cyrilzakka/clinical-trials huggingface dataset:
AminoMedixTM for Kidney Protection During Radionuclide Therapy

This is a phase I, and II, single-center, open-label clinical trial to evaluate the safety and preliminary efficacy information of AminoMedix™ in protecting kidneys from radiation-induced toxicity during Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.

Aims of the study:

1. Evaluation of the safety of AminoMedix ™ infusion.
2. Evaluation of kidney radiation dosimetry with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE.
3. Evaluation of the safety and calculation of kidney and tumor radiation dosimetry after AminoMedix™ infusion with low dose 177Lu-DOTATATE in patients with neuroendocrine cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with neuroendocrine tumors are eligible to be recruited in this project.
2. Signed informed consent.
3. Patients of either gender, age 18 years or older.
4. Na+, K+, Cl,: within normal range
5. eGFR: \> 50 mL/min
6. Serum creatinine: \<150μmol/L. Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older.
7. Negative pregnancy test (urine test or beta-HCG) in women capable of child-bearing.

Exclusion Criteria:

1. Known hypersensitivity to Amifostine, Lysine, Arginine, DOTA, 68Gallium, to DOTATATE or to any of the excipients of 68Ga-DOTATATE.
2. Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
3. Pregnant or breast-feeding women.
4. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
5. Pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks.
6. Uncontrolled kidney disease and patients who are under dialysis.
7. Current treatment with potentially nephrotoxic drugs such as aminoglycosides.
8. Less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study.
9. Patients under total or partial parenteral nutrition.
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex .

FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.

Eligibility Criteria:
Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible.

In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P \< 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

Eligibility Criteria:
Inclusion Criteria:

* Consenting women aged 20y-70y with HPV-positive results

Exclusion Criteria:

* Not providing informed consent
* previously confirmed CIN, cervical cancer, or other malignancies
* previous therapeutic procedure to cervix
* pregnancy
Exercises in the Post-operative Rehabilitation of THA

Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.

Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.

Eligibility Criteria:
Inclusion Criteria:

* Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
* Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
* Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.

Exclusion Criteria:

* Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
* previous surgical procedures in the coxofemoral joint;
* surgical procedures and osteoarticular diseases in the lumbar spine;
* osteoarticular diseases in lower limb joints;
* muscle injuries in lower limbs;
* presence of signs or symptoms of osteoarthritis in the contralateral hip;
* postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
* intra-articular injection of corticosteroids in the lower limbs during the last six months;
* cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
* presence of neurological diseases.
Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy

The incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. In Cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. Spasticity is defined as a velocity dependent resistance to stretch. Spastic Cerebral palsy is caused by damage to the pyramidal parts of the brain.

The children with spastic CP frequently experience problems with motor control, and balance which may lead to gait abnormalities. Because of motor weakness and poor voluntary motor control the children with spastic cerebral palsy develop crouch gait characterized by excessive hip and knee flexion and a slower walking speed, a shorter stride length, and more time spent in double support. This study will help in the quality of life in spastic cerebral palsy children. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 Children with Spastic CP will be randomly distributed into 2 groups. The Control Group (n=10) will be administered with the baseline treatment that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation 3 sessions per week for 8 weeks. The experimental group (n=10) will be administered with the strength training intervention along with baseline treatment, 3 sessions per week for 8 weeks. Gait parameters will be evaluated physically by measuring stride and step length and cadence.

5-meter stretch test for gait parameters. the energy expenditure will be calculated by measuring the physiological cost index that includes measuring the speed of walking and resulting increase in heart rate. Data will be analyzed by using SPSS version 26.0 and necessary analysis will be done after checking the normality of Data.


Eligibility Criteria:
Inclusion Criteria:

* Diplegic Cerebral palsy
* (GMFC) level 1 and 2
* Able to follow verbal direction for standard testing

Exclusion Criteria:

* Orthopedic and Neurosurgery in last 12 months
* Children with any associated medical condition
* Children with Botox therapy in last six months
Metabolic Availability of Lysine From Millet in Adult Men

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.

As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.

Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.

4 reference diet would be based on egg protein composition, 3 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet and lentils.

Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.

For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.

Measurements:

Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry Body composition (fat and fat free mass) will be measured by BIA and Skin Fold. Breath samples will be collected after the 4th and 7th meals.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 18 - 49 yrs Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes Stable Body Weight Not on any medications that could affect protein or amino acid metabolism e.g. steroids

Exclusion Criteria:

* Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients)
Metabolic Syndrome and Male Infertility

Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

Assessment of sperm parameters and metabolic syndrome relations in men attending a Reproductive Biomedicine centre for an infertility of their couple.

Secondary objectives are to study relationship between sperm parameters and:

* adiposity and insulin resistance
* inflammation
* oxydative stress in blood and semen
* hormonal status Innovative parameters will also be assessed to determine the quality of semen (length of fingers, wrist circumference and epigenetics studies)

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years-old man
* man consulting for primary or secondary infertility, with or without earlier notion of paternity
* patient insured with a social security scheme
* patient who have had a prior medical consultation
* patient who have done informed and written consent to participate in the research study

Exclusion Criteria:

* patient with problems understanding French
* patient smoking more than two-pack-a-day
* patient monitoring for viral risk.
* man with an unidiopathic infertility which may be explained by:

  1) identifiable factors in direct questioning at the sperm analysis:
* exposure to toxic products
* infectious disease history
* pathological anatomical background 2) factors identified at the etiologic investigation: cytogenetic and genetic
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients

Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients

Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 \& consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
* Age 18-80 years (patients \>70 years old: FIT according to VGM evaluation).
* aaIPI=1 +/- bulky and aaIPI=0 with bulky (\>7.5 cm)
* ECOG-PS \< 3 unless due to lymphoma
* Ventricular ejection fraction ≥ 50%
* Pulmonary, renal and hepatic tests within normal range
* Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
* Written informed consent
* Life-expectancy \> 3 months

Main Exclusion Criteria:

* T-cell lymphoma
* Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma
* PS\> 3 (if not due to lymphoma)
* Age-adjusted IPI = 0 in the absence of bulky disease
* Age\> 80 and \<18 years (see inclusion criteria)
* HIV positivity
* significant cardiopathy
Comprehensive Assessment of Risks for Miscarriage.

This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion

To study the added value (if any) of combining serum markers, immunologic factors, and ultrasound parameters in comprehensively evaluating the risk for spontaneous abortion.

Eligibility Criteria:
Inclusion Criteria:

* visualized fetal structures in utero \& heart pulsations until 8th week of gestation
* normal THS/T4 levels
* no uterine malformations
* BMI \< 27
* signed informed consent

Exclusion Criteria:

* fetal structures in utero \& heart pulsations not visualized until the 8th week of gestation
* elevated THS/T4 levels
* uterine malformations
* BMI \> 27
Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy

The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.

In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and 65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of lower limbs during gait.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 1 or 2 diagnosed for at least seven years
* body mass index ranging 18.5-29.9 kg/m2 (normal and overweight classifications)
* diabetic polyneuropathy diagnosed by the medical care center: score higher than 2 out of 13 in the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, indicating the presence of at least two diabetic polyneuropathy symptoms; score higher than 1 out of 10 for physical assessment of the MNSI instrument, but always including impaired vibration perception
* ability to walk independently in the laboratory

Exclusion Criteria:

* ulceration not healed for at least 6 months
* partial or total foot amputation
* receiving any physiotherapy intervention or offloading devices
* neurological or orthopedic impairments
* major vascular complications
* severe retinopathy
* severe nephropathy
Intensive Therapy of Shoulder External Rotators in Erb's Palsy

Erb's palsy is a common neurological injury occurs at the time of birth. It causes injury to the upper trunk nerve root c5-c6, i.e., supply is around shoulder and muscles of forearm and these nerves network from the spine and pass through the cervicoaxillary canal in the neck and the ribs and emerge into the axilla. Restoring external rotation in erb's palsy is quite difficult and mostly surgery is recommended but if physiotherapy sessions are given with extended time up to 2 hours and latest techniques are applied to strengthen external rotators then range of external rotation can be improved.

Erb's palsy is form of brachial plexus palsy which involves injury to cervical nerve roots c5 c6 causing loss of movements and deformities i.e., internally rotated shoulder, hanging arm and waiter's tip hand deformity. Most common risk factors are shoulder dystocia, maternal obesity, breech presentation and high birth weight of child. Its incidence is 0.42 per 1000 live births in which 25% experience permanent impairment and injury.

Both Conservative and non-conservative treatment protocols are applied in erb's palsy but key interventions are positioning in early infancy, passive range of motions and gentle stretching. Another latest treatment approach is intensive physical therapy in which single session duration is extended to three to four hours with combination of treatments. This study will be randomized control trial, used to check effectiveness of intensive physical therapy to restore shoulder external rotation in erb's palsy. Subjects with erb's palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups by using lottery method. Pre assessment will be done by using AROM on goniometer as objective measurement. Subject in one group will be treated with intensive physical therapy and the other with conventional treatment. Each subject will receive 5 Treatment sessions per week for 6 months.

Recorded values will be analyzed by using SPSS version 25

Eligibility Criteria:
Inclusion Criteria:

* Children (male and female)
* Ages ranged from 9 months to 12 months
* Unilateral involvement of c5, c6 and c7
* patients did not undergo surgery of the nerves or plexus

Exclusion Criteria:

* Musculoskeletal or neuro-muscular abnormalities other than Erb's palsy
* Contractures or fixed limitations in the affected upper extremity
* Hypersensitivity to latex and adhesive tapes