cyrilzakka/clinical-trials huggingface dataset:
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).

Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.


Eligibility Criteria:
Inclusion Criteria:

* Pre-pubertal children, boys:

  1. age between 2.5 and 11.0 years at screening.
  2. testes volume below 4 ml.
* Pre-pubertal children, girls:

  1. age between 2.5 and 10.0 years at screening.
  2. Tanner stage 1 for breast development (no palpable glandular breast tissue).
* Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
* Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
* Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
* No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

Exclusion Criteria:

* Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
* Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
* Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
* Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening.
* Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder.
* Diagnosis of attention deficit hyperactivity disorder.
* Prior history or presence of malignancy including intracranial tumours.
Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults

This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Ages 18-40
* Negative for H. pylori infection
* Contraception for females

Exclusion Criteria:

* Present or past H. pylori infection
* Medically significant gastroduodenal disease
* Recent corticosteroid use
* Bleed diathesis
* Use of antibiotics used to treat H. pylori infection
Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study

The aims of this clinical pilot study are to:

1. to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure
2. to evaluate the feasibility on detecting fetal movements
3. to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
4. to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring

The participating pregnant women will wear the pregnancy monitoring belt for 2 hours during of which, the data will be collected with pregnancy monitoring belt and patient monitor (reference device). The data from the pregnancy monitoring belt will be compared with the patient monitor data referred as golden standard. The acceptability and usability will be assessed by pregnant women and healthcare professionals by fulfilling a questionnaire and participating in interviews. The data collection will be conducted in hospital environment.


Eligibility Criteria:
Inclusion criteria for pregnant women:

* duration pf pregnancy at least 29+0 weeks
* single pregnancy
* age at least 18 years
* ability to participate in Finnish No exclusion criteria

Inclusion criteria for healthcare professionals:

* being a healthcare professional working with pregnant women
* being able to participate in Finnish No exclusion criteria
Immediate Effect of Dry Needling on Trigger Points

The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on their viscoelastic properties (tone, elasticity and stiffness)

Objectives: To investigate the immediate effects of a dry needling puncture on the viscoelastic properties (tone, stiffness and elasticity) of a trigger point (TP) located in the infraspinatus muscle in participants with non-traumatic chronic shoulder pain.

Methods: Forty-eight individuals who presented non-traumatic chronic shoulder pain were recruited. The presence of a TP in the infraspinatus muscle of the painful side was confirmed by an experienced physiotherapist with a palpatory exam according to Travell and Simons criteria. The TP was marked and the viscoelastic properties including tone, stiffness and elasticity were measured with the MyotonPro device by an evaluator. After the first set of measurements (T1), an experienced physiotherapist applied a dry needling puncture to the TP with a pistoning technique to obtain a local twitch response (LTR) with an Optimed 40 x 0.30 mm single use acupuncture needle. The same set of measurements was repeated immediately after the dry needling (T2) and 30 minutes later (T3). Repeated measures ANOVA and post-hoc tests were used to assess changes in viscoelastic properties over time with a significant level set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. present with chronic shoulder pain of non-traumatic origin (rated at least 2/10 on a numeric rating scale (NRS) for more than 3 months. The pain had to be located in the shoulder area or referred in the area of the infraspinatus as described by Travell and Simons (1999);
2. have a hyperirritable spot within a palpable tight band that reproduced the participant's pain when compressed by palpation; and
3. have a body mass index (BMI) lower than 28

Exclusion Criteria:

1. diagnosis of capsulitis, cancer, or metastasis;
2. previous shoulder or thorax surgery or a mastectomy;
3. shoulder girdle bone fracture;
4. C4-C5 or C6 radiculopathy;
5. known osteoporotic profile (positive bone densitometry);
6. apparent atrophy of the infraspinatus fossa (visual interpretation) and
7. contraindications to receive a DN intervention
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
* 20 years or older
* Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
* Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
* Patients who voluntarily decided to participate in this clinical study and signed a written informed consent

Exclusion Criteria:

* History of previous abdominal irradiation.
* When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
* Distant metastasis
* Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn

Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn

This study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units.

This is a randomized controlled experimental study. The sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. Study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). Environmental variables were kept the same for both groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort Behavior Scale (NCBS).

Eligibility Criteria:
Inclusion Criteria:

* Being a newborn born at the 37th gestational week and above,
* Completing 24 hours following the birth
* Having a stable condition (no tachycardia and bradycardia)

Exclusion Criteria:

* Having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as Hood and CPAP)
* Having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃)
* Having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial USG.
Effect of Untact Upper Extremity Rehabilitation Using a Smart Board for Late Subacute and Chronic Patients with Brain Disorder

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Board by comparing the effects between a group using the home-based Neofect Smart Board and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with neurological diseases aged 19 to 85 years old
* Patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function
* Patients with shoulder flexor and adductor muscle strength of MRC grade 2 or higher
* Patients with shoulder extensor and abductor spasticity of MAS grade 1+ or lower
* Participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, and to perform the tasks (K-MMSE ≥21)

Exclusion Criteria:

* pre-existing significant neurogenic disorders
* major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
* History of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation
* Severe spasticity of the affected upper limb (Modified Ashworth Scale score ≥3)
* skin disorders or open wounds on the affected upper limb
* Amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb
* severe pain that interferes with rehabilitation of the affected upper limb (Numeric Rating Scale \> 6)
* Inability to maintain a seated posture for more than 10 minutes, which is required for using the smart board
* Significant visual impairment to the extent that the screen cannot be recognized when using the smart board
Pertussis Immunization During Pregnancy & HIV Infection

The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.

Despite the growing importance of maternal immunization in the control of infectious pathogens in early life, the impact of pregnancy on vaccine immunogenicity remains poorly understood. Evidence suggests that pregnancy may influence the quality of the antibody response to vaccines. Pregnancy is associated with modifications in the glycosylation profile of immunoglobulins G (IgG). Different patterns of glycosylation are associated with differential regulation of the effector functions of IgG such as antibody-dependent cell cytotoxicity, complement activation or antibody dependent phagocytosis. Whether similar modifications affect vaccine-induced IgG in pregnant women is unknown.

HIV infection is associated with important alterations in B cells and antibodies. Although antiretroviral therapy partly corrects the proportions of memory B cells (MBC) subsets, it does not restore B cell responses to vaccines, measured as seroconversion rates and antibody persistence. Reduced IgG responses to vaccines have been observed in HIV-infected pregnant women but the impact of HIV on the quality of vaccine-induced IgG has not been reported. On the other hand, HIV infection in pregnancy has a strong impact on the transfer of maternal IgG to the newborn, possibly as a consequence of hypergammaglobulinemia and immune activation.

The investigators will:

1. Assess the respective impact of pregnancy and HIV infection on the magnitude and quality of B cell and antibody responses to pertussis immunization with the TDaP vaccine.
2. Assess the impact of HIV infection and of the timing of maternal immunization on the transplacental transfer and on the quality of pertussis-specific IgG in the newborn.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* HIV-infected or uninfected pregnant women in their second/third trimester with an indication of TDaP vaccination
* Non pregnant HIV negative women (having a negative HIV test in the last 6 months or at screening) with an indication of TDaP vaccination

Exclusion Criteria:

* Grade III/IV anemia
* Active bacterial infection
* Opportunistic infection (Tuberculosis, CMV, toxoplasmosis, etc)
* Inability to understand the nature and extent of the study and the procedures required
* Current or recent use of immunosuppressive drugs (corticosteroids, anti-TNF, methotrexate, etc)
* Active neoplasia
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male (18 -70 yrs)
2. Body weight must be ≥ 50 kg and \< 120 kg, with a body mass index (BMI) \>18 but \< 35.
3. Laboratory parameters values within the normal range

Exclusion Criteria:

1. Contraindication or hypersensitivity to receiving nilotinib
2. Smokers or those who use of tobacco products or products containing nicotine
3. A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
4. History of fainting spells.

Other protocol-defined inclusion/exclusion criteria may apply.
imprOving Adherence to Pulmonary artErial hyperteNsion Treatment With teLemedicIne and patieNt guidaNce - A Randomized Multicenter Study

Pulmonary arterial hypertension (PAH) is a progressive condition with high morbidity, frequent hospitalizations, and risk of right heart failure. Despite advances in treatment, poor adherence remains a major challenge. This randomized controlled study assesses whether remote monitoring can improve treatment adherence, clinical outcomes, and side effect management in PAH patients on oral therapy.

Pulmonary arterial hypertension (PAH) is a severe, progressive condition requiring strict adherence to complex treatment regimens to improve outcomes. Despite advances in pharmacological therapy, non-adherence remains a significant challenge, impacting disease progression and increasing healthcare burden.

The OPENLINE study is a randomized, multicenter clinical trial designed to evaluate the impact of a structured telemedicine intervention on treatment adherence in PAH patients receiving stable oral therapy. Participants in the intervention group will receive biweekly teleconsultations for six months, focusing on patient education, adherence monitoring, and side effect management. The control group will follow standard clinical care without additional remote support.

The primary outcome is medication adherence, assessed using the Martín-Bayarre-Grau (MBG) scale. Secondary outcomes include changes in functional class, six-minute walk test distance, brain natriuretic peptide (BNP) levels, risk stratification (COMPERA 2.0 and REVEAL Lite), hospitalizations, mortality, and quality of life measured by the CAMPHOR questionnaire.

This study aims to determine whether a telemedicine-based intervention can enhance medication adherence and improve clinical outcomes in PAH patients, potentially informing future care strategies.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years diagnosed with pulmonary arterial hypertension (PAH) (Group 1 of the WHO classification).
* Stable oral PAH therapy (including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin pathway agents) for at least four weeks prior to enrollment.
* Ability to participate in remote teleconsultations (access to a phone or internet).
* Signed informed consent agreeing to study participation.

Exclusion Criteria:

* Severe cognitive impairment or psychiatric disorders that could affect adherence or study participation.
* Inability to communicate via phone or telemedicine due to technical or personal constraints.
* Concurrent participation in another interventional clinical trial that could interfere with outcomes.
* Life expectancy \<6 months due to any condition unrelated to PAH.
* Pregnancy or breastfeeding.
Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body contour,decrease fat localized and appearance of gynoid lipodystrophy.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.

HYPOTHESES: It is expected that the patients will present improvement in the body contour, decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p \<0.05.

After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be personal data, anthropometrics and complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started treatment with another physiotherapist who will perform the following study protocol: placing a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens, buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks, posterior thigh emil shots in the region of flanks. The protocol will be performed twice a week for 1 and 20 hours each, totaling 10 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years of age up to premenopausal age (50 years of age).
* With body mass index considered eutrophic and / or overweight.
* Patients with lipodystrophy and localized abdominal fat.
* non smokers.
* Who agree to participate and sign the informed consent form.

Exclusion Criteria:

* Male gender.
* Possible.
* Haemophilia carriers and hemorrhagic disorders.
* Carriers diabetes mellitus.
* Women in menopause.
* Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last 1 months.
* Patients with skin lesions, such as dermatitis and dermatoses.
* Patients with acute deep vein thrombosis (DVT).
* About or close to cancerous lesions.
* Patients with cardiac pacemaker or other implanted electronic device.