cyrilzakka/clinical-trials huggingface dataset:
Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.

This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy females with a history of primary dysmenorrhea
* Using effective birth control excluding intrauterine contraceptive device (IUCD)
* Must be 18 years of age or older
* Must give written informed consent to participate in this study

Exclusion Criteria:

* Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study
* Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis
* Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study
* Patients who are breastfeeding
* Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening
* Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study
* Patients who have been exposure to any investigational drug within 4 weeks prior to screening
Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?

A total of 26 patients who were diagnosed with CP \[diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5\] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).

Purpose: This study aimed to investigate the effects of robot-assisted training (RAT) on motor functions, spasticity status, balance and functionality in children with cerebral palsy (CP).

Method: A total of 26 patients who were diagnosed with CP \[diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5\] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).

Outcome measures: GMFCS was used to evaluate motor functions and Modified Ashworth Scale was used to evaluate spasticity. Paediatric Berg Balance Scale, Paediatric Functional Independence Measure and timed up and go test were used to assess balance and functional status. The evaluations were performed at baseline and after 8 weeks of therapy.

Eligibility Criteria:
Inclusion Criteria:

* diplegic CP and who were level 2-5 according to the Gross Motor Function Classification System (GMFCS) were included in the study. Children who presented with any disorder involving the peripheral nervous system or another neurological disorder such as epilepsy were not included.

Exclusion Criteria:

* Patients in whom the dose of their prescribed medication for spasticity was changed during the study period were excluded
Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder affecting healthcare systems worldwide. The efficacy of therapeutic exercise and neuromodulation in the treatment of UUI is evaluated, and these techniques are combined.

Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder that affects the neurophysiology of micturition and bladder functionality, particularly in processes associated with menopause, leading to a deterioration in quality of life. Various therapeutic approaches are employed to treat overactive bladder. Among the most frequently implemented interventions are sacral or tibial nerve neurostimulation. This intervention targets the pathophysiological substrate by modulating the somatic afferent activity of the bladder and interfering with the activity of fibers responsible for pain modulation and neuromuscular system functionality. In essence, the described approach focuses on reducing peripheral input. Based on the aforementioned information, it was hypothesized that training through a pelvic floor strength protocol, performed adjunctively with peripheral neuromodulation prior to its implementation, may provide the ability to inhibit detrusor contractions via involuntary contractions of the perineal musculature.

Eligibility Criteria:
Inclusion Criteria:

* Present with a diagnosis of urinary incontinence or overactive bladder
* Women of menopausal age (\>45 years)
* ≥3 months of duration
* Fulfill the established criteria for patient selection for neuromodulation treatment (urge urinary incontinence)
* Speak native Spanish or English

Exclusion Criteria:

* Prior or scheduled surgical procedures in the lumbar or abdominal region
* Presence of fractures or severe pathological conditions
* Current pregnancy or potential for pregnancy during the study period
* Neurological or psychiatric disorders
* Presence of stress urinary incontinence
* Female subjects with autoimmune diseases or malignancies
* Belonephobia
* Subjects who have undergone previous neuromodulation
Tear Film Innovations iLux Safety Study

The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.

Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Eligibility Criteria:
Key Inclusion Criteria:

- Sign written informed consent prior to study participation

Key Exclusion Criteria:

* History of ocular surgery within 1 year
* Active ocular infection
* Ocular surface abnormality; lid surface abnormalities
* Pregnant, nursing or not utilizing adequate birth control measures
* Other protocol-specified exclusion criteria may apply
Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

After positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).

The injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine).

The study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.

Eligibility Criteria:
Inclusion Criteria:

* proximal femoral fracture
* older then 18 years
* written informed consent

Exclusion Criteria:

* local or systematic inflammation
* allergy to ropivacaine
* participate in other studies
* body mass index over 35
* periprosthetic fractures
Dual Vaccine Trial in Myeloproliferative Neoplasms

A phase I-II study in patients with mutated MPN by vaccinating with PD-L1 and Aginase1 peptides with Montanide ISA-51 as adjuvant, to monitor the immunological response to vaccination and subsequently safety, toxicity and clinical effect.


Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of essential thrombocythemia or Polycythemia Vera, according to the WHO criteria123,124 2. Age ≥18 years 3. Performance status ≤ 2 (ECOG-scale) 4. Expected survival \> 3 months 5. Sufficient bone marrow function 6. Creatinine \< 2.5 upper normal limit, i.e. \< 300 µmol/l 7. Sufficient liver function, i.e.

  1. ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l
  2. Bilirubin \< 30 U/l 8. For women: Agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.

     9. For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm.

     Exclusion criteria
     1. Other malignancies in the medical history excluding basal cell carcinoma. Patients cured for another malignant disease with no sign of relapse five years after ended treatment is allowed to enter the protocol.
     2. Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus.
     3. Acute or chronic viral or bacterial infection e.g. HIV, hepatitis or tuberculosis
     4. Serious known allergies or earlier anaphylactic reactions.
     5. Known sensibility to Montanide ISA-51
     6. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
     7. Pregnant and breastfeeding women.
     8. Fertile women not using secure contraception with a failure rate less than \< 1%
     9. Patients taking immune suppressive medications incl. systemic corticosteroids and methotrexate at the time of enrollment
     10. Psychiatric disorders that per investigator judgment could influence compliance.
     11. Treatment with other experimental drugs
     12. Treatment with other anti-cancer drugs - except IFN-a, hydroxyurea or anagrelide.
     13. Treatment with ruxolitinib.
     14. Treatment with chemotherapy or immune therapy (excluding IFN-a, hydroxyurea or anagrelide) within the last 28 days.
Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ systems. These adaptative changes may be affected such as type of delivery and anesthesia management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's cerebral and renal oxygenation in elective cesarean operations

The cases divided into two groups those spinal anesthesia group ( group:1; n:30 ) and general anesthesia group (group:2; n:30). The preoperative and intraoperative mean arterial pressures (MAP), heart rate (HR), arterial oxyhemoglobin saturation (SpO2), intraoperative blood loss values of pregnants and 1st-5th minute APGAR scores, preductal and postductal SpO2, perfusion index, heart rates, body temperature, cerebral and renal regional oxygen saturations of newborns after birth have been recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo elective cesarean
* American Society of Anesthesiologists class 1 to 2
* Ability to consent
* Gestational age: from 37 to 41 weeks

Exclusion Criteria:

* Pulmonary disease
* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Neurologic disease
* Coagulation disorders
* newborns with anomalies
* low birth weight newborns
* newborns needing neonatal resuscitation
A Nutritional Approach to Minimal Hepatic Encephalopathy

This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* All consented adults (age \> 18), with the diagnosis of CHILD A cirrhosis with MELD score of \< 10.
* Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score \> 12 kpa) and / or fibrotest (score \> 0.74) and /or imaging.

Exclusion Criteria:

* History of \> grade II hepatic encephalopathy (HE).
* Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
* Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
* Current use of lactulose or neomycin.
* Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.
Effect of Corn Silk Tea on Hypertension

Subjects having hypertension were divided into 3 groups. one control and two experimental who were provided with 2g and 4g of corn silk tea twice per day for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

Subjects with Hypertension both male and female Subjects above age 30 years

-

Exclusion Criteria:

* Subjects below age 30 years Pregnant and Lactating women Subjects with no co morbidities
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula

The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.

This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).

Eligibility Criteria:
Inclusion Criteria:

* Age: 0 to 6 months;
* Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
* Unable to breastfeed;
* Vital signs are stable;
* Legal guardian has signed the informed consent.

Exclusion Criteria:

* Subject with congenital and hereditary metabolic diseases;
* Digestive tract obstruction;
* Subject with immunodeficiency diseases;
* Subject who is allergic to known components of amino acid formula powder;
* The investigator judges it is not suitable for the subject to participate in this study.
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
* Females must be past menopause
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
* Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion Criteria:

* Subject has a history of multiple/severe allergies to drugs or food
* Subject has donated blood within 4 weeks of starting the study
* Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
* Subject has any infections or any condition leading to immune problems, including HIV
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject drinks 4 or more caffeinated beverages per day
* Subject uses any prescription or nonprescription medications
The Effects of Virtual Reality Patients With Obstetric Brachial Plexus Injury

Obstetric brachial plexus injury is the flask paralysis of the arm, which emerges from a difficult birth. This results from the damage to the nerves from the C5 cervical root to T1. Following brachial plexus injury, movement impairment, a decrease in the joint range of motion, muscle contractures, motor disorders related to muscle weakness, and the loss of functional movements are commonly observed. Many rehabilitation programs for the upper extremity aim at developing functional improvement in addition to increasing the active range of motion of the related limb in children with Obstetric brachial plexus injury. Obstetric brachial plexus injury treatment includes both conservative and surgical interventions. The first intervention in all the Obstetric brachial plexus injury cases is conservative. In recent years, supporting the treatment with virtual reality exercises in addition to the conventional brachial plexus rehabilitation is a method being tested. The use of virtual reality treatment in physiotherapy and rehabilitation has substantially increased within the last 6-7 years. Virtual reality is a method that enables working with task-based techniques by creating stimulating and entertaining environments and especially using children's interest and motivation. Nintendo Wii, which is used in the virtual reality treatment, is a device that can be controlled wirelessly, consists of a system console, remote control for activity control, and a sensor perceiving the change in movements, and a display screen, and gives the opportunity to work with the person individually. The aim of this study is to investigate the effects of the conventional physiotherapy approach and virtual reality applications with Nintendo Wii, applied additionally in this study, on upper extremity functions in children with obstetric brachial plexus injury. They can directly be mentioned as the effects on muscle strength, normal joint range of motion, and functionality.


Eligibility Criteria:
Inclusion Criteria:

* undergone primary or -if available- secondary surgery at least 6 months before
* Being between the ages of 5-13
* be affected by the C5-C6 (upper truncus)

Exclusion Criteria:

* Patients with severe cognitive functional disorder
* Patients with cognitive functions inadequate for communication
* Patients with any neurological problems
* Patients who have a contracture preventing the upper extremity joints from performing activities
Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients

This study aims to assess the feasibility and effectiveness of laparoscopic toupet fundoplication (LTF) for treating gastroesophageal reflux disease (GERD) symptoms and disease-specific Quality of Life (QoL).

Heartburn, regurgitation, dysphagia, and chest pain are regarded as common esophageal symptoms of gastroesophageal reflux disease (GERD). On the other hand, there are very few reports of laryngopharyngeal reflux (LPR), which is associated with persistent upper airway contact, acidic and non-acidic reflux, and aerosol that results in posterior laryngitis, edema, and glottis erythema.

Proton-pump inhibitor (PPI) therapy, Laparoscopic Nissen Fundoplication (LNF), and Laparoscopic Toupet Fundoplication (LTF) have been proven to be effective for the treatment of GERD. However, the therapeutic management of patients with hiatal hernia is debated and treatment remains empirical. Previous studies on PPI therapy and LNF had been published with promising but controversial results. Therefore, the role of LTF is even less explored and evidence is scarce

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old.
* Both sexes.
* Hiatal hernia patients (Hill's grade III \& IV) by endoscopy and negative by radiology indicated for Toupet fundoplication.

Exclusion Criteria:

* Recurrent patients.
* Age above 70 years old
* Unfit for surgery
Building Stronger Allies

BSA is a novel, computerized intervention specifically designed for active military personnel with the intent to reduce two risk factors known to be associated with suicide outcomes.

The investigators have focused on the identification of malleable risk factors for preventative intervention in a number of types of psychopathology including suicidality. In the case of Perceived Burdensomeness (PB) and Thwarted Belongingness (TB), theory suggests that they may be malleable, though this has received little empirical attention. Taken together, the Interpersonal Theory of Suicide and related empirical literature suggest that targeting PB/TB should offer a novel and important avenue to reduce suicidality. This inspired the investigators' efforts to create and evaluate an intervention - called Building Stronger Allies (BSA) - designed to reduce these factors.

Eligibility Criteria:
Inclusion Criteria:

* Must show at least some suicide risk based on scoring \> 0 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Must also own a Smartphone.

Exclusion Criteria:

* No evidence of such serious suicidal risk that would indicate a need for immediate hospitalization or emergency intervention.
* No planned moves/deployments for the next 3 months.
Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients

This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.

This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients.

For both Cohort I and II, subject participation will require two visits (initial and 3-4 month follow up), which are expected to last approximately 30 minutes. Subjects will undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure. The actual EIT imaging will last for 10 to 15 minutes.

Eligibility Criteria:
Cohort I

Inclusion Criteria:

1. ALS patients able to perform PFT.
2. ALS patients recommended for PFT.
3. Subjects capable of giving written informed consent.
4. Adult, age ≥ 18 years old.

Exclusion Criteria:

1. Serious psychiatric illnesses.
2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
3. Skin lesions at chest belt placement sites.
4. Pregnant women.
5. Patients with primary lung disease, at the discretion of the Investigator.

Cohort II

1. Subjects capable of giving written informed consent; 2. Subjects capable of performing a PFT; 3. Adult, age ≥ 18 years old 10.2.2 Exclusion Criteria

1. Serious psychiatric illnesses.
2. Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
3. Skin lesions at chest belt placement sites.
4. Pregnant women.
5. Subjects with primary lung disease, at the discretion of the Investigator.