cyrilzakka/clinical-trials huggingface dataset:
PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum (Non-mucinous adenocarcinoma)
2. Clinical stage IIIC/IV, and IIIC with Suidan CT ≥3 or Fagotti ≥8
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 2
4. Not received any immunotherapy before
5. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. With other uncontrolled malignant tumors.
2. Any disease requiring systemic treatment with a corticosteroid (prednisone or equivalent daily dose of \> 10mg) or other immunosuppressive agents during the 14 days prior to randomization.The use of topical substitute steroids (daily dose ≤10mg of prednisone or its equivalent) and prescription corticosteroids for short-term (≤7 days) prophylactic use or for the treatment of non-autoimmune conditions is permitted.Has any active autoimmune disease or a history of autoimmunity.
3. A history of active autoimmune disease or autoimmune disease that may recur.Enrolment was allowed for well-controlled type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, well-controlled celiac disease, skin conditions (such as vitiligo, psoriasis, or alopecia) that did not require systemic treatment, or conditions that were not expected to recede without an external cause.
4. A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.).
5. Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen \[HBsAg\] test result and HBV-DNA test value higher than the upper limit of normal value in the laboratory of the research center) or hepatitis C (defined as positive hepatitis C virus surface antibody \[HCSAB\] test result and positive HCV-RNA test result).
6. Known human immunodeficiency virus (HIV) infection (known to be HIV positive).
7. Have received live vaccine within 30 days before the first administration.This includes but is not limited to the following: mumps, rubella, measles, varicella/herpes zoster (varicella), yellow fever, rabies, BCG and typhoid vaccines (inactivated virus vaccines are allowed).
8. With uncontrolled cardiac clinical symptoms or diseases.
9. Allergic to any drug in this program.
10. At the discretion of the Investigator, the subject has a history or current evidence of any disease, treatment or laboratory anomaly that may confuse the results, interfere with the participants' participation throughout the study, or is not in the best interest of the participants to participate in the study.
Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
* Age between 18 and 65 years.
* Duration since amputation is at least 6 months.
* Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
* Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
* Signed consent to participate in the study.

Exclusion Criteria:

* Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
* Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
* Presence of severe orthopedic deformity in the limb above the level of amputation.
* History of cancer.
* History of epilepsy.
* Complicated traumatic brain injury (TBI) or a history of stroke.
* Inability to undergo electrostimulation due to other somatic pathology.
* Purulent-septic pathology.
* Drug addiction (including a history of).
* Congenital anomaly of upper limb development.
* Anomalies in the development of the central and peripheral nervous systems.
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

The goal of this randomized controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF).

The main questions are:

* Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)?
* Does it improve secondary outcomes such as embryo quality, pregnancy rates, inflammation markers, and quality of life?

Researchers will compare two groups:

* Women receiving standard IVF protocols.
* Women undergoing the same IVF protocol plus the anti-inflammatory diet.

Participants will:

* Be randomized into one of the two groups.
* Follow dietary counseling sessions and complete dietary assessments (diet group).
* Provide biological samples (e.g., plasma, vaginal and fecal swabs, and follicular fluid) before and after the dietary intervention to evaluate potential differences in inflammation, hormonal levels, and microbiome composition between the two groups and across timepoints (pre- and post-diet).
* Complete questionnaires on quality of life, sexual function, and symptomatology severity before and after the intervention to assess differences between the two groups and across timepoints.

Women who agree to participate in the study will be randomized into two groups: one group will receive standard IVF protocols, and the other will undergo a 12-week anti-inflammatory diet followed by the standard IVF protocol. In both groups, participants' dietary habits will be monitored throughout the study period to detect any variations. The primary outcome will be to compare the rate of inadequate ovarian response to hormonal stimulation (defined as the retrieval of ≤3 oocytes according to the Poseidon 2016 criteria) in infertile women with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years
* Pregnancy seeking for more than 12 months
* Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days
* Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.
* Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve).
* Absence of ureteral stenosis or intestinal subocclusive symptoms

Exclusion Criteria:

* Contraindication to pregnancy
* Hydrosalpinx
* Endometriomas with a mean diameter \> 4 cm
* Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
* Doubtful sonographic findings that do not allow to reliably rule out malignancy.
* severe male factor (\<1 million sperm/ml)
Efficacy of Hypopressive Exercises Versus Pilates in Women with Abdominal Diastasis in the Postpartum Period: a Randomized Controlled Trial

The aim of this study is to compare the effects of two exercise programs in women with abdominal diastasis (AD) during the postpartum. One group will receive hypopressive exercises (HE) and the other will receive pilates exercise. The hypothesis of this study is that the execution of both protocols will offer benefits in the ultrasound values of the AD and in the data collected on the quality of life in the short term and 12 weeks after its completion.

Objective: To compare the efficacy of hypopressive exercises (HE) versus pilates exercise in women with abdominal diastasis (AD) during the postpartum, and to know the effects of each of the exercises independently.

Design: Single-blind randomized controlled trial.

Setting: Faculty of Physical Therapy of Alcalá de Henares (UAH).

Participants: Primiparous women with DA who have vaginal delivery and are in the 3 months postpartum (N=40).

Interventions: Participants will be randomly assigned to perform either a HE program focused on freediving work (n=20) or a pilates program focused on exhalation (n=20). The intervention will consist of 3 weekly sessions lasting 30 minutes over 12 weeks, where they will receive a weekly face-to-face and group session and two home sessions.

Main outcome measures: The primary outcome will be measurement of the distance between rectus abdominis through ultrasound to be assessed at baseline, immediately after the intervention and 12 weeks later. The secondary outcome measure will correspond to the measurement of quality of life using the SF-36 Health Questionnaire. It will be collected through masked evaluations by 2 physiotherapists at baseline, at the end of the intervention and at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women over 18 years of age who are within 3 months postpartum.
* AD with values \&amp;gt;2.5 cm in any of the following reference points: 2 cm supraumbilical or 2 cm infraumbilical.
* Vaginal birth.

Exclusion Criteria:

* Abdominal or umbilical hernia.
* Previous abdominal surgery.
* Be receiving any other treatment for your AD
General Practice Research Database Seroquel XR Safety Study

The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.

Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

Eligibility Criteria:
Inclusion Criteria:

* Episodes of new use (\>/=1 prescription) of quetiapine XR or other study drugs

Exclusion Criteria:

* Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
* If the duration and dose of the antipsychotic drug cannot be determined
BIC: Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals

Different studies showed large variation between care processes in multiple diseases, which lead to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Since international studies have demonstrated wide variations in care processes for acute stroke, it would be interesting to repeat these investigations in the population of stroke patients. Worldwide, stroke is a leading cause of disability and death. Every two seconds, someone across the world experiences a symptomatic stroke. 50% of stroke survivors has moderate to severe neurologic deficits, 25% of them depend on others. In Belgium, stroke is one of the most important causes of invalidity. Every year approximately 18 000 people in Belgium experiences a stroke, which results in almost one person every two hours, with a mortality rate of 30%. The world health organization has the ambition to significantly reduce the mortality and risk factors for non-communicable diseases by 2025. The mortality and disability in stroke patients can be reduced by organized stroke care, which includes effective strategies in stroke management, treatment and prevention. Also, other health domains, like functional recovery, healthcare costs and patient satisfaction, were positively related to adherence on stroke guidelines. This evidence had been converted in several clinical guidelines for stroke care. However, the adherence to these guidelines is variable. As already mentioned before, international studies have demonstrated wide variations in care processes for acute stroke. However, a positive relationship has been shown between the implementation of evidence-based clinical guidelines and the quality of stroke care. Therefore, it is important to both implement these guidelines and to improve the adherence to them.

The aim of this study is to map the variation in stroke care in Flemish hospitals and to get an overview about the variation within and between these hospitals. During this study, electronic patient records will be analyzed to check which interventions are performed in a specific patient and of which no information could be found in de patient record.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Admitted to the emergency department and diagnosed with an ischemic stroke

Exclusion Criteria:

* Diagnosed with cerebral venous thrombosis
* Diagnosed with hemorrhage
* Thrombectomy performed
BMAC Loaded Collagen Jumping the Gap Around Immediate Implants

The present study aims to evaluate the effect of utilization of BMAC/ collagen on marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in the esthetic zone and patients will be randomly divided into two groups:

study group: The jumping gap surrounding the immediate implants will be grafted with BMAC/collagen, whereas in the control group, autograft from the chin will be used to fill the defect. Cone beam CT (CBCT) will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around implants.

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The aim of present study is to evaluate the effect of utilization of bone marrow aspirate concentrate (BMAC) loaded on collagen on the marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in patients suffering from non- restorable teeth in esthetic zone.

Patients will be randomly divided into two equal groups:

study group: The jumping gap surrounding the immediate implants will be grafted with bone marrow aspirate concentrate loaded on collagen, whereas in the control group, autogenous bone graft from the chin will be used to fill the peri-implant defect. CBCT will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around dental implants.

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Eligibility Criteria:
Inclusion Criteria:

* Patients with non- restorable teeth in esthetic zone
* Patients above 18 us
* Highly motivated patients.

Exclusion Criteria:

* patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders
Platelet Rich Plasma Study in Lower Extremity Bypass Surgery

The use of platelet rich plasma will decrease wound infection postop.


Eligibility Criteria:
Inclusion Criteria:

* Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision Exclusion Criteria:Patients requiring emergent procedures, unable to give informed consent
AgeTeQ Database Management Framework

The AgeTeQ "Arts, health and new information and communication technologies (NICTs)" laboratory database contains all the clinical and paraclinical data of participants in clinical research projects carried out by the AgeTeQ laboratory on the themes of the arts, and/or health, and/or NICTs.

The database can thus contain quantitative data (i.e. non-invasive measurements taken with questionnaires or measuring devices providing numerical values such as blood pressure, heart rate or electrical activity of the brain, etc.) and qualitative data (i.e. extracted from a verbatim in the context of guided interviews) from participants in the above-mentioned clinical research projects. These data can take the form of spreadsheets containing numerical values, written documents such as verbatims, and audio or video recordings.


Eligibility Criteria:
Inclusion Criteria:

* Had participate to a previous research project managed by the administrator of the databank
* Agreed to integrated the databank

Exclusion Criteria:

* Less than 18 years old
Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40;

Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:

1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tiralizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.


Eligibility Criteria:
This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:

1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tislelizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records.
Effects of Resistance Training and Supplementation in Elderly: Cardiorespiratory and Metabolic Variables

Aging causes losses in strength, lean mass, and cardiovascular health in the elderly due to metabolic changes and alterations in body composition. To investigate whether nutritional interventions and physical training can mitigate these effects, a randomized clinical trial will be conducted at the Evangelical University of Goiás with elderly individuals aged 60 to 85. Participants will be divided into four groups: control, protein supplementation, physical training, and a combination of both. The study will last for 12 months, with evaluations every four months, covering cardiovascular, pulmonary, immunological, renal, muscular, and hematological parameters. The analyses will seek statistical significance, and it is expected that the interventions will significantly improve the participants\&#39; health.

The aging process is associated with declines in strength, lean mass (LM), and cardiovascular (CV) and cardiorespiratory (CR) health due to metabolic, hemodynamic, and body composition changes in the elderly. The implications of these changes can potentially be mitigated through nutritional intervention and physical training. To test this hypothesis, a randomized clinical trial will be conducted at the Evangelical University of Goiás (UniEVANGÉLICA), where elderly volunteers (aged 60 to 85) will be randomized (n = 40/group) into control groups (no protein supplementation and no physical training), supplementation group (only protein supplementation), training group (only physical training), and a combined group (physical training + protein supplementation). The supplementation and training protocols will be conducted for 12 months, with evaluations occurring before the protocol begins and every four months thereafter. Numerous cardiovascular, pulmonary, immunological, renal, muscular, and hematological parameters will be assessed. Analyses will be expressed as mean and standard deviation, with a significance level of p≤0.05 for paired t-tests and multiparametric analyses. It is expected that the effects of the resistance training and protein supplementation protocols, together or separately, will significantly improve the described parameters, yielding positive results for the participants.

Eligibility Criteria:
Inclusion Criteria:

- Individuals who volunteer to participate in the study must sign the Informed Consent Form (ICF), be willing to participate in all assessments, and maintain a minimum attendance of 75% in the classes.

Exclusion Criteria:

* Individuals with neurological diseases that prevent them from participating in the assessments and the physical training program will not be eligible.
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

Aim: The aim of this study is to assess the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors.

Hypotheses:

H1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray does not reduce venipuncture pain during blood donation.

After being informed about the study and potential risks, all patients giving written informed consent. Before the procedure was begun, the donors who agreed to participate in the study were met face-to-face and asked to fill in the "Informative Characteristics Form", the "VAS", the "Blood/Injection Fear Scale" and the "STAI-I" forms.Then the donors were assigned to their groups by the researcher.The donors in the control group were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group. During the blood collection procedure, after the donors' skin was cleaned with antiseptic solution, spray was applied to the application site for a maximum of 10-15 seconds from a distance of 25 cm. In both groups, immediately following venipuncture, pain assessment was made with the VAS by the researcher, who did not know which group each participant belonged to.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 35
* BMI between 18.5 and 24.9 kg/m2
* speaks turkish
* male donor
* individuals who applied to make voluntary blood donations
* volunteers to participate in the study

Exclusion Criteria:

* donors who did not agree to take part in the study,
* donors with open wound, scar, infection, dermatitis, eczema or lesion at the venipuncture site, or donors with cold allergy
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:

* Study the changes in gut bacteria by examining saliva, stool and blood.
* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.
* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.

Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-90 years
* Patients who underwent oesophagectomy for oesophageal adenocarcinoma with curative intent
* Disease free patients (CT with no evidence of recurrence within last 6 months or more than 5 years post oesophageal resection)
* Patients more than 1 year post oesophageal resection

Exclusion Criteria:

* Patients with Siewert III gastro-oesophageal junctional tumours
* Patients with evidence of disease recurrence
* Patients who are unable or unwilling to provide informed written consent
* Patients who have received antibiotic therapy within the last 4 weeks