cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women

This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength.

In addition, it will examines the association between PFM function, and anxiety.

This cross-sectional study will include women with symptoms of hip-related pain persisting \> three months(research group), and women without hip pain (control group). A single session will include various assessments as follows: abdominal ultrasound examination to evaluate PFM function and endurance, in addition, each participant will evaluate her ability to perform correct contraction of PFM, hand-held dynamometer testing for hip rotator muscle strength, the International Consultation on Incontinence Questionnaire (ICIQ) for evaluating symptoms and impact of urinary incontinence, the International Hip Outcome Tool 12 for assessing hip function and pain, the Hospital Anxiety \& Depression Scale (HADS), and a functional performance task involving the hip muscles - a single-leg squat.

Eligibility Criteria:
Inclusion Criteria for Research Group:

* complaints of hip related pain,
* Visual Analog Scale (VAS) \>3 for three months,
* with one or more of the symptoms relevant to the syndrome - (1) hip or groin pain produced by a certain movement or position, stiffness and limitation of movement or clicks from the hip joint, (2) examination A positive FADIR performed by the researcher before conducting the study

Exclusion criteria:

* the presence of additional diagnoses of the slipped capital femoral epiphysis,
* Perthes disease,
* avascular necrosis, and osteoarthritis-Calve-Legg,
* neurological or Metabolism,
* surgery/fracture in the hip joint of which the woman complains,
* pregnancy or childbirth in the last year,
* Treatment of the pelvic floor in the last year.

control group - health women without any pain or symptoms in the spine and lower extremities
Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery

Amisulpride is a potent antagonist of dopamine D2 and D3 receptors, both implicated in the emetic response when activated. It is currently used intravenously for the prevention of chemotherapy-induced and postoperative nausea and vomiting (PONV), but this route has a short half-life time of 4 to 5 hours, could be expensive, causes infusion-related pain, and is not available in Brazil. Some of these limitations could be overcome by the preemptive use of an oral formulation. At present, there are no data regarding the use of oral amisulpride for PONV, which is an affordable and painless option with half-life time of 12 hours. We propose a quadruple-blind clinical trial involving patients undergoing gynecological surgery aged 18 years and older, and assessed as being at high risk for PONV according to the Apfel Score (score 3 or 4). The primary outcome of this study is to evaluate complete response to PONV up to 24h, comparing the efficacy of adding 50 mg oral amisulpride as a third antiemetic agent to the standard institutional protocol at the Hospital da Mulher of São Paulo (IV dexamethasone 10 mg + IV ondansetron 4 mg) for laparoscopic surgeries. Secondary outcomes will evaluate (1) nausea, (2) vomiting, (3) nausea and vomiting, (4) use of rescue treatment, (5) overall adverse events, and (6) adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic hysterectomy to treat benign conditions.
* High risk for PONV according to the Apfel Score: scores 3 or 4.
* American Society of Anesthesiology (ASA) physical status: 1 or 2.

Exclusion Criteria:

* Cognitive or psychiatric conditions impairing consent or compliance.
* Incapability of using the mobile app MyCapp for data collection.
* History of allergy or sensibility to any medication included in the protocol: amisulpride, dexamethasone, ondansetron, fentanyl, midazolam, bupivacaine, morphine, propofol, rocuronium, sevoflurane, ephedrine, metaraminol, remifentanil, metamizole, ketoprofen, sugammadex, dimenhydrinate, pyridoxine hydrochloride, tramadol, dimethicone.
* Inability to swallow medications.
* Current use of typical or atypical antipsychotic medications.
* Gestation or lactation.
* Clinically significant cardiac arrhythmia or long QT syndrome documented.
* Hypokalemia (K+ \< 3.5 mmol/L)
* Prolactin-dependent tumors.
* Pheochromocytoma.
* Parkinson's disease.
* Nausea or vomiting in the 24 hours before surgery.
* Therapeutic use of antiemetics, including corticosteroids.
* Emetogenic oncological therapy (above 10% probability of causing vomiting) in the 2 weeks before surgery.
* Persistent pre-operative hypotension on the day of surgery, defined as systolic blood pressure \< 100 mmHg on at least 2 consecutive measurements.
* Mechanical ventilation plan or need for a naso/orogastric tube after surgery.
* Intestinal endometriosis
Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia

The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.


Eligibility Criteria:
Inclusion Criteria:

* Chronic schizophrenia
* Serum 25(OH)D level below 30 ng/ml
* Deficit in cognitive functions

Exclusion Criteria:

* Hypercalcemia
* Hepatic or renal failure
* Obese
* Metabolic syndrome
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.

The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .

Eligibility Criteria:
Inclusion Criteria:

* Patients in the age group 20 to 80 years
* A cytological or histological diagnosis of inoperable PDAC based on multidisciplinary review of cross sectional imaging and cytology or histology results.
* Patients who have been deemed unfit for surgical resection of the PDAC subjects who are fit for surgical resection but have declined surgery will also be considered for the study
* PDAC patients presenting with jaundice to be considered after a successful biliary drainage
* Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2)
* Patients capable of giving informed consent

Exclusion Criteria:

* Inability to give informed consent
* Pregnancy or breast feeding
* ECOG performance status 3 or 4
* Life expectancy less than 3 months
* Patients with distant metastases or malignant ascites
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients

To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).

To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:

* residual plasma replication between 0 and 50 copies/ml
* intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
* proviral HIV DNA levels in PBMC and RL.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged over 18 years
* HIV infection confirmed by Western Blot
* Karnofsky score \> 80%
* Treatment-experienced patients having received combined antiretroviral therapy including at least 2 RTI and 1 PI/r for at least 12 months with plasma viral load \<50 copies/ml for at least 6 months
* Stable first-line treatment (or other, if changes were not made for reasons relating to viral resistance) with 2 RTIs and 1 PI/r
* Proper safety and compliance for the ongoing combination;
* Patient agreeing to undergo 3 proctosigmoidoscopy examinations over a 12-month period;
* Plasma HIV-1 RNA \<50 copies/ml at inclusion;
* Circulating CD4 \>200/mm3 at inclusion;
* Isentress® and Celsentri®-naïve patients
* No contraindications to the use of the investigational products
* Written, informed consent, obtained from the patient or his/her legal representative.

Exclusion Criteria:

1. Opportunistic infection or active tumor disease
2. Chronic diarrhea, malabsorption, progressive enteric infection
3. Aged under 18 years
4. Pregnancy - breast-feeding ( a pregnancy test will be done at the inclusion visit)
5. Co-infection with HIV-2
6. History of immunomodulator treatment (interleukin-2, alpha-interferon)
7. Ongoing treatment of HBV or HCV co-infection
8. Blood constitution disorders
9. Contraindications to the administration of raltegravir or maraviroc
10. Circulating CD4 nadir \<100/mm3 in the natural history of HIV-1 infection.
Computerized Feedback in Colonoscopy

In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort.

Background:

Approximately 4,600 persons get colon cancer annually in Denmark and it is the second most common cause of cancer death. Survival is highly dependent on early detection through a colonoscopy. A thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. A study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (ADR) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. The investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS)

Objectives:

The investigators predict that live-feedback from CoPS and CoRS doing a colonoscopy can improve the ADR and subsequent prevent colorectal cancer. The aim of this project is to:

1. In a cluster-randomized study compare if feedback from CoPS and CoRS can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole.
2. Make an immediate measure to assess the quality of individual colonoscopy performance.

Materials and methodology:

As a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (CoPS and CoRS) will be tested compared to no feedback. Three test departments consisting of three University Hospital in the Capital region of Denmark will be included.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.

Exclusion Criteria: Incomplete procedure due to:

* In cases were the cecum is not reached.
* Unsatisfactory bowel preparation which results in admission for a new procedure
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

This is a dose escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others.
* Phase 1a: Received prior therapy for their condition (if available) and should be refractory to or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
* Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types.
* Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease.
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
* Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
* Adequate organ function without symptomatic visceral disease.

Exclusion Criteria:

* Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available).
* Known leptomeningeal disease or uncontrolled, untreated brain metastases.
* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
* History of hepatitis B or active hepatitis C infection.
* Prior allogeneic stem cell transplantation, or organ transplantation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia

This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.

This study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. The effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. However, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. The investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.

Eligibility Criteria:
Inclusion Criteria:

* adult patients receiving total-knee arthroplasty under spinal anesthesia
* ASA class 1-3

Exclusion Criteria:

* infection at the needle injection site
* hard for pain evaluation
* CRPS patient with lower extremity symptom
* chronic opioid user
* those with side effect to local anesthetics
* those getting revision total-knee arthroplasty or with the previous operation at the same knee area
* those getting the surgery under general anesthesia due to the failed spinal anesthesia
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study

This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients \> 18 years old recently diagnosed of pancreatic cancer (\<3 months).
* 2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
* 3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria:

* 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
* 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) \< 60mL/min should be excluded.
* 3. Patients treated with anticonvulsants during the previous 4 months.
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).


Eligibility Criteria:
Inclusion Criteria:

* Age Limits (18-80 years)
* Information and non-opposition for participating in the study
* Patients suffering from periodontitis grade III ou IV
* Patients suffering from microcristalline arthritis
* patient with health insurance

Exclusion Criteria:

* patient under corticotherapy
* pregnancy
* non-compliant patient
* patient with no health insurance
* patient in exclusion period from an other study
* legal incapacity
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.

The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. The hypothesis is that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, the investigators plan to perform detailed pharmacokinetic and pharmacodynamic studies of ulipristal acetate-based EC in obese women and expand upon the preliminary findings of levonorgestrel-based EC. This protocol registration is for the LNG aspect of the study procedures focused on the pharmacodynamics of LNG dose escalation

Eligibility Criteria:
Inclusion Criteria:

* Generally health women
* Aged 18-35 years old
* Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.
* Subjects must have a BMI of \>30 kg/m2 and weigh at least 80 kg or more.

Exclusion Criteria:

* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
* Impaired liver or renal function
* Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
* Recent (within last 8 weeks) use of hormonal contraception
* Current use of drugs that interfere with metabolism of sex steroids
* Smokers.
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).


Eligibility Criteria:
Key Inclusion Criteria:

* Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
* Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
* It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study

Key Exclusion Criteria:

* Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
* Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
* Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;