cyrilzakka/clinical-trials huggingface dataset:
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management

This study compared the efficacy and safety of superior hypogastric plexus block and ganglion impar block procedures on the management of pelvic and perineal cancer pain in patients with cervical and endometrial cancer

Superior hypogastric plexus block is a commonly used method for the management of pelvic and perineal pain due to cancer, this procedure uses a transdiscal approach at the level of the L5-S1 vertebrae by injecting 5 ml of 1% lidocaine + 10 ml of 96% alcohol and confirmed by C-arm.

Compared with the ganglion impar block procedure using a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by C-arm. The aim of this study was to compare the efficacy and safety of the ganglion impar block procedure against the superior hypogastric plexus block which is commonly used in the management of pelvic and perineal pain due to cervical and endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Unbearable cancer pain that is resistant to WHO (World Health Organization) pain ladder at least 2 weeks medication
* The patient is tired of taking medication orally or complications of current medication (respiratory depression, nausea, vomiting, opioid-induced constipation, gastrointestinal disturbances)
* Patients with pelvic floor pain diagnosed by a (Fellow of Interventional Pain Practice) FIPP-certified pain specialist
* Patients with pain in the perineum diagnosed by a FIPP-certified pain specialist
* Numerical Rating Scale \>4
* \>18 years old
* Able and willing to sign an informed consent

Exclusion Criteria:

* Refuse to be included in the research
* Blood clotting disorders (including taking anticoagulant drugs)
* Local infection in the area of action
* Loss to follow up

Drop-out Criteria:

* Loss to follow up
* Intervention complications occur
* Failed intervention
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (\~75% in USA and Canada) and toward LB NT in South America (\~80% in Argentina and Mexico). In Europe the trend is equal (\~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.

Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications


Eligibility Criteria:
Inclusion Criteria:

1. Staghorn calculi
2. Renal pelvis stones =\>2 cm
3. Lower pole stones= \>1.5 cm
4. upper ureteral calculi =\>1.5 cm
5. SWL-resistant stones

Exclusion Criteria:

1. Age \<18 years or Pregnancy
2. Tubeless PNL
3. Need for 3 percutaneous tracts intraoperative
4. Morbid obesity (BMI \>40)
5. Refuse to complete study requirements
6. Tumour in the presumptive access tract area or Potential malignant kidney tumour
A Study to Evaluate the Safety of Augment™ Bone Graft

Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?

Subjects will be 18 to 40 years with an osteochondral defects of the knee.They will be candidates for allograft and Augment Bone Graft will be added to the procedure. The safety of Augment Bone Graft plus allograft for osteochondral defects of the knee will be evaluated by type, frequency, severity and relatedness of adverse events to the device for a minimum of 24 weeks.Magnetic Resonance Imaging will be performed at 1,12 and 42 weeks to evaluate device integrity and surgical treatment of osteochondral defects. Computed tomography will be done at week 1 and week 24 to determine the healing status of the osteochondral defect.

Eligibility Criteria:
Inclusion Criteria:

* Prior Magnetic Resonance Imaging (MRI) evaluation or MRI on Screening.
* Subjects with Grade III osteochondral defect (OCD) of femoral condyle.
* Subjects with OCD \> 1 cm.squared.
* Independent and ambulatory pts.
* Subjects from 18 to 40 years of age.
* Subject with a stable knee joint and similar stability on the opposite knee.
* Subject has knee x-ray with \< 15 degrees of valgus and \< 5 degrees varus.
* No deformity from previous fractures of tibia or fibula.
* BMI \< 35.
* Subject has an American Association of Anaesthetists physical status classification of 1 or 2.
* Subject must present with pain \> 3.0 cm according to the Visual Analogue Score.
* Subject has exhausted non operative treatment.

Exclusion:

* Allergy to yeast derived products.
* Index knee has had cartilage repair in the last six months.
* Subjects with osteoarthritis,inflammatory arthritis, rheumatoid arthritis and avascular necrosis of index knee.
* Subject has contralateral knee complications which would interfere with rehabilitation
* Subject has implanted metallic devices that would prevent Magnetic Resonance Imaging (MRI).
* Subject has claustrophobia that would prevent MRI.
* Subject has had a malignancy or is being treated for a malignancy.
* Subject is physically or mentally compromised that would interfere with compliance.
* Subject is a prisoner or transient.
* Subject has a recent history (12 months) of alcohol abuse.
* Subject is pregnant, able to become pregnant but not practising birth control.
* Subject has an infection in the operative area.
* Subject has scheduled surgery on the contralateral knee over the course of the study.
* Subject requires another procedure in the index knee.
* Subject has had steroid therapy in the past six months.
* Subject is taking prescription pain medication for another indication other than the index knee.
* Subject is using nicotine in any form.
Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions

The aim of this study was to examine the effectiveness of two video-based multicomponent programs: Fibrowalk Virtual and the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only.

The investigators posit that Fibrowalk Virtual plus face-to-face sessions, due to the best results obtained with the Fibrowalk carried out completely face-to-face versus the results of the Fibrowalk Virtual, can help patients with FM to experience more ubiquitous clinical improvement than TAU or Fibrowalk Virtual alone.

Fibrowalk therapy has shown better results when performed in a natural environment face-to-face. Due to the state of the pandemic, it is necessary to study different forms of approach. It is proposed what number of face-to-face sessions would be necessary to add to the virtual Fibrowalk program to achieve the same or similar effectiveness as in the totally face-to-face format.

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatmentas- usual (TAU) vs. TAU alone and on the comparation of the FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK.

* VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
* FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy.
* The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced NSCLC.
* Stage III with pleural effusion and stage IV.
* Patients are 70 years old.
* Patients with 1 \> ECOG PS =1.
* Patients must have at least one measurable lesion, no previously irradiated.
* Life expectancy of at least 12 weeks.
* Adequate organ function according to the following criteria:

  * Bone marrow: ANC \>= 2.0x10(9)cells/L; Platelet count \>= 100x10(9)cells/L; Leukocyte count \>= 4000x10(6)/L; Hemoglobin \>= 10 g/dL.
  * Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN;AST and ALT \<= 1.5 x ULN.
  * Renal function: serum creatinine \<= 2mg/dL.

Exclusion Criteria:

* Prior systemic chemotherapy for advanced disease.
* Patients with symptomatic brain metastases.
* No measurable bone metastases or malignant pleural effusion as only measurable lesion.
* History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
* History of hypersensitivity reaction to study drugs.
* Concurrent treatment with other experimental drugs.
* Current peripheral neuropathy NCI grade 2.
* Participation in clinical trials within 30 days of study entry.
* Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin in treating patients who have recurrent or refractory Hodgkin's disease.

OBJECTIVES: I. Determine the response rate, failure free survival, and progression free survival of patients with recurrent or refractory Hodgkin's disease treated with tretinoin liposome. II. Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior response to treatment (refractory vs recurrent vs post marrow transplant). Patients receive tretinoin liposome IV over 30 minutes every other day for 28 days. Treatment continues every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are eligible for stem cell or marrow transplant receive at least 2 courses before crossing over to transplant. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 105 patients (35 per strata) will be accrued for this study over 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory Hodgkin's disease Recurrent after partial or complete response after initial therapy OR Refractory after no response or progression after initial therapy At least 2 prior treatment regimens (radiotherapy considered separate if not part of planned combined modality) Bidimensionally measurable disease No active CNS disease

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3 Platelet count at least 20,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT less than 4 times upper limit of normal Renal: Creatinine no greater than 3.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Must not be eligible or willing to undergo treatment of a higher priority HIV negative No other prior malignancies within the last 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix treated with curative intent No other concurrent serious illness or active infection No mental or social reasons that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior autologous stem cell or marrow transplant No prior allogenic stem cell or marrow transplant Chemotherapy: See Disease Characteristics Must be recovered from last regimen No prior retinoids, including tretinoin Endocrine therapy: No concurrent steroids Radiotherapy: See Disease Characteristics Must be recovered from last regimen Surgery: Not specified
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida

This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool. Infants who have Candida in their stool are eligible to participate. Half of the enrolled infants will have additional MCT oil added to their feedings and half will not.


Eligibility Criteria:
Inclusion Criteria:

* Premature infant admitted to the Neonatal Intensive Care Unit at Women \& Infants Hospital
* Receiving full enteral feeds of either preterm or transitional formula or fortified breast milk
* Anticipated to have a minimum stay of two weeks

Exclusion Criteria:

* Prior exposure to antifungal drugs
Controlling And Lowering Blood Pressure With the MobiusHDTM Device

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years;
* Diagnosed with resistant hypertension;
* A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
* A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy
* Treatable cause of resistant hypertension
* Hypertension secondary to an identifiable and treatable cause other than sleep apnea
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa

The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.

Exclusion Criteria:

* Participants previously treated with Humira.
* Participants who do not provide consent.
Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

The purpose of this study is to increase our understanding of infertility in women with Rheumatoid Arthritis (RA). In this study the study team will compare the differences in ovarian reserve (the ability to provide egg cells that are capable of fertilization), the frequency of ovulation and the number of pregnancies between women with and without RA. It is possible that RA activity and medications limit ovarian reserve and ovulation, which may increase infertility among women with RA. There are several suspected causes for infertility in RA, including age-related fertility decline, inflammatory changes that impact endometrial receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis medications and increased frequency of anovulation (a menstrual cycle during which ovaries do not release an egg) due to RA activity.

This study is the first step toward our long term goal of increasing the ability of all women with RA to build the family they desire.


Eligibility Criteria:
Inclusion Criteria:

1. RA cohort: Women diagnosed with RA (2010 ACR/EULAR criteria) at least one year prior to enrollment
2. Healthy cohort: Women without autoimmune disease

Exclusion Criteria:

1. Unilateral or bilateral ovarian surgery
2. Prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)
* Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
* ECOG Performance Status: 0-1

Exclusion Criteria:

* Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
* Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
* Known mismatch repair deficiency or microsatellite instability-high disease
* Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
* Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator
* Any of the following baseline laboratory abnormalities:

  * Absolute neutrophil count (ANC) \< 2,500/mm3
  * Platelet count \< 100,000/mm3
  * Hemoglobin \< 9 g/dL
  * Creatinine \> 1.5 x ULN
  * Total bilirubin \> 1.5 x ULN
  * AST/ALT \> 5 x ULN
  * Patients who are unable to provide informed consent
  * Patients who are pregnant or breastfeeding
  * Patients who are incarcerated, homeless, or have active substance use disorders
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version \[SCID-5-CT\], with symptoms that have been present for at least a 4-week period.
2. Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.
4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.

Exclusion Criteria:

1. Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
2. Participant has onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period.
3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m\^2 at Screening, which is subject to a broader evaluation of medical comorbidities.
4. Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment.
5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.
7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.