cyrilzakka/clinical-trials huggingface dataset:
Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

A prospective, interventional, monocentric, controlled and randomized study will compare a conventional surgical technique to a surgical technique with the assistance of the Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).

Background: The Acetabular Cup Orientation Guide(ACOG) System from MATERIALISE NV was developed and is intended to be used as a surgical instrument to assist in the positioning of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative computed tomography (CT) imaging scans.

Use of ACOG is a relative new technique. ACOG, based on CT imaging data, fit directly into the patient's anatomy and enable primary total hip replacement . Data showing extra benefit of this technique compared to conventional THR technique are not widely available.

Aim: To determine the safety of this new surgical technique compared to conventional THR.

Methods: 30 participants will be randomized to 2 groups. One group will be operated for a THR with the conventional technique and the other group will be operated for a THR with the assistance of the ACOG System. CT imaging will be taken pre and post operatively to measure cup orientation.

Eligibility Criteria:
Inclusion Criteria:

* Is selected to undergo a primary THR
* Informed consent

Exclusion Criteria:

* Is unable to undergo CT imaging of the full pelvis
* Requires surgical treatment within less than 4 weeks of initiation
* Is unable to undergo a THR through a anterolateral approach
* Presents acute/chronic local or systemic infection
* Is allergic to polyamide
* Patient's BMI \> 35
* Patients with severe wear of the acetabular rim or other disorders that affect acetabular rim anatomy and bony landmark recognition.Patients exhibiting severe wear.
* Has impaired decision-making capacity
* Is a prisoner
* Is pregnant
* Has metal components that will result in scatter on the CT imaging
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Onset of seizures in the first year of life
* History of fever-induced prolonged seizures as determined by the Investigator
* These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
* Multiple seizure types which may include:

  * generalised tonic-clonic (required for inclusion)
  * clonic (required for inclusion)
  * myoclonic jerks/seizures
  * history of normal development prior to seizure onset followed by development delay or regression after seizure onset
  * abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) \[Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED\] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

Exclusion Criteria:

1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
2. The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
3. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids
4. The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed
5. The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy

Other protocol-defined inclusion and exclusion criteria may apply.
V+PSF-M for Tobacco Cessation in HIV Care in India

The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).

The study interventions used in this research study are:

* Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program)
* Varenicline (or Chantix, apovarenicline, Champix or Nocrav)

Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.

Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities

In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.

Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.

Participation in this study is expected to last about 24 weeks.

It is expected about 400 people will take part in this research study.

This study is funded by the National Cancer Institute of the National Institute of Health (NIH).

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Confirmed HIV diagnosis
* Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test
* Able to read at 6th grade level or greater and speak Tamil, Telugu or English
* Able to use varenicline safely based on evaluation by primary provider at VHS
* Women of childbearing potential who consent to use a medically approved method of contraception or abstain from intercourse while taking study medication and for one month after.
* Ready to quit or interested in quitting

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 6 months
* Breastfeeding
* Myocardial infarction in past 30 days or unstable angina
* History of liver or kidney failure
* Alanine aminotransferase and Aspartate aminotransferase \> 2 times upper limit of normal or creatinine clearance \<50 in past 6 months
* History of suicide attempt
* Current suicidal ideation
* Untreated or unstable major depressive disorder
* History of psychosis or on anti-psychotic medications
* Cognitive impairment limiting ability to consent
* Allergy to varenicline
CHOCOlate MeLatonin for AdolescenT MigrainE

Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.

This pilot randomized trial is a dose-finding study to determine which dose of melatonin is most effective for treating acute migraine in children and adolescents who have episodic migraine. Investigator will identify the most effective dose to pull forward into a future fully-powered placebo-controlled efficacy study. If both doses are equally effective, Investigator will bring forward the best tolerated dose. If doses are equally well tolerated, Investigator will bring forward the lowest effective dose, as this will minimize cost to families should this treatment become widely adopted.

Eligibility Criteria:
Inclusion Criteria:

1. Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
2. Age 3-17 years
3. Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
4. If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

Exclusion Criteria:

1. Allergy or intolerance to melatonin, or to chocolate.
2. Opioid or barbiturate overuse as defined in ICHD
3. Pregnant/lactating
Hand Function in Patients With Poly- or Dermatomyositis

The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life.

The study is a cross-sectional study. To assess hand function the investigators will measure grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance will be measured with Myositis Activities Profile and health related quality of life will be assessed with SF-36.

The investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with definite or probable polymyositis or dermatomyositis (according to criteria by Bohan and Peter) were included in the study

Exclusion Criteria:

* Other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
* Operable, age-related cataract eligible for phacoemulsification.

Exclusion Criteria:

* Closed Angle and narrow angle forms of Glaucoma.
* Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.
Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)

This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.

The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency.

The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Eligibility Criteria:
Inclusion Criteria:

- Consent in the documentation of clinical and radiological results

Exclusion Criteria:

- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
Community-Based Interventions for Infant Health in Nepal

An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy


Eligibility Criteria:
Inclusion Criteria:

* mothers, community health volunteers

Exclusion Criteria:

* none
A Clinical Study Comparing the Effectiveness and Safety of Three Surgical Pathways for Laparoscopic Total Hysterectomy

To explore the achievement of ERAS composite indexes within 24 hours after the operation of transumbilical single-hole laparoscopic total hysterectomy, transvaginal laparoscopic total hysterectomy and porous laparoscopic total hysterectomy.

To explore the achievement of ERAS composite indexes within 24 hours after the operation of transumbilical single-hole laparoscopic total hysterectomy, transvaginal laparoscopic total hysterectomy and porous laparoscopic total hysterectomy.To explore the differences of operation time, intraoperative blood loss, intraoperative conversion mode and postoperative complication rate of three surgical paths: transumbilical single-hole laparoscopic total hysterectomy, transcolposcopic total hysterectomy and porous laparoscopic total hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 females
* Total hysterectomy indications (uterine fibroids, adenomyosis, cervical precancerous lesions, endometrial dysplasia, cervical carcinoma in situ), total hysterectomy is planned
* The patients who participated in the study recognized three surgical paths and were willing to accept any of the three at random
* Be able to understand the research program and voluntarily participate in the research, and sign the informed consent
* Good compliance, able to cooperate with and provide corresponding clinical information
* Complete imaging and pathological clinical data;
* General condition: ECOG≤1; 0 The activity capacity is completely normal, and there is no difference between the activity capacity and that before the onset of the disease; 1 Can move about freely and engage in light physical activity, including general household or office work, but cannot engage in heavy physical activity.

Exclusion Criteria:

* asexual life history
* The cyst needs to be removed at the same time or there are other vulvar, vaginal, appendix and other lesions, and surgical intervention is required at the same time
* Malignant tumors or highly suspected malignant tumors
* History of two or more pelvic surgeries, severe pelvic adhesions(triad examination suspected rectal endometriosis, or poor intrauterine mobility)
* History of peritoneal dialysis, pelvic radiotherapy, and previous history of pelvic laparoscopic tuberculosis
* the uterus is greater than 3 months of pregnancy or the maximum meridian of the uterus is greater than 12cm according to ultrasound (either of the two conditions can be excluded)
* Diabetic patients with unsatisfactory blood sugar control
* BMI\>30Kg/m2
* History of severe mental illness and brain dysfunction
* A history of drug abuse or use
* Patients with poor compliance or who are too far away for adequate follow-up
Improved Preoperative Selection of Cold Thyroid Nodules

Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle aspiration cytology can improve the selection of patients with benign versus malignant thyroid nodules with improved sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Solitary thyroid nodules that appear solid on ultrasound and cold on a scintiscan

Exclusion Criteria:

* Pregnancy and lactation
* Age below 20 years
Retrospective Study of Psychoattitudinal Patterns in Patients With Fibromyalgia Receiving Antalgic Therapy

Fibromyalgia (FM) is a widespread and invalidating disease that requires a multidisciplinary approach. Particularly, the psychiatric component seems to influence the algological management of these patients. Since January 2018, the HADS, SF-36, IMSA, TCI psycho-attitudinal questionnaires have been introduced in the Pain Therapy unit of Policlinico Sant'Orsola-Malpighi in an attempt to improve the care of patients diagnosed with FM.

The aim of the study is to identify, through retrospective evaluation of TCI tests and its subdomains, compiled by patients with FM diagnosis, Pain Avoidance and Pain Persistance personality patterns, indicated in the literature. Anxiety and Depression incidence is also observed through retrospective evaluation of HADS tests.

Patients in the Antalgic Therapy Outpatient Clinic diagnosed with FM, aged ≥18 years, who have completed selfadministered psychoattitudinal tests from January 2018 to January 2019 were considered. The data were collected in aggregate and extrapolated anonymously.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia
* years ≥ 18

Exclusion Criteria:

* not present
PD1-CD19-CART in Patients With r/r B-cell Lymphoma

This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.

PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years post T cell infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Have the capacity to give informed consent;
2. ALL patients with the age between 18 and 70 years old;
3. Expected survival \>3 moths;
4. With no severe heart and lung disease;
5. Previously confirmed diagnosis as CD19+ NHL within 6 months;
6. Hematological index as following, white blood cell (WBC)≥1.5×10\^9/L，absolute neutrophil count (ANC) ≥0.8×10\^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10\^9/L；
7. Blood biochemical index as no more than 1.5\* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5\* ULN in patients with tumor metastasis in liver and kidney;
8. With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
9. Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test is acceptable if HBsAg is positive;
10. ECOG \<2;
11. Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after \> 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.

Exclusion Criteria:

1. Pregnant or lactating women;
2. With a pregnancy plan in the next 2 years;
3. Prior treatment of anti-GVHD therapy;
4. Acceptance of allogeneic stem cell transplant (ASCT);
5. Isolated extramedullary relapse of ALL;
6. Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
7. Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment;
8. History of other type of maligant tumors;
9. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.
Enhanced Recovery After Surgery for Emergency Caesarean Deliveries

Caesarean section (CS) constitutes a large proportion of the total surgical volume in low-income countries. This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations and high costs. These have led to the adoption of ERAS in developed countries in a bid to save costs by reducing hospital length of stay without compromising the health of the mother and her baby.

CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations. Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages. ERAS has been seen to reduce duration of hospital stay, complications and costs. Although many of the elements of enhanced recovery after surgery are similar, it has not been tested in emergency CS and there is limited data about its applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of this study was to assess the impact of ERAS protocols following emergency caesarean delivery in a low resource setting.

Eligibility Criteria:
Inclusion Criteria:

* We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.

Exclusion Criteria:

* Exclusion criteria included refusal to consent, pregnancy complicated by preeclampsia, antepartum hemorrhage, malaria, gestational diabetes mellitus, physical disability that would prevent postoperative mobilization and mental illness precluding comprehension of protocols.
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients

The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 years or older, 40kg or heavier
* Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ )
* Standard treatment failed or standard treatment intolerant, no standard treatment
* Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:

* Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
* Other clinical trial within 4 weeks prior to the first QLS31903 administration
* Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
* Prior treatment targeted on GPC3
* HBsAg/HBcAb positive and HBV-DNA\>10,000 copy/mL;HCV-Ab positive and HCV-RNA\>1,000 copy/mL
* CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease