cyrilzakka/clinical-trials huggingface dataset:
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)

It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).

Eligibility Criteria:
Inclusion Criteria:

* have a cesarean section necessity
* be over 18 years old
* being younger than 40

Exclusion Criteria:

* emergency cesarean section
* Being under 37 weeks pregnant
* multiple pregnancies
* having had uterine surgery
* uterine malformations
Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points

The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points.

The purpose of this pilot study is to explore the usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points. The study will consist of a 2-week, open-label treatment period followed by a 2 week follow-up period conducted at a single study site. Eligible patients must have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 identifiable myofascial trigger points. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 myofascial trigger points
* have trigger points confined to the upper back, shoulder, and neck

Exclusion Criteria:

* have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
* have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
* have used any injected pain medication with 28 days preceding the Screening/Baseline Visit
* are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.
A Phase II Clinical Study of the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)

To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).


Eligibility Criteria:
Inclusion Criteria:

1. Meet the body mass index standard among 18.0 to 30 kg/m2;；
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 12 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.

Exclusion Criteria:

1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
2. With autoimmune disease;
3. With poorly-controlled diabetes, thyroid disease requiring clinical intervention, clinically significant thyroid dysfunction, neurological or psychiatric disorder, severe lung disease, chronic renal disease or retinopathy;
4. History of solid organ transplantation or hematopoietic stem cell transplantation;
5. Poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
6. Malignant tumors were diagnosed within 5 years prior to randomization；
7. Infection requiring intervention within 4 weeks prior to randomization;
8. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
9. Laboratory tests during the screening period were obviously abnormal;
10. Prolonged ECG QTc interval (male \> 450ms, female \> 470ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
11. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
12. Participated in clinical study of other drugs (received experimental drugs);
13. Pregnant or nursing women;
14. Allergic to a drug ingredient or component;
15. Other reasons for ineligibility as judged by the investigators.
Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease

Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks studies there is a need to follow-up on long term safety and efficacy of any maintenance iron therapy.

This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside 1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).


Eligibility Criteria:
Inclusion Criteria:

1. Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
2. Life expectancy beyond 18 months by Investigator's judgement.
3. Willingness to participate after informed consent. -

Exclusion Criteria:

1. Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
2. Any major protocol deviation in Lead-in Study.
3. Pregnancy and nursing \[To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches\].
4. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
5. Patients with a Harvey-Bradshaw Index \>8 or Partial Mayo Score (excluding Endoscopy Sub-score) \>6 at End of Study Visit of Lead-in Study.

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Pressure Injury Prevention in AE and PFC

This study evaluates the effect of a multilayer skin dressing (Mepilex) placed on the sacrum or a fluid filled pad (LiquiCell) on risk factors for pressure injuries under conditions consistent with military long-distance transport or prolonged field care. Participants will be assigned to one of six groups - air transport, air transport on a spinal immobilization surface with or without Mepilex or on a field stretcher with or without LiquiCell.

Combat casualties undergoing long distance aeromedical evacuation (AE), particularly casualties who are immobilized because of possible spine injuries, and casualties who required prolonged field care are at increased risk for pressure injuries. The risk factors pressure and shear are potentially modifiable via solutions appropriate for these austere conditions. Two interventions (Mepilex and LiquiCell) will be evaluated under conditions simulating military medical transport on a standard stretcher or with spinal immobilization in a vacuum spine board (VSB) or on a military stretcher used under field conditions. Mepilex is a multi-layer dressing that can be placed on the skin (sacrum/buttocks) and LiquiCell is a pad filled with pockets of fluid that is placed under the back and buttocks. The effect of these interventions compared to not using them will be studied under the three conditions with or without the intervention (Mepilex or LiquiCell) using measures obtained on the lower back/sacrum including skin interface pressure, oxygen, moisture, and temperature and a cytokine indicating possible tissue damage.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18 to 55
* Meet the physical standards for military personnel
* Weigh less than 250 pounds
* Be able to remain in the study position for the duration of the study.

Exclusion Criteria

* Previous injuries to sacrum/buttocks with scarring
* History of pressure injuries
* Cardiovascular disease
* Neurological disease that would affect vascular response
* Diabetes
* History of malignancy
* Current skin condition (e.g., eczema or psoriasis)
* Current neck/back pain or history of chronic neck/back pain
* Known vertebral/spinal cord disease/injury (scoliosis, kyphosis, or lordosis)
* Self-reported pregnancy
* Concern about ability to remain in the vacuum spine board for 120 minutes
Pharmacokinetic Evaluation of Testosterone Gel (1%)

Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

* Clinically significant uncontrolled medical condition or psychiatric disorder
Knowledge, Beliefs and Attitudes of Greek Physiotherapists About Communication With Chronic Musculoskeletal Patients

The purpose of current research study is to assess physiotherapists's knowledge, beliefs and attitudes about empathy, motivational interviewing and shared decision making in chronic musculoskeletal patients. An e-survey study will be conducted based on Checklist for Reporting Results of 52 Internet E-Surveys (CHERRIES)

The main questions it aims to answer are:

What physiotherapists know about the use of empathy, motivational interviewing and shared decision making? What beliefs do physiotherapists have about the appropriate use of communication skills? Whether and how much they use empathy, motivational interview, shared decision-making in clinical practice? What are the main barriers of using communication skills (empathy, motivational interview, joint decision-making) in clinical practice?

Eligibility Criteria:
Inclusion Criteria:

* Physiotherapists who are member of Panhellenic Association of Physiotherapist in Greece, with active clinical practice in Greece and clinical experience in musculoskeletal disorders (\>12 months).

Exclusion Criteria:

* None
Patient Experience and Acceptance of Horizontal Rotation

Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.

Study participants will be asked to attend the clinic on two separate occasions. Each session will last less than one hour. Patients will be asked to complete validated psychometric surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their (baseline) motion sickness, before and after each session. They will then be rotated 3-4 times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to 45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is 9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients will again complete the questionnaire assessing their anxiety levels and motion sickness.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of cancer, any stage
2. ≥18 years of age
3. Eastern Cooperative Oncology Group (ECOG) status 0-2
4. Currently or previously being treated with radiotherapy
5. Any prior therapy allowed
6. Willing and able to comply with all study requirements
7. Must be able to read and complete questionnaires in English
8. Signed, written informed consent

Exclusion Criteria:

1. Pregnant women
2. Mentally impaired patients or patients for whom attaining informed consent would be difficult (including language barriers)
3. Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo
Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region

Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19


Eligibility Criteria:
Inclusion Criteria:

A- For COVID cases:

1. Consultation in a city doctor's office
2. Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
3. Patient symptomatic or not

Definition of symptomatic :

1. Anosmia
2. OR CT scan suggestive of COVID 19
3. OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis

B-. For NON COVID cases:

1. Consultation in a city doctor's office
2. No known COVID+ serology
3. No known RT- PCR SARS-CoV-2
4. No clinical suspicion of COVID-19 infection

Exclusion Criteria:

1. Minor patient
2. Refusal to participate
3. Patient under protection
4. Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)
5. Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge
Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

The primary objectives are:

Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy.

The secondary objectives are:

To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age;
2. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);
3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;
4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;
5. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 109/L
   * Hemoglobin: \> 80 g/L
   * Platelets: \> 50.0 x 109/L
   * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
6. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination;
7. Subject is capable to undergo the diagnostic investigations to be performed in the study;
8. Informed consent

Exclusion Criteria:

1. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

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Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years

Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Type of tumor:

   * Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells).
   * Incompletely resected local medulloblastoma with a residue \> 1.5 cm2.
   * Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection).
   * Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection).
   * Local and/or metastatic sustentorial PNET.
2. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.
3. Age at diagnosis of S-PNET of more than 10 years and less than 20 years.
4. Nutritional and general status compatible with treatment, Lansky score \> 60.
5. Estimated life expectancy \> 1 months.
6. Radiographs must be available for the second reading in dicom format on a CD-ROM.
7. Hematological function at diagnosis: PMN \> 1.0 x 109/l and platelets \> 100 x 109/l.
8. Hepatic function at diagnosis: serum bilirubin \< 1.5 times normal value; ASAT and ALAT \< 2.5 times normal values; prothrombin time \> 50%; fibrinogen \> 1.5 g/l.
9. Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years \< 65 micromol/l; 15 to 18 years \< 110 micromol/l.
10. No organ toxicity (Grade \> 2 according to NCI-CTC coding, version 2.0)
11. No other concomitant anti-cancer treatment.
12. No prior anti-cancer therapy.
13. No prior irradiation.
14. Written informed consent signed by both parents or legal guardians

Exclusion Criteria:

1. Failure to comply with one of the inclusion criteria.
2. Severe or life-threatening infection.
3. Uncontrolled active or symptomatic intracranial hypertension.
4. Refusal of parents or legal guardian.
5. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Confirmed diagnosis of ulcerative colitis (UC)
* Has moderately to severely active UC as defined by 3-component Modified Mayo score
* Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has diagnosis of Crohn's disease or indeterminate colitis
* Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
* Has current or impending need for colostomy or ileostomy
* Has had surgical bowel resection within 3 months before screening
* Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.

Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity. Gaps in the knowledge which we intend to fill are:

1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.
2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months.
3. Analysis of neuropathic pain medication dosages in those with and without TINS at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge

Eligibility Criteria:
Inclusion Criteria:

* Acute tSCI paraplegia within 4 weeks of injury (n=22)
* 18-75 years old
* Neurologic levels T1-T10
* English speaking
* Admitted to TIRR with pain medications
* TINS can elicit visible or palpable abdominal muscle contraction

Exclusion Criteria:

* Subjects with pacemakers, defibrillators, insulin pumps, and similar devices
* History of peripheral neuropathy
* History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.)
* History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative diseases such as Parkinson's disease, etc.)
* Ventilator dependent respiration
* Inability to speak
* Non-English speakers
* Pregnancy
* History of chronic pain
* Intolerant to electric stimulation
* Intolerant to the trial sessions