate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: Approximately 3-50 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
Inclusion criteria:

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor not amenable to curative therapy

  * Lymphoma allowed
* Progressive disease
* Evaluable disease
* No CNS metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin at least 8 g/dL (may be achieved by transfusion)
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 mg/dL (unless due to hemolysis or Gilbert's syndrome)
* SGOT and SGPT less than 2 times upper limit of normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* No active infection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 2 weeks before, during, and 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior adjuvant chemotherapy for advanced or metastatic disease and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified
The Effect of Inspiratory Muscle Training in Post COVID-19 Patients

The COVID-19 infection, which is considered as a pandemic by the World Health Organization, affects the whole world. COVID-19 is an infectious respiratory disease caused by SARS-CoV-2. It is stated in early studies that after COVID-19 infection, there are adverse effects on both the peripheral and respiratory muscles along with the pulmonary system involvement. The purpose of our study; To examine the effect of Inspiratory Muscle Training (IMT) on respiratory muscle strength, respiratory functions and functional capacity in PostCOVID-19 patients. Patients who have been hospitalized and discharged with the diagnosis of COVID-19 in Istinye University hospitals, at least 6 weeks have passed since the infection, the PCR test has turned negative will be taken. The evaluation and treatment of the patients will be carried out in the Education and Research Units of Istinye University Physiotherapy and Rehabilitation Department. Patients included in the study will be randomly divided into two groups, study and control groups. Demographic evaluation form, Post Covid Functional Status Scale, Charlson Comorbidity Index, Modified Medical Research Council (MMRC) Dyspnea scale, Corbin posture analysis, Respiratory function test, Respiratory muscle strength measurement, Respiratory Muscle Endurance measurement, 6-minute walking test (6 MWT) ), Peripheral Muscle Strength, Grip Strength, Hospital Anxiety and Depression Scale (HADS), Breathlessness Perception Questionnaire (BBQ) and Nottingham Health Profile Questionnaire will be used. In the study group, IMT will be applied at 40% of the maximum inspiratory pressure (MIP) for eight weeks, every day of the week, twice a day for 15 minutes. The patients will come for a control once a week, the MIP values will be measured again and the new training intensity will be determined at 40% of the new MIP value. The control group will be given a constant training of 15 minutes at 10% of the MIP, twice a day, every day of the week for eight weeks. Evaluations of the study and control groups will be made at the beginning and after eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-70
* Being clinically stable,
* Having COVID-19 infection and at least 6 weeks after infection
* Being between Grade 2-4 according to Post-COVID Functional Status Scale
* Regular participation in treatment
* To read, write and understand Turkish
* Volunteering to participate in research

Exclusion Criteria:

* Presence of mental and cognitive impairments
* Having an orthopedic, neurological disease that prevents exercise
* Uncontrolled hypertension, having a cardiovascular disease
* Pregnancy and breastfeeding
Effects of Seven Day Prucalopride Administration in Healthy Volunteers

This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive seven days administration of either prucalopride (1mg daily) or placebo. All participants will come for a Screening visit, Research Visit One (including an MRI scan) and Research Visit Two (including measures of emotional processing and non-emotional cognition). The primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. A secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. Finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or female
* Aged 18-40 years
* Sufficiently fluent English to understand and complete the task
* Right handed
* Body Mass Index in the range of 18-30
* Not currently taking any medications (except the contraceptive pill)

Exclusion Criteria:

* Not fluent in English
* Any past or current Axis 1 DSM-V psychiatric disorder
* Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
* Current usage of any medication that will influence the MRI scan
* Current or past history of drug or alcohol dependency
* Currently pregnant or breastfeeding
* Study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week)
* Not right handed
* Body Mass Index outside the range of 18-30
* History of cardiac, thyroid, or liver problems
* An autoimmune disorder
* Current, or a history of, gastro-intestinal disorder or irritable bowel syndrome
* Epilepsy
* Known lactate deficiency or any other problem absorbing lactose, galactose, or glucose
* Participation in a study which uses the same computer tasks as those used in the present study
* Participation in a study that involves the use of a medication within the last three months
* Smoker \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day
* Any contraindication to MRI scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)
Sodium Lactate Infusion in GLUT1DS Patients

This study investigates the effect of lactate infusion on epileptic discharges on EEG and seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.

In glucose transporter 1 deficiency syndrome (GLUT1DS) cerebral glucose uptake from the systemic blood circulation is limited, because of deficient transport of glucose across the blood-brain barrier by the transporter protein (GLUT1). Classically patients present with developmental problems, movement disorders and severe epilepsy. There is no curative treatment for GLUT1DS, and anti-epileptic drugs usually have little to no effect. The ketogenic diet, providing ketones as an alternative energy substrate for the brain is an effective treatment option for the epilepsy and movement disorders in many GLUT1DS patients. Unfortunately, not in all GLUT1DS patients the ketogenic diet has a positive effect and other treatment options for these patients are very limited.

Traditionally, lactate is seen as a waste product of glycolysis during anaerobic conditions and a marker of ischemia. Interestingly, research has shown the beneficial side of lactate as an energy source for different organs. It seems that the brain can indeed use lactate as an alternative energy metabolite, besides glucose and ketones. The aim of this study is to investigate whether lactate can be an alternative energy metabolite in the GLUT1DS brain, and reduce epileptic discharges on EEG when intravenously administered in patients with GLUT1DS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with GLUT1DS and known in our center.
* Baseline characteristics include a high frequency of clinical seizures and epileptic discharges on EEG.
* History of trying ketogenic diet with good compliance without beneficial effects.
* Age \> 6 years.
* Informed consent.

Exclusion Criteria:

* Additional medical condition or illness that impairs the patient's ability to participate in the study (for example actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant haematological or biochemical abnormalities).
* Elevated serum sodium (\> 145 mmol/L).
* Participation in another interventional study at start of the study or during the study.
* Presence of known panic disorders or a history of panic attacks.
Meaning of Recovery After Lung Cancer Surgery

The purpose of this study is to find out the meaning of recovery after lung cancer surgery from a patient's point of view. The results of this study would help improve postoperative recovery in lung cancer patients.

In patients undergoing video-assisted thoracic surgery (VATS) lung resection for lung cancer, the survey on the 'meaning of recovery after surgery' are conducted before surgery, 2 days after surgery, and 30 days after surgery. The questionnaire includes importance score of each question regarding the meaning of recovery after lung cancer surgery.

After 2 days of surgery and 30 days after surgery, the questionnaire about the recovery score and the part where the patients felt difficulties are conducted to investigate what recovery means from a patient's point of view. Length of hospital and ICU stay and postoperative complications are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 80 years undergoing video-assisted thoracic surgery (VATS) lung resection for lung cancer
* Patients who can provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and properly fill out patient-reported questionnaires or respond appropriately to interviews

Exclusion Criteria:

* Patients who did not consent to the trial
* Patients who have difficulty filling out questionnaires or answering interviews about the meaning of recovery
* Patients judged to be inappropriate for this clinical trial based on the opinion of the investigator or investigator
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.


Eligibility Criteria:
Inclusion Criteria:

1. Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require at least 6 hours of continuous IV sedation.
2. Age: subjects must fit the following age range at screening:

   Preterm subjects ≥28 weeks through \<36 weeks, gestational age;

   Note: Gestational age (in weeks) will be calculated as follows: the time elapsed between the first day of the last menstrual period and the day of enrollment.
3. Weight: subject's weight at the time of enrollment must be \>1000 g.
4. Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria:

1. Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:

   * Diminished consciousness from increased intracranial pressure.
   * The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
   * Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.

   Note: If subject's status-post Cardio Pulmonary Bypass (CPB) was managed without pacing wires in situ, the subject must not be suspected to be in second degree or third degree heart block at the time of DEX administration.
3. HR \< 120 bpm prior to the initiation of DEX.
4. Exposure to any investigational drug within 30 days prior to DEX administration.
5. Previous exposure to DEX as part of an investigational study.
6. In subjects that are ex-utero for less than 72 hours, a maternal history of poly-substance drug abuse, based upon the Investigator's clinical judgment.
7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
8. Subjects who have a known allergy or contraindication to fentanyl, morphine, MDZ, DEX, or other α-2 agonists.
9. Requirement for medications other than DEX, MDZ, morphine, or fentanyl for sedation and pain control.
10. Screening ALT levels \>115 U/L.