cyrilzakka/clinical-trials huggingface dataset:
Postpartum Intrauterine Device Study

The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.

The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.

Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.

Eligibility Criteria:
Inclusion Criteria:

* Primary Inclusion Criteria:

  * Ages 18-45 attending prenatal care
  * Greater than 34 weeks estimated gestational age
  * Desire to use the CuT380A-IUCD for contraception postpartum
  * Plan to stay in the area for at least 5 months postpartum
  * If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
  * No prior cesarean delivery
  * No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
  * No known uterine anomalies
  * No known pelvic tuberculosis
  * No known genital tract cancer
  * No known allergy to copper
  * No known history of ectopic pregnancy within 3 months prior to pregnancy.
  * No evidence of clinical anemia as assessed by a clinician at enrollment
  * Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery

Secondary Eligibility Criteria

* Vaginal delivery within the last 48 hours
* No postpartum hemorrhage documented by the delivering clinician
* Not known to have ruptured membranes for greater than 24 hours prior to delivery
* No infection diagnosed by a clinician
* No fever of greater than 38° during labour or delivery
* Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.

Exclusion Criteria:

* prior cesarean section
* fever during labor and delivery
* AIDS, not well on antiretroviral therapy
* genital tuberculosis
* known uterine abnormalities or genital tract cancer
* history of ectopic pregnancy within 3 months of current pregnancy
Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound

This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.

The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
* Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
* Baseline NRS pain score \> or = to 4
* Refractory to oral analgesic therapy

Exclusion Criteria:

* ongoing litigation issues related to the patient's pain
* pregnancy
* allergy to steroids or local anesthetics
* multiple comorbidities
* BMI \> 35
EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).

This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 years
* ECOG performance status 0-1
* Adequate haematological function, coagulation, liver function and renal function
* Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
* TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
* Measurable or evaluable disease (according to RECIST 1.1 criteria).
* Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

Exclusion Criteria:

* - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.

Patients with any known significant ophthalmologic anomaly of the ocular surface

* Patients who received prior chemotherapy for metastatic disease
* CNS metastases
* Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
* Pregnancy
Psychometric Properties of the Turkish Version of S-ROM-Neck

Patient-reported joint motion assessment tools have been developed and applied successfully in several joints of the body. "The Self Administered Neck Mobility Assessment Tool (S-ROM-Neck)" questionnaire was developed by Langenfeld et al in 2018. With this questionnaire, the clinicians are able to evaluate the neck joint motion perception of the patients, subjectively. There is no Turkish version of the questionnaire. The aim of our study is to develop the Turkish version of the S-ROM-Neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.

Neck pain leads to a decreased range of motion in the cervical spine, bringing along functional losses. As a result, this situation is associated with many disabilities. Evaluation of neck joint motion is essential in patients with chronic neck pain. It is used to evaluate the neck pain level and functional deficit level of the patient. In this way, it is possible to evaluate the effectiveness of the treatment applied to the patient during the rehabilitation process. Generally, this evaluation can be made and interpreted by an experienced clinician. However, patient perception provides a better understanding of patients' needs and problems by converting clinical data into a patient-centered measure. Moreover, the patient's perspective can add valuable information to the examination by creating a holistic picture of the patient's problems, possible needs, and expectations. In 2018, the "Self Administered Neck Mobility Assessment Tool (S-ROM-Neck)" survey was developed by Langenfeld et al. With this questionnaire, developers purposed to evaluate the neck joint motion perception of the patients, subjectively. There is no Turkish version of the questionnaire. The aim of our study is to develop the Turkish version of the S-ROM-Neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.

Eligibility Criteria:
Inclusion Criteria:

* To have neck pain for at least 3 months.
* Turkish literate individual

Exclusion Criteria:

* Operation history due to neck pain problems
* Individuals diagnosed with tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
* Pregnancy
* Individuals who do not give consent
Diagnosing Intensive Care Unit (ICU) Acquired Weakness

The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.

The primary purpose of this study is to develop a procedure to identify intensive care unit (ICU) acquired weakness. This condition occurs in a subset of people admitted into the ICU, and is associated with a 30% increased risk of death before discharge from the ICU. There are currently major limitations in the ability to diagnose ICU acquired weakness, making it difficult to study. The goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. The current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. This study is designed to test out the procedures in patients who have been transferred from the ICU to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients transferred from the ICU to a lower level of care within the past 7 days
* Mechanical ventilation for greater than 7 days while in the ICU
* Ability to understand English and provide written consent

Exclusion Criteria:

* Vulnerable populations including: patients who are pregnant or prisoners
* Patients who are unable to understand English or provide written consent
Intraductal Meibomian Gland Probing Trial

In this research study, the investigators are looking at the effects of Meibomian Gland Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already tried traditional management with no success in resolving their clinical signs (as seen by their ophthalmologist) or their symptoms.

The investigators are also evaluating the effects of using two (2) post-procedural medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP procedure has an effect on its outcome.

Dry eye disease is one of the most common conditions seen in ophthalmic practice and is associated with significant patient distress. Meibomian gland dysfunction (MGD) is among the most prevalent causes of dry eye disease. This condition, which is often due to obstruction of the meibomian gland orifices, may result in significant ocular irritation. Traditionally, management of MGD includes warm compress, lid hygiene, and anti-inflammatory medications. This randomized clinical trial is designed to evaluate the effects of meibomian gland probing versus sham procedure in cases with refractory MGD that do not respond to traditional treatments. Moreover, the effects of postoperative regimen will also be investigated using two different regimens. In addition to symptoms, the changes will also be evaluated in terms of clinical signs as well as in vivo confocal microscopy (IVCM) which allows study at the cellular level.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-89 years
* Willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* Diagnosis of meibomian gland dysfunction (MGD)
* Symptoms of MGD such as foreign body sensation, burning, stinging, light sensitivity for at least 3 months
* Persistent symptoms despite at least 3 months of medical management including lid hygiene, warm compress, and use of topical and systemic therapy, or contraindication to systemic therapy
* Presence of lid tenderness on the upper lids in both eyes
* Tear break-up time (TBUT) of \<10 seconds
* In good stable overall health

Exclusion Criteria:

* Active allergies to steroids, sulfacetamide, GenTeal PM Night-Time ointment, or lidocaine
* Intraocular surgery or ocular laser surgery within 1 month before enrollment
* History of ocular infection within 1 month before enrollment.
* History of increased intraocular pressure after using topical steroids (steroid responsive)
* Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study
Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
4. Karnofsky score ≥ 70.
5. Subjects aged ≥ 18 years and ≤ 70 years.
6. No evidence of para-aortic metastatic lymph nodes.
7. No contraindications to CT scanning.
8. Subjects must be able to cooperate in completing the entire study.
9. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
10. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

Exclusion Criteria:

1. Subjects who have received prior pelvic radiotherapy.
2. Subjects with other primary malignancies.
3. Subjects with contraindications to radiotherapy, as determined by the investigators.
4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
5. Active infection with fever.
6. Active inflammatory bowel disease.
Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels

Rationale of this research is to compare the effect of instrument assisted soft tissue mobilization and dynamic oscillatory stretch technique on gastro soleus muscles flexibility with shortened calf muscle-tendon unit (MTU),thicker and stiffer Achilles tendon in individual wearing high heel. This study will observe effect in all range of motion of ankle joint. In Pakistan no previous research is conducted, that compare the effect of IASTM and DOST in females wearing high heel.

Regular wearing of high heels would lead to shortening of the fascicles of the gastrocnemius muscle together with changes in the mechanical properties of the Achilles' Tendon, by the continuous ankle plantar flexion cause by the heel lift resulting in functional alteration. The purpose of the study is to identify the optimal technique for alleviating the symptoms in patients with high heel syndrome. It is a randomized controlled trial.Sample size is total 54 participants which would be divided into two groups, 27 each.Non-probability Convenience Sampling will be used and participants are randomly assigned into GROUP A(IASTM) and GROUP B (DOST) through sealed envelope methods after baseline assessment. All participants in both groups were evaluated on two occasions: (i) baseline (ii) at 12th session.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years
* Duration of wearing heels: minimum 1 year
* Wearing heels for minimum 3 times a week and 5 hours a day.
* Heel height: 2" and above
* Ankle Dorsiflexion ROM: decreased dorsiflexion (about 17 degrees)
* Pain scale showing more than 3.

Exclusion Criteria:

* DVT
* Musculoskeletal injury or surgery of lower limb.
* Acute Cardio-Respiratory or Neurological condition.
* Medical or surgical co-morbidities
A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer

This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer.

Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study.

Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication.

Response evaluation will be done every 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of bladder/urachal remnant that is clinically consistent with urachal cancer.

Origin in the anterior wall or dome of the bladder Predominant invasion of muscularis or deeper tissues No obvious origin from the overlying urothelium (relative normal-looking urothelial mucosa) No primary adenocarcinoma elsewhere

* Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
* No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous 5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim is allowed if it ended more than 6 months before enrollment.
* Measurable disease according to RECIST v1.1 criteria
* ECOG performance status 0 or 1
* Age 19 years or older
* Adequate cardiac function
* Adequate bone marrow, hepatic, and renal function Hematology
* Life expectancy more than 3 months
* Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Age \> 65
* Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted unless the lesion is the only measurable lesion
* Uncontrolled CNS metastasis (brain and/or leptomeningeal metastasis)
* Grade 2 or more peripheral neuropathy
* Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
* Pregnancy or breast feeding, or intention of becoming pregnant during study treatment or within 6 months after final dose
* Other severe acute or chronic medical or psychiatric condition
* Chronic diarrhea
* Clinically significant cardiac disease (heart failure, coronary artery disease, and/or arrhythmia)
* Hypersensitivity to study medication
* treatment with a prohibited medication or anticipation of need for prohibited medication ( section 5.5 )
Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated with Proton Therapy for a Large Choroidal Melanoma

The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Choroid melanoma more than 7mm thick and / or over basal diameter of 15mm treated by proton therapy

Exclusion Criteria:

* Iris melanoma
* Melanoma immediately metastatic
* Pregnant or breastfeeding women
* Known hypersensitivity to aflibercept (anti-VEGF selected)
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).

This study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB). The study will focus on neonates for a few reasons. Although their post-CPB clinical course is typically more severe and intensive care unit (ICU) care more prolonged than older children, their modes of morbidity are also well characterized. Further, the high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. Finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population. The well characterized scenario of low cardiac output syndrome (LCOS) will be used as the primary endpoint, while a variety of secondary endpoints will be related to the biochemical anti-inflammatory effects of therapy, ICU care and late neurological outcome.

Eligibility Criteria:
Inclusion Criteria:

* Neonates Age \</= 1 month
* Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)
* Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion Criteria:

* Prematurity: \</= 36 weeks post gestational age at time of surgery
* Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery
* Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization
* Suspected infection that would contraindicate steroid use (eg - Herpes)
* Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)
* Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization
* Inability to begin the pre-operative study drug at least 8 hours prior to surgery