cyrilzakka/clinical-trials huggingface dataset:
Lumbar Intervertebral Motion in Asymptomatic Male Participants

The investigators aim to analyze the physiological segmental motion of the lumbar spine during flexion and extension cinematographic recordings of asymptomatic individuals.

In this study the investigators aim to define the lumbar spines' physiological motion by analyzing sequence of initiation of motion and sequence of maximum contribution in segmental translation and rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. Participants will undergo two cinematographic recordings with an interval of two weeks. Segmental translation and rotation of each segment will be plotted against total range of motion of the lumbar spine for each individual participant. With these graphs the investigators can analyze if there are specific physiological motion patterns during flexion and extension of the lumbar spine. In the future, the investigators hope to compare these physiological motion patterns to potential abnormal motion patterns in patients suffering from lumbar spinal pathology or after lumbar spine surgery to gain knowledge about complaints and, for example, adjacent level disease.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 25 years old.
* BMI under 25
* Participants have to be able to perform flexion and extension over a full range of motion without complaints of pain.
* Participants have no medical history of spinal problems based on anamneses and zero ODI-, and VAS-score.
* Kellgrens' classification on cinematographic recordings is zero or one.
* Informed consent has been signed.
* Ability to read and understand Dutch.

Exclusion Criteria:

* Medical history of visiting general practitioners, allied health professionals or specialists for spinal problems.
* Former spine surgery.
* Radiographs of abdomen, pelvis, hips, lumbar spine or sacral spine in last year.
* Degenerative abnormalities of the lumbar spine.
* Active spinal infection.
* Immature bone.
* Lumbar tumor processes.
* Former lumbar radiotherapy.
* Congenital lumbar spine abnormalities, for example spina bifida.
* Planning pregnancy for the coming year.
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.

Objectives:

* To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment.
* To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed squamous cell carcinoma
* Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)
* Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)
* Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician
* Metastatic disease is permitted

Exclusion Criteria:

* Contraindications to radiotherapy
* Pregnant or lactating women

5.0 PRE-TREATMENT EVALUATION

* History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.

  o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
* Documentation of smoking history
* Staging imaging within 12 weeks prior to randomization:

  * Contrast-enhanced CT of the neck and chest or
  * MRI of the neck with CT of the chest or
  * Whole body PET/CT
* Histological confirmation of squamous cell carcinoma
* Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
* Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
* Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
* Completion of QOL scoring within 2 weeks of randomization
* Informed consents must be obtained prior to any study specific activities
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women

Shatavari is a plant that grows in Nepal, Sri Lanka, India and the Himalayas and its root has long been used in Ayurvedic medicine. Its traditional uses include supporting women's health, particularly during breastfeeding and during the perimenopausal period. Shatavari has been found to contain substances that have similar chemical properties to estrogen. A decrease in the amount of ovarian estrogen production causes the menopause and this reduction in circulating estrogen has widespread effects, including promoting a decrease in bone density. This increases the risk of bone fractures. Having less oestrogen is also thought to contribute to a loss of muscle strength in postmenopausal women.

As shatavari may act on the body's tissues in a similar way to estrogen, shatavari supplementation may represent one way of preventing postmenopausal bone and muscle loss. This study will investigate these questions. 24 healthy postmenopausal women aged 60 years or older will be recruited. The participants will be randomly assigned to consume shatavari (1000 mg per day, equivalent to 26,500 mg per day fresh weight shatavari) or placebo (1000 mg per day magnesium stearate) for 6 weeks. Handgrip and knee extensor strength will be measured at baseline and at 6 weeks. Vastus lateralis (VL) muscle biopsy samples will be obtained at baseline and at 6 weeks and analysed for markers of muscle function and protein turnover. Plasma and serum samples will be collected via venepuncture and markers of bone turnover (P1NP, β-CTX) will be measured at baseline and at 6 weeks. Primary human osteoblasts (not obtained from these participants) will be stimulated with pooled sera from the placebo and shatavari supplementation conditions to assess markers of osteoblast (bone-building) activity.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (Last menstrual period \> 12 months ago)
* Aged 60 years or older

Exclusion Criteria:

* BMI ≥ 30
* Diagnosis (DEXA t-score \< -2.5) and/or treatment for the prevention of osteoporosis, including treatmeat with bisphosphonates and non-bisphosphonates (including, but not limited to raloxifene, denosumab, teriparatide, calcitriol and estrogenic hormone replacement therapy).
* Currently taking estrogenic hormone replacement therapy or history of estrogenic hormone replacement therapy in the past 5 years via any route of administration apart from vaginal.
* PAR-Q+ screening indicates physical activity is unsuitable.
A Cross-Sectional Study of Serum Levels of Adipocytokines in Children With Febrile Seizures

Febrile seizure (FS) is a common neurological condition in children, affecting 2 - 14% of children. FS is defined as seizures occurring in a child aged from six months to five years that is accompanied by a fever (≥38°C) without central nervous system infection. FS is classified into simple febrile seizure (SFS) and complex febrile seizure (CFS). SFS accounts for 70-75% of FS cases and is characterized by being generalized, duration of less than 15 minutes, occurs once in 24 hours, and no previous neurologic problems. We aim to investigate serum levels of adipocytokines, specifically leptin, adiponectin, and IL-6, in children with FS.

The study will include three groups of children (100 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). Children included in this study will undergo:

* Thorough medical history taking: including age, gender, and seizure details for children with febrile seizures (e.g., type, duration, recurrence).
* Physical examination: including vital signs (particularly temperature) and comprehensive neurological examination).
* Laboratory investigations:

  * Routine investigations: complete blood count, C-reactive protein, blood glucose, serum electrolytes (sodium, potassium, calcium, and magnesium), liver and kidney function tests.
  * Serum leptin and adiponectin: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin and adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* Age from 6 months to 6 years.
* Seizures.
* Fever (≥38°C) due to acute infection.
* Presented for routine check-up.

Exclusion Criteria:

* Central nervous system infection.
* Epilepsy.
* Previous neurological abnormalities.
* Inborn errors of metabolism.
* Immunological diseases.
* Endocrinal diseases (e.g., diabetes mellitus).
* Obesity.
* Eating disorders.
* Gastrointestinal disorders (e.g., diarrhea).
* Seizures.
* Previous neurological abnormalities
* Any illness in the last month
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).

This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2 followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and 5.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high-risk neuroblastoma
* 8 years of age or younger at diagnosis of high-risk neuroblastoma
* Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy

  \* Radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor
* Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:

  \* No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
* Patient who have no tumor seen on the prior bone marrow, and then have ≤ 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible
* No more than 12 months from starting the first induction chemotherapy after diagnosis to the date of ASCT

  \* For patients who became high-risk neuroblastoma after initial non-high risk disease, the 12 months period should start from the date of induction therapy for high-risk neuroblastoma to the date of ASCT
* No progressive disease at time of registration except for protocol-specified bone marrow response
* Adequate hematological, renal, hepatic, pulmonary and cardiac function
* CNS toxicity \< Grade 2

Exclusion Criteria:

* Prior anti-GD2 antibody therapy
* Prior vaccine therapy for neuroblastoma
* Concurrent anti-cancer or immunosuppressive therapy
Staccato Apomorphine Single and Multi Dose PK

This study will be conducted in 3 parts. A) compare the pharmacokinetics (PK) of a single dose of AZ-009 with that of a therapeutically-relevant dose of a commercially available apomorphine injector in healthy volunteers; B) ascending doses of active drug in healthy volunteers; and C) examine the tolerability, safety, and PK of AZ-009 in subjects with established Parkinson's disease.

This study will be conducted in 3 parts. Parts A and B will be conducted in healthy volunteers and Part C will be conducted in subjects with established Parkinson's disease. The primary objectives for each part are as follows.

Part A: To compare the pharmacokinetics of a single low dose of AZ-009 with that of a therapeutically-relevant dose a commercially available apomorphine injector in healthy volunteers.

Part B: To examine the tolerability and safety of AZ-009 of single ascending doses of active drug in healthy volunteers while; and to characterize the pharmacokinetics of single ascending doses of AZ-009 in healthy volunteers

Part C: To examine the tolerability, safety, and pharmacokinetics of AZ-009 in subjects with established Parkinson's disease and to identify optimal doses to bring into multiple ascending dose safety and efficacy studies; and to assess the usability of AZ-009 in subjects with Parkinson's Disease

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
* Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2.
* Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

* Any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.
* History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss surgical procedure; or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial.
* Use of non-prescription medications within 5 days prior to the first dose of study drug.
* Use of medication that is inhibitor or inducer of CYP450-3A4/5 within 3 days of dosing.
* Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 3 days prior to administration of study drug.
The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol.

The main questions it aims to answer are:

* To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate.
* To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic.

The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (\<25 d or \>35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.


Eligibility Criteria:
Inclusion Criteria:

Women \<40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.

Exclusion Criteria:

1. Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
2. patients who underwent pre-implantation genetic diagnosis (PGT);
3. patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
4. patients with a Body mass index (BMI, = weight/height2 ) \> 30 kg/m2;
5. patients with recurrent spontaneous abortions;
6. patients with sequential embryo transfer.
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet

Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling high degrees of foot pronation. It is essential to administer patients foot orthoses with different inverted angles, with higher angles prescribed when greater reduction of foot pronation is indicated. However, there is shortage of clinical knowledge regarding the inverted angle in terms of biomechanical changes. The aim of this study is to investigate the effect of different inverted angles of foot orthoses on the walking kinematics in females with flexible flatfeet.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Within the age group of 18-35 years
* Asymptomatic flexible flatfeet
* Resting Calcaneal Stance Position angle of ≥ 4° in valgus in both feet (bilateral)

Exclusion Criteria:

* Previous surgery of the lower limbs or spine that might affect the performance of the study procedures
* Any severe medical or musculoskeletal conditions that may have affected the lower limbs
* Fixed flatfoot deformity
* Leg length discrepancy (\> 1cm)
* Pregnancy
Bronkow Program and Lumbar Stabilization Exercises in Chronic Non Specific Low Back Pain

The aim of this study is to compare the effects of brunkow exercise program and lumbar stabilization exercises on pain, range of motion and disability in patients with chronic non- specific low back pain

The majority of research studies have primarily focused on lumbar stabilization exercises used as a standard treatment with mobilization. To the best of our knowledge it has shown that lumbar stabilization exercises alone are less efficient than lumbar stabilization exercises in strengthening muscular strength and decreasing pain in female patients with persistent low back pain than lumbar stabilization exercises combined with pain neuroscience education. However, more extensive research on a range of educational and activity programs was required. Stabilization exercises with other modalities, manual techniques, mobilizations, or exercise therapy have been practiced in the treatment of chronic non specific low back pain were found effective individually, but there was a lack of comprehensive studies including randomized clinical trials directly comparing the brunkow exercises program with stabilization exercises in patients with chronic non- specific low back pain.

This study investigates and adds up an effective and evolutionary treatment protocol in the world of physical therapy for the management of chronic non-specific low back pain rather than other conventional therapy providing to the patients with chronic low back pain now a days.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 45 years
* Both male and female
* Low back pain \> 6 months
* NPRS\>3
* The symptoms of pain are lessened or disappeared after bed rest, while pain symptoms are aggravated after bending over, sitting for a long time, or standing for a long time.

Exclusion Criteria:

* Pelvic bone fracture
* Pregnancy
* Pelvic implants
* Lumbosacral disc herniation
* Sacroiliac joint inflammation
* Lumbar spine fracture
* Inflammatory bowel disease
* Malignancy
* Ankylosing spondylitis
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Free and complete trisomy 21
* aged between 8 and 36 years
* biological or clinical signs of auto-immune disorder (group 1)
* no sign of auto-immune disorder (group 2)

Exclusion Criteria:

* any antimitotic or immune depressing treatment during the last 6 months
* Current infectious disease
* Corticosteroid therapy in the last 3 weeks
* pregnancy
Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

This is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 65 years and older
* Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only

Exclusion Criteria:

* Off-pump or any other procedure in addition to CABG
* Emergent procedure
* One-lung ventilation
* Non-English speaking
* Baseline tMoCA score \<10
* Preoperative inotrope use
* Preoperative vasopressor use
* Intra-aortic balloon counterpulsation
* Mechanical circulatory support (Intra-aortic balloon pump (IABP)/ Ventricular assisted devices (VAD)/Extracorporeal membrane oxygenation (ECMO))
* Active cardiac ischemia
* Acute decompensated arrhythmia
* O2 sat \< 90% on supplemental oxygen
* Use of continuous vasopressor or inotrope infusion medications
* Significant physician or nurse concern

Cessation Criteria

* Development of significant intraoperative hemodynamic compromise as a result of cardiac surgery
* Oxygen desaturation \<90% for \> 3 min
* Significant physician or nurse concern