cyrilzakka/clinical-trials huggingface dataset:
The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery

This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the surgery.

Gut microbiota dysbiosis is associated with the pathophysiology of obesity. Bariatric surgery is an effective treatment for obesity that induces changes in the gut microbiota. However, recent studies indicate that the gut microbiota is not fully restored after bariatric surgery which may limit the potential of the surgery to achieve metabolic control and maintain weight loss. Thus, modulating the gut microbiota with probiotics after bariatric surgery could be an effective strategy to improve the success of the surgery.

This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 65 years
* BMI ≥35 kg/m2 and at least one severe obesity-related complications, or BMI ≥40 kg/m2
* Undergoing Roux-en-Y gastric bypass
* Willing to take a probiotic/placebo supplement twice a day for 60 days
* Willing and able to provide written informed

Exclusion Criteria:

* Intake of antibiotics and/or probiotics in the previous 12 weeks
* Weight change \>5% in the previous 12 weeks
* Diagnosis of gastrointestinal disease or other significant illness
* Pregnancy or breastfeeding
Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region

Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the abdominal-pelvic region.

Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment.

Various primary tumors as well as metastases of various origins can be localized in the abdominal-pelvic anatomical region.

Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments. Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the abdominal-pelvic region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the abdominal-pelvic region for:

   Primary tumors of the gastrointestinal tract, Primary tumors of the male and female reproductive systems, Primary tumors of the urinary system, Primary tumors of the cardio-circulatory system, Primary tumors of the lymphatic system, Primary tumors of the nervous system, Skin tumors, Secondary abdominal-pelvic localizations of various origins, Primary or secondary bone or soft tissue lesions of the lumbosacral spine and pelvis.
2. Signed informed consent

Exclusion Criteria:

1. Radiotherapy in districts other than the abdominal-pelvic region
Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy

One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.

We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.

Eligibility Criteria:
Inclusion Criteria:

* These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass

Exclusion Criteria:

* A body weight loss greater than 10% during the six months prior to surgery
* The presence of distant metastases
* Seriously impaired function of vital organs due to respiratory, renal or heart disease
Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis

Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients compared with Loratadine.The double blind randomized controlled trial study was approved by the Human Research Ethics Committee of Thammasat University NO.1.

The double blind randomized controlled trial study. Patients who meet the inclusion criteria and do not fall into any exclusion criteria will be randomly placed into the experimental group, who will receive ginger extract capsules, or the control group, who will receive loratadine for 42 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
2. These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
3. These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
4. These patients are not pregnant or breastfeeding.
5. These patients have normal BMI and vital signs.

Exclusion Criteria:

1. Those who have taken anti-coagulant and anti-platelet aggregation medications.
2. Those who get serious side effects from Loratadine and ginger allergy.
3. Communication problems especially listening and interview.
Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care

The goal of this clinical trial is to evaluate whether Telemedicine follow-up is a satisfactory and safe alternative to traditional follow-up care for patients treated for early glottic (vocal cord) cancer, particularly those who live far from a specialized head and neck oncology centre (HNOC).

The main questions it aims to answer are:

Is patient satisfaction with Telemedicine follow-up comparable to standard care?

Is the safety of Telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an HNOC?

Researchers will compare patients receiving Telemedicine follow-up in a nearby hospital with standard in-person follow-up at the HNOC, to see if remote evaluation of endoscopic procedures can maintain patient satisfaction and safety outcomes.

Participants will:

Be randomly assigned to either a Telemedicine follow-up group (if they live ≥ 45 minutes from an HNOC) or a standard of care group

Undergo follow-up including HD-laryngoscopy, according to clinical guidelines

Have endoscopy videos evaluated remotely by specialists at the HNOC (= Telemedicine) (intervention group only)

Complete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent TOLS for early stage glottic squamous cell carcinoma (T1 or carcinoma-in-situ)
* a one-way travel time to the HNOC of ≥45 minutes (intervention group) or \< 30 minutes (control group)
* within 2 years postoperatively
* can speak and write Dutch

Exclusion Criteria:

* Patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the HNOC.
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A

Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with severe hemophilia A (\< 2% FVIII:C)
* Subjects with no history of FVIII inhibitor antibody formation
* Subjects with no measurable inhibitor activity
* Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
* Subjects whose current treatment with any CHO rFVIII product
* Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
* Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency

Exclusion Criteria:

* Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
* Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
* Any individual with a past history of severe reaction(s) to FVIII concentrates
* Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
* Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
* Subjects who require any medication for FVIII infusions
Perturbed-balance Training During Treadmill Walking for Stroke Subjects

A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.

For a detailed description of the study, see the Arms and Interventions section.

Eligibility Criteria:
Inclusion criteria:

* Case: community-dwelling, high-functioning stroke survivor
* Control: healthy volunteer, height- and weight-matched to the Case

Exclusion criteria:

* any disease or injury affecting cognition
* any disease or injury affecting balance or gait
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* At least 1 measurable lesion (per RECIST 1.1)
* Provide signed informed consent
* ECOG performance status (PS) of 0-1.
* LVEF ≥ 50% by ECHO or MUGA
* Adequate organ functions
* Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
* Life expectancy of ≥ 3 months.

Additional Inclusion Criteria for Part 2 Expansion Group 9:

1. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.

Exclusion Criteria:

* History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
* History of myocardial infarction or unstable angina within 6 months before Day 1.
* Average QTcF \> 450 ms in males and \> 470 ms in females
* History of clinically significant lung diseases
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
* HIV infection with AIDS defining illness or active viral hepatitis.
* Clinically active brain metastases
* Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
* A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
* Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients

To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.

The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day.

Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered.

A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.

Eligibility Criteria:
Inclusion Criteria:

* The patient is diagnosed with idiopathic Parkinson Disease (consistent with the UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD).
* The patient's Hoehn and Yahr Staging score is ≤ 3 in the "ON" state.
* The patient experiences motor fluctuations with at least 2.5 hours of "OFF" periods in the awake time and has predictable morning "OFF" episodes, which have been consistent within the past 4 weeks.
* The patient currently has a good response to L-DOPA and has been receiving a stable dose of L-DOPA (≥3 doses per day of standard L-DOPA or ≥3 doses per day of Carbidopa and L-DOPA, Extended-Release Capsules) during at least four weeks prior to screening.

Exclusion Criteria:

* The patient has cognitive impairment, defined as a Mini Mental State Examination(MMSE) score ≤ 26 at the Screening Visit.
* The patient has severe disabling dyskinesia
* The patient takes or has taken disallowed recent or concomitant medication (CYP2D6 inhibitors, CYP 3A4 substrate, Dopamine agonists, 5 HT3 antagonists, Anti-viral (Amantadine))

Other protocol defined inclusion and exclusion criteria may apply
Effect of Massage Treatment in Temporomandibular Joint

Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect of massage and its properties in patients with TMD.


Eligibility Criteria:
Inclusion Criteria:

1. Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
2. Patient agreement to participate in the experimental study.

Exclusion Criteria:

1. RDC/TMD II and RDC/TMDIII,
2. Drug and/or removable partial or total prosthesis wearers,
3. Being submitted to any type of physiotherapeutic treatment,
4. Incomplete dentition,
5. History of systemic diseases as diabetes or arthritis,
6. The occurrence of facial trauma,
7. Refusal to assume responsibility with this research.
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

Primary Objective:

To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer.

Secondary Objective:

* To characterize the overall safety profile of SAR439859 administered as monotherapy.
* To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy.
* To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days) of study treatment, and an End of Treatment (EOT) visit at least 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, or upon participant's request.

Eligibility Criteria:
Inclusion criteria :

* Participants must be postmenopausal women.
* Breast adenocarcinoma patients with locally advanced not amenable to radiation or surgery, inoperable and/or metastatic disease.
* Either the primary or any metastatic site must be positive for estrogen receptor (ER) (\>1% staining by immunohistochemistry).
* Either the primary tumor or any metastatic site must be human epidermal growth factor receptor 2 non-overexpressing.
* Patients with at least 6 months of prior endocrine therapy.

Exclusion criteria:

* Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2.
* Significant concomitant illness that would adversely affect participation in the study.
* Patients with a life expectancy less than 3 months.
* Patient not suitable for participation, whatever the reason.
* Major surgery within 4 weeks prior to first study treatment administration.
* Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers.
* Patients with known endometrial disorders, uterine bleeding or ovarian cysts.
* Treatment with anticancer less than 2 weeks before first study treatment.
* Prior treatment with selective estrogen receptor down (SERD)-regulator (except fulvestrant for which a washout of at least 6 weeks is required).
* Inadequate hematological function.
* Inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (ULN).
* Liver function: aspartate aminotransferase \>3 x ULN, or alanine aminotransferase \>3 x ULN. Total bilirubin \>1.5 x ULN.
* Non-resolution of any prior treatment related toxicity to \<Grade 2, except for alopecia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.

To report Cold intolerance by the CISS score in medicolegal patients.

Rationale Cold intolerance is an important finding in hand trauma patients, nerve injury, crush injury, degloving injury or amputation. Cold intolerance as a symptom is probably the least responsive to any known medical treatment.

Perhaps due to the fact that we have no control over it, the consequences for cold tolerance are seldom researched. patients involved in medicolegal claims report more pain and less function than controls. Medicolegal examinations for various indications offer a long-term outcome view for the symptoms of cold tolerance. Therefore, together with Handcentrum we want to translate, improve and test the current PROM for cold intolerance CISS

Objective To report Coldintolerance by the CISS score in medicolegal patients.

Study parameters / Endpoints A validated Dutch version of the CISS A report on 100 CISS scores in medicolegal patients Examine if a shorter version of the CISS questionnaire is feasible

Study design 2-3 independent forward translations (e.g. from English into Dutch) by native speakers of the target language (e.g. Dutch). One of the translators understands the concept, one translator has no knowledge of the concept that the questionnaire measures and no medical background.

The translators make a joint forward translation together with an independent person.

2-3 independent back-translations (e.g. from Dutch into English) by native speakers of the source language (e.g. English). Both translators have no knowledge of the concept the questionnaire measures and have no medical background. ... Read more

Burden and risk These questionnaires are mandatory anyway. So, no additional time for the patients needed. There is no risk involved. There is no alteration in the medical or clinical pathway.

Recruitment and consent automatically enrolment and permission via Medisoft software from HandC

Summary Translation and validation of a Dutch version of a PROM for cold intolerance

Eligibility Criteria:
Inclusion Criteria:

* - Adult
* Traumatic hand injury
* Sufficient knowledge of the Dutch language (at least level B1)

Exclusion Criteria:

* - Definitive total hand amputation
UK Surveillance of Treated Retinopathy of Prematurity

Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined.

The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.


Eligibility Criteria:
Inclusion Criteria:

* Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments)

Exclusion Criteria:

* None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants