cyrilzakka/clinical-trials huggingface dataset:
Changing of Prostate Specific Antigen Value in Patients With Covid-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a worldwide pandemic in over 100 years. The disease caused by this newly discovered virus was called Covid-19. In this study, we aimed to evaluate changing of PSA value in patients with Covid-19.

Patients with positive PCR test results were included in the study. The age of the patient and urea, leukocyte, hemoglobin, platelet, urea, and creatinine values of the patients were recorded. Urinalysis and urine culture were taken from all patients. Acute phase reactants such as sedimentation, C-reaktif protein (CRP), ferritin, and fibrinogen were measured both at the time the patients applied and three weeks after the patient recovered. PSA and free PSA were also measured in the same way. Patients whose symptoms improved and the PCR test result was negative were considered as recovered.

Eligibility Criteria:
Inclusion Criteria:

* Male patients (\>45 and \<70 years of age) positive PCR test results were included in the study

Exclusion Criteria:

* The patients \<45 and \>70 years of age who described lower urinary tract symptoms who had urinary tract infection who a history of prostate biopsy and previous high level of PSA who history of prostatitis were excluded.
Multiple Breath Nitrogen Washout in Healthy Volunteers

This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)


Eligibility Criteria:
Inclusion Criteria:

* Informed consent by participant, parent, or legal guardian
* Healthy subjects with a social insurance

Exclusion Criteria:

* History of a lung chronic disease
* Premature birth (\<37th weeks of amenorrhea)
* Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout
Acid-Base Balance, Metabolism and Minerals

Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.

Within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.


Eligibility Criteria:
Inclusion Criteria:

* slightly reduced kidney function (GFR 60-89 ml/min)
* Body mass index 20.0 - 29.9 kg/m2
* normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively

Exclusion Criteria:

* sorbitol-/fructose-intolerance
* intake of antacidic drugs
* vegetarians, vegans
* intake of any nutritional supplements
* any cardiovascular, pulmonary, endocrine or metabolic diseases
* any drug abuse
* intake of any anticoagulant drugs
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
* Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors

The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer diagnoses
* not currently receiving active treatment in the form of chemotherapy or radiation therapy
* at least 18 years of age
* fatigue severe enough to limit daily activities (score ≥ 4 on 7-point Fatigue Severity Scale)(Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989);
* functional English fluency and literacy;
* Participant has a smart device that operates on the Android or Apple platform
* Participant is able to use the Ecological Momentary Assessment application before going to bed every night

Exclusion Criteria:

* self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment,
* Disability due to a diagnosis other then breast cancer
* Currently taking medication for depression, sleep issues, or fatigue.
MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions

A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
* Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
* Serum ferritin \> 1,000
* Written informed consent by the patient.

Exclusion Criteria:

* Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
Head and Neck Cancer Patient Symptom and Oncologic Outcomes

This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

PRIMARY OBJECTIVES:

I. To develop a specialized and mobile 3D surface scanning application to assess and monitor head and neck lymphedema.

II. To confirm optimal positioning when volumetrically assessing head and neck lymphedema using 3D technologies as consistent with standard plastic surgery departmental protocol.

III. To quantify and serially track changes in head and neck lymphedema in patients with pathologies and correlate these changes with overall patient well-being and disease progression.

OUTLINE:

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologies leading to head and neck lymphedema
* Individuals with minimal or no facial hair
* Patients of sound mentation, who are able to execute informed decision-making

Exclusion Criteria:

* Any health conditions or history of non-compliance that affect the study will preclude study participation
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)

This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.

The study will evaluate the efficacy and safety of SR419 in PHN patients. Each subject will participate in the study for up to approximately 14 weeks. This includes a screening period, drug treatment period, and post-treatment safety follow-up period. This is a crossover design study, in which subjects will be administered with SR419 and placebo according to their randomized sequence, that is, eligible subjects will be randomized in a 1:1 ratio to 1 of 2 double-blind treatment sequences: 30 mg of SR419 administered TID followed by placebo administered TID or placebo administered TID followed by 30 mg of SR419 administered TID.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female over 18 years old;
2. Having neuropathic pain of postherpetic neuralgia (PHN) that persists for \>3 months after the herpes zoster rash is healed, with the pain area of a continuous area of affected rash.
3. DN4 score is ≥4 at Screening;
4. Average PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at Screening is ≥4 and ≤9;
5. Female subjects must be non-pregnant and non-lactating;

Exclusion Criteria:

1. Other pains that cannot be clearly differentiated from PHN and may interfere with PHN assessment;
2. Circumstances that may affect pain assessment as determined by the investigator, such as skin disorders in the affected skin area that may affect sensation;
3. Active herpes zoster infection at screening;
4. Serious acute or chronic medical condition that, as assessed by the investigator, could increase the risks in subjects for participating in the trial or taking the study drug, or interfere with the study results;
5. Previous administration of other study drugs within 30 days or 5 half-lives before the study intervention used in this study (whichever is longer).
Urine Incontinence Occurrence and Sexual Hormones in Women with Chronic Spinal Cord Injury/disease - a Pilot Study

There is a knowledge gap about the influence of the menstrual cycle on bladder function in women with spinal cord injury. So far, studies regarding urinary incontinence have primarily focused on women after menopause. It has become clear that a lack of the sex hormone estrogen, which occurs after menopause, can lead to urinary incontinence. During the course of the menstrual cycle, women also experience fluctuations in their sex hormones, particularly estrogen. The estrogen level is highest before ovulation and decreases afterwards. The investigators aim to explore whether this drop in hormone levels could lead to more frequent urinary incontinence during this phase. In order to offer the patients optimal treatment for urinary incontinence, it is important to understand the potential causes behind it. Participants will document their menstrual cycles and episodes of urinary incontinences over three menstrual cycles using a diary, saliva samples, and urine tests. This research project is a pilot study and is being conducted by Swiss Paraplegic Research at the Swiss Paraplegic Centre. The investigators are recruiting 12 participants who experience incontinence at least once a month and 12 participants who experience incontinence less frequently or not at all.


Eligibility Criteria:
Inclusion Criteria:

* women
* age ≥ 18 years
* chronic neurogenic bladder dysfunction due to acquired spinal cord injury
* regular menstrual cycle (26-30 days/cycle)
* written consent given
* UI group only: UI at least once per month

Exclusion Criteria:

* Detrusor overactivity in storage phase above 15cmH20
* Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods)
* Hormonal intake/contraception
* Intake of androgens
* Intake of drugs which interfere with female sex hormones significantly
* Individuals who underwent sex reassignment surgery
* Pregnant or breastfeeding women
* Women who are trying to conceive
* Gynaecological carcinoma
* Endometriosis
* Ovariectomy
* Current pelvic floor physiotherapy
* Reconstructive surgery of bladder
* Local irritation of the bladder, such as bladder tumour, bladder stones, acute urinary tract infection at study start
* Inability to follow study procedures (cognitive or language barriers)
Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

Eligibility Criteria:
Inclusion Criteria:

* Space deficiency in the upper arch \> 5 mm, and \< 8 mm.
* Non-extraction lower arch.
* Full upper dentition up to the second molars.
* Third molar present in both sides, not yet erupted.

Exclusion Criteria:

* Systemic disease or syndrome.
* Evidence of root resorption.
* Poor oral hygiene.
* Previous orthodontic treatment
* Evidence of bone loss.
* Active periodontal disease.
* Pregnant females.
* Presence of oral habits
Evaluation of How Different Dosages of Spinal Manipulation Modulate Spinal Stiffness in Participants With Back Pain

This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of three different spinal manipulative therapy dosages based on their group assignment and preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will include spinal stiffness measurement and clinical status evaluation through questionnaires.

Spinal manipulative therapy (SMT) is based on the premise that clinicians can identify spine mechanical changes and accordingly determine the dosage of its biomechanical parameters: preload force, rate of force application and peak force. In recent years, our research team showed, using an apparatus to deliver specific dosage SMTs, that SMT-related neurophysiological responses depend on the dosage of these parameters. Beside determining the SMT dosage, clinicians have to select the spinal level to be treated which is partly done by applying a light pressure to each spinous process (spinal stiffness assessment). This study consist of a randomized controlled trial including 75 participants with chronic thoracic pain who will be randomized in one of three groups. Based on their group assignment, participants will receive a specific dosage SMT delivered at T7 three times over 2 weeks. These SMT dosages are distinct regarding their speed and/or their peak force in order to generate either a high vertebral displacement or a high muscle reflex response. T6, T7 and T8 spinal stiffness will be measured just before and after treatment and clinical status will be assessed at each session beginning through questionnaires. Session four will include the questionnaires and the spinal stiffness measurement procedure. Both SMT and spinal stiffness measurement will be performed using an apparatus aiming at simulating force-time profiles. Surface electromyography electrodes and accelerometers will be positioned over the upper back skin in order to measure the muscle response and vertebral displacement during SMT and spinal stiffness measurement procedures.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 60 years hold and presenting a constant or recurrent pain in the thoracic area for at least 12 weeks. Thoracic are is defined as the region boarded superiorly by T1 spinous process, inferiorly by T12 spinous process and laterally by the lateral border of the thoracic erector spinae muscles. The pain has to be of non organic origin.

Exclusion Criteria:

* Spinal arthritis, aortic aneurysm, collagenosis, advanced osteoporosis, spine surgery, neuromuscular disease, current cancer, uncontrolled hypertension, thoracic radiculopathy, thoracic herniated disc, current infection, thoracic scoliosis, current pregnancy, any contraindication to spinal manipulative therapy of the thoracic spine.
a-tDCS Combined With Aerobic Exercise in Healthy Individuals

The purpose of this study is to assess the effects on the exercise performance of anodal transcranial direct current stimulation combined with aerobic exercise in healthy individuals.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has become increasingly popular in recent years. tDCS shows promising improvements for the motor performance of healthy individuals as well as pathological conditions. Moreover, it is frequently preferred because of its safety advantage, high tolerability as well as being cheap, portable and easily applicable.

Studies have shown that tDCS can modulate the excitability of both cortical and subcortical brain regions. In recent years, there have been scientific studies investigating the effects of tDCS on improving physical performance in healthy individuals, but these studies are limited in number, their results are conflicted and as far as the investigators know there is no study that combines tDCS with exercise.

Moreover, although the mechanisms of tDCS on physical performance are largely unknown, some tDCS devices are open to public usage and a large number of professional athletes have reported using tDCS during their training programs. Therefore, studies are needed to demonstrate the effects of tDCS which combined with exercise on performance.

The aim of this study was to investigate the effects of anodal transcranial direct current stimulation combined with aerobic exercise on physical performance in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* No use of any ergogenic substance in one year
* No history of active exercise training in last 6 months

Exclusion Criteria:

* Pacemaker
* Intracerebral metallic implant
* Using dietary supplementation or medication potentially affecting the CNS
* Musculoskeletal injury within the past 6 weeks
* Lower extremity pain above 3 or more according to numeric pain scale
* History of epilepsy or convulsive crisis
Preventive Sodium Lactate and Traumatic Brain Injury

The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.

* Intracranial hypertension is the most severe complication of severe head injury. This may lead to cerebral death or severe neurological outcome. To improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. Recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes.
* Methods and Objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in ICU. The primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in ICU. Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance
* Protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. Management of patients is the same for all patients. Treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. Sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. Based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group
* Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)

Eligibility Criteria:
Inclusion Criteria:

* severe head trauma with a glasgow coma scale less than 9

Exclusion Criteria:

* prehospital cardiac arrest
* severe hemorrhage shock
* severe circulatory or respiratory failure
* medullar trauma
* prehospital osmotherapy
Inflammatory Cytokine Quantification in Infants

This study proposes to quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).

Very small blood samples (500 microliters) will be collected serially in these patients and analyzed with current cytokine array technology. A convenience sample of 60 patients, 20 with each of these diagnoses, will be collected over a 2 year period. These data will provide baseline information for possible therapeutic intervention with agents that enhance or suppress specific mediators, or adjust mediator balance to promote patient healing.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 34 weeks,
* Indwelling vascular catheter available for blood draws,
* Documented culture positive sepsis on vasopressors , and/or
* Congenital diaphragmatic hernia (CDH), and/or
* ECMO therapy

Exclusion Criteria:

* Other major congenital anomalies
* Lack of parental consent