cyrilzakka/clinical-trials huggingface dataset:
Pulsed Radiofrequency in Chronic Headaches

Pulsed radiofrequency of the occipital nerves (greater and lesser) for primary headache management.

Patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. They have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain. Inclusion criteria included: not adequate response to systemic pharmacotherapy, pain over crises of \>4/10, occipital tenderness bilaterally or unilaterally, and days with headache of more than 10/month. Exclusion criteria were age\<18 years old, pregnancy or lactation, presence of cardiac pacemaker, previous therapy with PRF, severe psychiatric disorder and patient refusal. In cases of a positive response to the diagnostic nerve block with local anesthetic, with \>50% pain relief they were scheduled for pulsed radiofrequency of GON and LON bilaterally.

Primary outcome measure was the days with headache per month, before and after treatment. In addition, pain during headache crisis (with Visual Analogue Scale, VAS, 0-10), the analgesic consumption (number per month) and the quality of life (measured with EQ6D) were studied. All measurements were performed before treatment, as well as after 1, 3, 6, and 12 months. All patients completed the Brief Pain Inventory questionnaire in Greek language and signed an informed consent prior treatment. All measurements were accomplished by an independed (blinded) researcher of the pain unit. All complications and side effects were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* not adequate response to systemic pharmacotherapy
* pain over crises of \>4/10
* occipital tenderness bilaterally or unilaterally,
* days with headache of more than 10/month.

Exclusion Criteria:

* age\<18 years old,
* pregnancy or lactation
* presence of cardiac pacemaker
* previous therapy with PRF
* severe psychiatric disorder
* severe coagulopathy
* patient refusal
Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

Study aims;

1. To investigate the effect of mobilization as pain management following obesity surgery.
2. To investigate patient experiences with mobilization and postoperative pain, including the influence of mobilization on patients' ability to cope with pain and an identification of facilitating factors and barriers towards early mobilization.
3. To assess the effect of mobilization on postoperative recovery, including the general physical activity level, physical function, and quality of life among patients discharged after obesity surgery.

The PhD study consists of two sub-studies. Study 1: Effect of early mobilization as pain management in patients recovering from obesity surgery. The study is a single center randomized controlled trial (RCT). Participants will be randomized with an allocation ratio of 1:1.

Study 2: Patient experiences with early mobilization and postoperative pain after surgery - An interview study Patients participating in both interventions (group A), will be invited to participate in two individual semi structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* The ability to read and understand the Danish language

Exclusion Criteria:

* Preoperative dependence of walking aids
* Vision impairment
* Previous syncopes or epilepsy
* Admission to the intensive care unit after surgery
* Acute complications during hospital admission
* Patients are excluded at baseline if they have an oxygen saturation below 90% or a systolic blood pressure above 180 mmHg
Real-world Evidence Prospective Study on the Effect of Nab-paclitaxel Treatment on the Clinical Outcomes and HRQoL in Patients With MBC in Greece

This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population. Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

* Adult patients (18 years and older);
* Patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated;
* Patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study;
* Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
* Patients must have signed an informed consent document;
* Patients must be able to read, understand and complete the study specific questionnaire

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

* Patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study;
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
* Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol

This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.

The main objective is to measure jointly and in an automated and standardized manner the performance and motor patterns within the framework of tasks measuring the performance and patterns of general motor skills (postures, walking, coordination overall), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).

The secondary objective is to investigate the relationships between motor difficulties and cognitive and social disorders found in children with ASD.

* Compare the motor performance data in the 3 major motor domains with each other (overall, fine and oculomotor);
* Evaluate intergroup differences based on clinical characteristics (ADOS-2, ADI-R, CARS 2 scores), age, IQ, socio-communication profile score (SRS-2) and presence comorbidities (TADH, TDC).

Eligibility Criteria:
Inclusion Criteria :

All participants :

* Be between 6 and 11 years old
* Mastery of the French language
* Be affiliated with a Social Security scheme or benefit from affiliation by a third person
* Both parents (or the holder of legal authority) have read, understood and signed the study consent
* Be affiliated with social security

Participants with ASD should also verify the following inclusion criteria:

* Being diagnosed with ASD (DSM-V)

Exclusion Criteria :

All participants :

* Refusal to participate in the research on the part of the participant and / or holders of parental authority.
* Be a person benefiting from enhanced protection, namely : persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment.
* Have uncorrected visual or hearing problems
* To have concomitant psychotropic drug treatments not stabilized, initiated in the last 2 months: antipsychotics, mood stabilizers, anti-epileptics, psychostimulants, antidepressants.
* Have a motor handicap of the upper or lower limbs, fitted or not.
* Have diagnosed neurological or psychiatric disorders, present a general or metabolic pathology having a known impact on the child's motor skills (eg: Epilepsy, Tics and Gilles de la Tourette Syndrome, Intellectual Deficiency, Neuromuscular Syndrome, Metabolic Neurological Syndrome , neoplasms)
* Suspicion of low intellectual efficiency if at least one of the two subtests (Similarities or Matrices) of WISC V (retrieved from the medical file if the TSA participant) presents a result (standard score) strictly lower than 7.

Participants without ASD :

* Participant with ADHD (Attention Deficit Disorder with or without Hyperactivity) or CDD (Developmental Coordination Disorder)
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 1, 2, 3, or 6 HCV infection
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation

In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. This single-centre study conduced at the Nancy Maternity Hospital is based on a retrospective cohort of all patients who underwent a medical termination of pregnancy between January 2010 and October 2021. The main objective is to evaluate the complications according to the term of the termination of pregnancy between two groups : \[12-14\] vs \[14-16\] weeks of gestation. The secondary objective is the distribution of these complications between the two groups. Pregnancy termination can be performed in two methods, either by medical method with mifepristone and misoprostol, or by surgical method by dilation and evacuation. Complications identified are haemorrhage, infection, retained product of trophoblast, uterine rupture and abortion induction failure. The hypothesis is the concomitant increase in complications with the term of the termination of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* termination of pregnancy for a medical reason
* between 12 and 16 weeks of gestation
* singleton pregnancy

Exclusion Criteria:

* multiple pregnancy
* abortion occurred before the induction of termination of pregnancy
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetic peripheral neuropathy
* Moderate to severe neuropathic pain

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)

The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in order to determine its policy value and to guide efforts to improve maternal and infant health outcomes nationally. In addition, the study includes a large randomized evaluation of performance-based incentive payments to providers to improve quality of medical care provided during delivery and actual health improvement in the providers' patient populations and their catchment areas.

The evaluation study will first provide new evidence on the effectiveness of demand-side strategies to increase institutional deliveries and improve childbirth outcomes. Second, the study will analyze one of the first implementations of direct rewards to providers for health improvement in a developing country. Third, the study will provide critical new insight into dynamics between demand and supply-side incentives in improving population health outcomes as either complements or substitutes.

The study uses household survey to collect data from mothers on socio-economic, human capital, quality of life variables (including below poverty line \[BPL\] index components) and as well as information about deliveries, fertility histories, morbidity and mortality (for mothers, infants, and children), birth related complications, health service use and spending. Additionally, provider surveys will collect data on infrastructure, staffing, provider qualifications, provider knowledge and process measures of provider performance.

Eligibility Criteria:
Inclusion Criteria:

* Households with new mothers (one to three weeks after childbirth)
* Rural private sector maternity care providers who are listed on the Karnataka government's legitimate provider list.

Exclusion Criteria:

* Households without children
* Households where mothers gave birth \> 3 weeks ago
* Public sector maternity care providers
* Private sector maternity care providers serving in towns with large public providers such as Community Health Centers (CHCs)
AI-powered Portable MRI Abnormality Detection

This study aims to test a new AI-powered portable MRI scanner that can quickly identify whether a brain scan is normal or abnormal. Currently, standard MRI scans are expensive and have long waiting times. Our goal is to see if a smaller, cheaper, and more accessible MRI scanner-combined with artificial intelligence (AI)-can help doctors identify abnormalities faster and improve patient care.

We will invite patients from King's College Hospital (KCH) who are already having a standard MRI scan. They will be asked to have an extra scan using the portable MRI, which takes about 60 minutes. The AI tool will then analyse these scans and compare its results to those of expert radiologists.

By the end of the study, we hope to prove whether portable MRI with AI can be used in hospitals and GP clinics, making brain scans more accessible, reducing wait times, and helping doctors prioritise urgent cases.

This study is funded by the Medical Research Council (MRC) and has been approved by UK research ethics committees.


Eligibility Criteria:
Inclusion Criteria:

Adults ≥18 years old. Undergoing standard brain MRI including T2-weighted sequences.

Exclusion Criteria:

Contraindications to MRI (e.g. pacemaker, pregnancy). Poor quality MRI scans without a neuroradiology report.
Medical Abortion With Single Daily Dose of Misoprostol

Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age less than 13 weeks.
* Hemoglobin \>10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Missed abortion.
* Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age more than 12 weeks.
* Hemoglobin \<10 g/dL.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25kg/m2 and more than 35kg/m2.
* Coagulopathy.
* History or evidence of adrenal pathology.
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Cell Salvage During Caesarean Section (CSCS)

The purposes of this study are:

1. To compare the difference of blood loss of the patients undergoing cesarean section between intraoperative blood recovery and allogeneic blood transfusion.
2. To compare the safety of the two methods.
3. To evaluate the medical cost and the overall cost of the two methods.

Preoperative: 1.To select patients according to the criteria.2.To obtain the consent of the obstetrician, the anesthesiologist, and the patients.

Intraoperative:According to local blood transfusion guidelines, obstetric advice, anesthesia advice(tentative: before a blood transfusion maternal's Hb less than 70g/L or Hb:70-100g/l before a blood transfusion according to the blood transfusion program and doctor's determine to do the blood transfusion),those who need blood transfusion during cesarean section will be randomly assigned to the following two groups:

1. cesarean section using intraoperative blood recovery group (test group).
2. cesarean section using allogeneic blood transfusion group (control group).

The theoretical amount of blood transfusion should be based on the following formula:

The amount of blood transfusion needed (ML) \* Hb= (Hb2-Hb1) \* blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg \* body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the test group or the control group.

Postoperative: Calculate the amount of bleeding in the subjects and other related indicators.

Follow up: maternal pregnancy again: detection of maternal blood group antibody IgG titer, hemolytic disease of the newborn Statistical data: the specially assigned person is responsible for the data collection. And the data is entryed by two times (the first phase: hospitalization period, the second phase: follow-up), which is by the inspectors to verify the authenticity and traceability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Delivery by elective or emergency caesarean section with an identifiable increased risk of haemorrhage.
* Ability to provide informed consent
* Participants need blood transfusion

Exclusion Criteria:

* Hb\<70g/L before operation
* Participants have a history of blood transfusion
* Blood type is RH blood type
* Sickle cell disease
* The obstetricians and anesthesia doctors think some cases existing intraoperatie blood recycling contraindications
* PT and APTT is 1.5 times longer than normal and above, or platelet is less than 50 \* 109 / L preoperative
* Cultural or social beliefs contraindicating blood transfusion.
* Significant antibodies making it difficult to find cross matched blood for transfusion
* participation in another clinical trial within 3 months prior to selection
* ability to provide informed consent
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis

Purpose：To observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE).

Methods and Materials：A total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. In the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. The clinical efficacy of deep-sea fish oil on prevention of ARIE was evaluated by comparing the differences in the occurrence time, the grade and incidence of ARIE. Additionally, the change in nutritional status was also investigated. Hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.

Radiotherapy is an important treatment for esophageal cancer, and acute radiation-induced esophagitis (ARIE) is the most common complication during radiotherapy. The present study was conducted to investigate the clinical efficacy of deep-sea fish oil in the prevention and treatment of ARIE, and to evaluate the effects of deep-sea fish oil on patients' nutritional status, quality of life, pain management, and the effect on the treatment. This is a prospective, single-center, randomized controlled clinical study. The present study has been registered in the Chinese Clinical Trials Registry (ChiCTR2200056847). The present study intends to continuously enroll 120 patients with esophageal cancer who are to receive radiotherapy, and randomly divide the enrolled patients into two groups. One group receive treatment of deep-sea fish oil and the other group is blank control. The differences of ARIE occurrence, ARIE degree, pain degree, and the changes of the inflammatory index were compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, ≤70 years old, gender is not limited;
2. Histological or cytological evidence of esophageal, lung, or breast cancer;
3. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
4. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
5. PG-SGA score \<9;
6. Not pregnant or breastfeeding;
7. The subject must understand and sign the informed consent
8. Have reading comprehension ability and can complete the questionnaire with medical assistance;
9. Those who voluntarily participate in the study and sign the informed consent letter in person.

Exclusion Criteria:

1. Prior radiation therapy;
2. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
3. Pregnant or lactating female patients;
4. Suffering from severe mental illness and poor compliance;
5. Other cases deemed unsuitable for inclusion by the researchers.