cyrilzakka/clinical-trials huggingface dataset:
Role of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome

This prospective study aims to evaluate the median nerve in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies.

This prospective study aims to evaluate the median nerve anatomical changes in Carpal Tunnel Syndrome by high-frequency ultrasound and color Doppler in comparison with clinical and Nerve conduction studies physiological changes to determine the efficacy of ultrasound to diagnose and determine the severity of carpal tunnel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Any Age Group with symptoms, clinical signs and NCS consistent with CTS

Exclusion Criteria:

* Uncooperative Patients .
* Patients with History of previous wrist surgery, fracture or traumatic nerve injury
Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation

Fractures of the distal radius are one of the most common orthopaedic injuries and are associated with a high complication rate. There is a lack of clinical trials comparing the different treatment modalities of fractures of the distal radius. The purpose of this randomized trial is to assess differences in functional outcome, radiological results, and complication rate in patients 55 years and older with an unstable displaced fracture of the distal radius without articular involvement treated with a dorsal nail plate or a volar plate.

Surgical treatment is needed for distal radius fractures that can not be treated with a simple plaster cast, and is indicated in a substantial amount of these patients. There is a well known correlation between a good anatomical result and a good functional outcome for the patient. The most common methods for operative fixation are external fixation with a metal frame, percutaneous pin fixation, and open surgery with insertion of a metal plate and screws on the dorsal or the volar side of the fracture. Biomechanical studies have shown differences in mechanical stability between different plate fixation systems.

The investigators are conducting this randomized trial to investigate the differences in outcome after treatment with a DVR volar plate and a DNP dorsal nail plate. The DVR volar plate follows the same principles of fixation as other volar plates using locking screws and/or pegs. It has smooth or threaded pegs that are multidirectionally placed in the distal part of the plate. The dorsal nail plate (DNP) is a relatively new implant that is inserted through a less invasive technique, with a minimum of soft tissue exposure. It is inserted through a 3-4 cm long incision on the dorsal side of the wrist and is introduced into the medullary canal. It is fixed with screws on the proximal (nail) side of the fracture and threaded or smooth locked multidirectional pegs on the distal (plate) side of the fracture. It has been suggested as a good alternative to regular plate fixation where less invasive surgery is desired. Clinical patient series have been published showing good clinical results.

There are no clinical trials comparing these two types of treatment. Therefore the investigators want to conduct a randomised controlled trial, with the purpose of finding potential differences in functional outcome for the patients.

Eligibility Criteria:
Inclusion Criteria:

* Unstable dorsally displaced fracture of the distal radius without articular involvement
* Age 55 years or older

Exclusion Criteria:

* Previous fracture of the same wrist
* More than one acute fracture (except the ulnar styloid process)
* Open fracture
* Mental impairment or unable to understand and sign an informed consent
* Fracture older than 14 days
Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail

To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

During physical exercise, increased sympathetic nervous system activity redistributes blood flow from splanchnic organs to working muscles. With prolonged duration and / or intensity, the splanchnic blood flow can be reduced by 80% or more. A severely reduced of splanchnic blood flow can frequently cause gastrointestinal ischemia. This ischemia associated with reduced vagal activity probably results in changes in motility and absorption.

High symptoms are reported in 40% of runners with reflux and heartburn in 15-20% of runners. The low symptoms have an incidence of about 70% in the long runs type ultra-trail.

Biological markers such as I-FABP have been shown to be useful in the diagnosis of mesenteric ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Voluntary Subject
* Age \> 18 years
* Written consent
* Subject affiliated to Social Security
* Medical certificate (mandatory to take part in the ultra-trail)

Exclusion Criteria:

* Refusal to participate
* Subject with legal protection (guardianship, trusteeship)
Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy

Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy).

Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score).

Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2.

Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment.

For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Erectil dysfunction after radical prostatectomy less than two years ago
* IIEF - less than 20
* EHS - less than 4

Exclusion Criteria:

* drop out
* not sexual active
* penile prostesis
The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study

To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Men and women aged 18-85 years
* 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
* 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
* 4. Excluding lymph node dissection \< 15, (meeting the guideline criteria)
* 5. The tumor located in the lower middle thoracic.

Exclusion Criteria:

* 1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
* 2. Patients with distant metastasis confirmed by imaging
* 3. Patients with obvious surgical contraindications.
DT-9081 Study in Participants with Advanced, Recurrent or Metastatic Solid Tumours

This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended phase 2 dose (RP2D) of DT-9081, followed by an expansion study of DT-9081 in participants with advanced, recurrent or metastatic solid tumours

This first-in-human Phase 1, multicentre, open label study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumours who failed standard of care therapies.

This Phase 1 study consists of 2 parts. The first part is a dose-escalation using a modified 3+3 design with up to 8 dose escalation cohorts at increasing levels. The dose-escalation part aims at determining the recommended phase 2 dose. The second part is an expansion to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081.

Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a histologically or cytologically confirmed advanced solid tumour that is locally advanced (i.e., not eligible for curative surgery or radiotherapy), recurrent or metastatic, and who have failed or are ineligible for standard of care therapies.
* Participants must be ≥18 years of age.
* Participants must have measurable disease per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Participants must have adequate organ function.

Exclusion Criteria:

* Participants using drugs interfering with the COX-2 pathways or prohibited drugs.
* Participants with unresolved AEs from previous anti-cancer therapies of Grade ≥ 2 with exception of alopecia. Participants with Grade ≤ 2 neuropathy may be eligible.
* Participants who underwent major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 who have not recovered adequately from any AEs and/or complications from the intervention prior to starting study drug.
* Participants who have received prior radiotherapy within the last 4 weeks before start of study drug treatment (limited field palliative radiotherapy within 2 weeks).
* Participants who have already received EP4R antagonist in an investigational trial.
Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity

Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors.

Objective: The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries (primary outcome). Secondary outcomes include assessing the clinical performance of the self-cure composite resin in terms of restoration longevity and comparing the effectiveness of three interventions-photobiomodulation combined with self-cure resin, self-cure resin alone, and photobiomodulation combined with bulkfill photopolymerizable resin-in controlling hypersensitivity over time.

Methods and analysis: Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups. Group 1: photobiomodulation + self-cure composite resin restoration; Group 2: self-cure composite resin restoration; Group 3: photobiomodulation + restoration in bulk-fill photopolymerizable composite resin. Photobiomodulation will be performed in a single session involving low-level laser administered to four different points. The laser will be used at a wavelength of 808 nm, power of 100 mW and energy of 1 J per points; irradiance will be 3571 mW/cm², with a total radiant exposure of 35.7 J/cm². Data normality will be checked using the Shapiro-Wilk test, and variance homogeneity will be assessed with the Levene test. Descriptive statistics will be used to present the data, with continuous variables expressed as mean and standard deviation, and categorical variables by relative frequency. To compare the VAS and SCASS scales, repeated measures ANOVA will be employed, considering the 3 groups and 5 time points. Bonferroni adjustment will be applied for post-hoc comparisons. Sphericity will be tested with Mauchly's test, and if violated, Greenhouse-Geisser correction will be applied. A significance level of 0.05 will be adopted. Ethics and dissemination: This protocol received approval from the Human Research Ethics Committee of Nove de Julho University (certificate number: xxxxxxx). The legal guardians of the children will agree to participation by signing a statement of informed consent. The results will be published in a peer-review journal and the data will be made available upon request.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children;
* Eight to 12 years of age;
* At least one permanent first molar with MIH (codes 5 and 6 of molar-incisor hypomineralization severity scoring system \[MIH-SSS\])
* Presence of hypersensitivity
* Direct viewing and access.

Exclusion Criteria:

* Clinically: signs or symptoms of pulp involvement;
* Radiographically: evidence of pulp involvement (initial periapical radiograph);
* Teeth with MIH with no indication for direct restorative treatment (multiple surfaces associated with large extensions);
* Partially erupted teeth;
* Previous restorative treatment.
How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score

Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice.

Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older diagnosed with Acute calculous cholecystitis.
* Consecutive patients undergoing early laparoscopic cholecystectomy between January 2013 and December 2018 during admission for the acute episode.
* Minimum 30-day post-operative follow-up.
* ASA ≤ 3.

Exclusion Criteria:

* Presence of another concomitant pathology of the bile duct (choledocholithiasis, cholangitis, pancreatitis, biliary peritonitis).
* Aetiology other than cholelithiasis (amythiasis, malignancy).
* Patients with severe sepsis, immunosuppression and pregnancy.
* Additional abdominal surgical procedure.
* ASA 4.
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.

The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

Eligibility Criteria:
Inclusion Criteria:

* Age at recurrence ≥ 18 years
* Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
* A complete secondary cytoreduction predicting score, iMODEL \[Tian WJ, Ann Surg Oncol 2012,19(2):597-604\]\<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013)
* Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.
* Patients who have given their signed and written informed consent and their consent.

Exclusion Criteria:

* Patients with borderline tumors as well as non-epithelial tumors.
* Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
* Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.
* More than one prior chemotherapy.
* Second relapse or more
* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Progression during chemotherapy or recurrence within 6 months after first-line therapy
* Any contradiction not allowing surgery and/or chemotherapy

  1. Accompanied by hypoxia serious chronic obstructive pulmonary disease
  2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
  3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
  4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
  5. Uncontrolled diabetes
  6. Uncontrolled epilepsy need long-term antiepileptic treatment.
* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)

The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.

This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings.

This study will enroll approximately 200 participants in the following cohort:

• Brigatinib 90 mg/180mg

This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation.

This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.

Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 18 years.
2. Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
3. Participants with ALK gene rearrangement confirmed by local hospital medical records.
4. Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
5. Participants who have at least one medical record after the start of brigatinib treatment.

Exclusion Criteria

1. Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
2. Previously received any other TKIs, including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
4. Participants have been diagnosed as malignancies (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in addition to NSCLC within the past 5 years.
Vitamin D Treatment and Hypocalcemic Pregnant Women

* Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
* Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
* Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
* At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.


Eligibility Criteria:
Inclusion Criteria:

gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -

Exclusion Criteria:

moderate to sever hypocalcemia(ca\<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs

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