cyrilzakka/clinical-trials huggingface dataset:
Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.

Secondary objectives:

To demonstrate that acupuncture can:

* reduce morbidity, fetal mortality and duration of childbirth;
* reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;
* to evaluate the tolerance.

In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only.

9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only.

Acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the French Acupuncture and Traditional Chinese Medicine College.

Each patient will have a 5-week follow-up in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Signed informed consent
* Woman carrying one foetus only
* at 37 weeks (+/- 2 days) of amenorrhea
* Without contraindication to vaginal delivery

Exclusion Criteria:

* Prior history of caesarean section
* Non-cephalic presentation
* Fetal macrosomia
* Multiple pregnancy
* Chronic fetal hypoxia
* Placenta praevia
* Risk of neonatal contamination
Obesity, Inflammation and Oxidative Stress

The purpose of this study is to determine whether or not Vitamin C (1000 mg/day) can reduce markers of inflammation, especially C-reactive protein (CRP), in obese persons with baseline CRP greater than 1 mg/dl.

The long-term objective of this project is to identify nutritional factors that can reduce the inflammatory component of obesity. Therapies to minimize obesity-related comorbidities are needed, and targeting inflammation may help slow the progression of obesity towards cardiovascular disease and insulin resistance.

Adipose tissue is a source of inflammatory cytokines, and obesity is now viewed as a chronic, low-grade inflammatory state. Inflammation itself is a contributor to the chronic diseases associated with obesity. C-reactive protein (CRP) is a key marker of inflammation, and as a downstream marker it provides functional integration of upstream cytokine activation associated with inflammation. We have previously shown that vitamin C, but not vitamin E, reduces CRP in active and passive smokers and in nonsmokers. The reduction is seen primarily in persons with CRP ≥1.0 mg/L, the CDC threshold for elevated cardiovascular disease risk. We also found that 75% of obese nonsmokers had CRP ≥1.0 mg/L.

The important observation of reduction in elevated CRP by vitamin C now needs to be confirmed in a rigorous study with adequate sample size, to permit justifiable conclusions about the potential usefulness of this agent in reducing inflammation in the obese. We will conduct a placebo-controlled, randomized trial in 552 healthy obese individuals with moderate CRP elevations (CRP ≥1.0 mg/L). Participants will be randomized to either 1000 mg/day vitamin C or placebo for a period of 2 months. We will also characterize the pathways through which this effect takes place by measuring cytokines and oxidative stress.

This project is important because if our previous finding is confirmed in this population, it could offer a low-cost alternative to use of statins to reduce inflammation in persons without other risk factors.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30
* hsCRP ≥ 1 mg/L
* Age 18+
* Member of Kaiser Permanente Health Plan of Northern California

Exclusion Criteria:

* Smoker
* Unwilling to discontinue vitamin supplements for study duration
* Unwilling/unable to use acetaminophen in place of OTC anti-inflammatory medications
* Use of certain medications
* History of certain medical conditions
Effects of Robotic Gloves Along With Task-oriented Mirror Therapy on Motor Functions of Hands in Sub-acute Stroke Patients

This study is randomized control trial and purpose of this study is to find effects of robotic gloves assisted task-oriented mirror therapy in comparison with task-oriented mirror therapy on motor functions of hand in sub-acute stroke patients.

Motor functions of the hand involve different movements and activities that the hand can perform due to the coordination of different muscles group in everyday activities which involves dexterity, manipulative skills and task performance skills which includes grasp, release and different types of grips of hand.

RATIONALE:

While the mirror therapy has been studied extensively and literature provide good quality of evidence for effects of mirror therapy on motor functions of hands the integration of pneumatic Robotic Mirror Therapy is relatively less explored .

and there is no comparison between Task oriented MT and pneumatic Robotic Mirror Therapy

SIGNIFICANCE This study will increase the understanding and therapeutic potential of robotic gloves assisted task-oriented MT mirror therapy and will demonstrate its efficacy as beneficial interventions.

Modern devices like robotic gloves can potentially increase patient compliance by providing positive outcomes, setting goals and improving functional performance.

They can make therapy more engaging, interactive and help the patients track their progress, which can motivate them to adhere to their rehabilitation program.

HYPOTHESIS ALTERNATE HYPOTHESIS There will be a statistically significant difference in the effects of Task oriented Mirror Therapy in comparison with Robotic gloves Assisted task-oriented Mirror Therapy on motor functions of hand in patients with sub-acute Stroke (p\<0.05).

NULL HYPOTHESIS There will be no statistically significant difference in the effects of Task oriented Mirror Therapy in comparison with Robotic gloves Assisted task-oriented Mirror Therapy on motor functions of hand in patients with sub-acute Stroke (p\>0.05).

Eligibility Criteria:
Inclusion Criteria:

* 40 years and above.
* Ischemic (MCA) stroke.
* Male and females both.
* Montreal Cognitive Assessment (MoCA score \>24 points).
* Motor power of proximal upper Extremity at least 3 with ability to reach out.
* FMA score for upper Extremity below 47
* Modified Ashworth spasticity score \<2 in hands and finger joints.
* Ability to sit for at least 60 minutes

Exclusion Criteria:

* Musculoskeletal problems such as severe pain in any joints of the paretic upper extremity.
* Contractures in shoulder, elbow, hand or finger joints.
* Severe Visual impairments.
Uretal Flow Assessment During Gynecological Procedures

The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral flow assessment after uterine artery occlusion during a conservative gynecological procedure.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for conservative gynecological procedure
* At least 25 years of age
* Cervix suitable for tenaculum placement
* Provides written informed consent.

Exclusion Criteria:

* Pregnancy
* One or more lower uterine segment fibroids
* Hydronephrosis as determined by renal ultrasound pre-procedurally
* Clinical diagnosis of urinary tract infection (UTI)
* In the medical judgment of the physician, such a procedure may compromise the patient's condition
* Inability to achieve bilateral occlusion with the clamp placement during the procedure.
Study of POMELLA™ Extract to Treat Prostate Cancer

This is a randomized, two-arm, placebo controlled trial to evaluate benefit of treatment using POMELLA™ extract on mechanisms known to drive prostate cancer. This research allows provision for biochemical and histological comparisons to be made between POMELLA™ treated and placebo treated prostate tissues removed from men with organ confined prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men 18 years or older (19 years in BC) with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:

  1. Clinical state T1-T2
  2. PSA \<20
  3. Gleason score ≤ 7
* ECOG performance status of 0-1.
* Life expectancy greater than 10 years.
* Able to understand and give informed consent.
* Laboratory values must be as follows:

  1. White blood cell count: ≥ 3,000/mm\^3
  2. Absolute granulocyte count: ≥ 1,500/mm\^3
  3. Platelets: ≥ 100,000/mm\^3
  4. Hemoglobin: ≥ 12g/dL
  5. Serum creatinine: ≤ 1.5 x ULN
  6. AST: ≤ 2 x ULN
  7. ALT: ≤ 2 x ULN
  8. Serum calcium: ≤ ULN
  9. Total bilirubin: ≤ 1.5 x ULN

Exclusion Criteria:

* Patients who are receiving any other investigational therapy.
* Patients who have received or are receiving any other treatment for their prostate cancer.
* Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
* Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
* Histologic evidence of small cell carcinoma of the prostate.
* Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
* Patients who are receiving any androgens, estrogens or progestational agents.
* Patients with a known hypersensitivity to pomegranates or composites of the capsules/placebo: hydroxypropyl methylcellulose, silicon dioxide or aerosol.
* Patients who are taking any drugs or natural health products which might impact biochemical tests (some examples include: spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort). A washout period of 30 days prior to commencing the study would be necessary for these compounds if required.
* Patients who have chronic active hepatitis.
* Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
Registry Construction of Intraoperative Vital Signs and Clinical Information in Surgical Patients

Monitoring data during anesthesia of surgical patient in the operation room will be collected and stored into the registry automatically. Patients' information and preoperative assessment from medical records will be included. Furthermore, intraoperative events will integrated and entered in the registry.

The purpose of the registry is to establish an automatic and accessible database of surgical patients for further retrospective studies.

Capture and storage of vital signs data are performed with our own developed data gathering program, Vital Recorder. The Vital Recorder program is a Windows® software and acquires time-synced patient monitoring data from the serial ports of multiple anesthesia devices like patient monitor, anesthesia machine, bispectral index monitor, cardiac output monitor, infusion pumps, etc. The retrieved data are stored on the local or network data storage.

Variables captured by the Vital Recorder program are as follows: heart rate, blood pressure, saturation, temperature, respiratory parameters, bispectral index, infusion history of target-controlled infusion pump, cardiac output, cerebral oxygen concentration, etc.

Time interval of the data is 1-2 sec for numeric variables. Resolution of waves (analog data such as ECG, plethysmogram, and pressure waves) is usually 500 Hz. Captured data of a patient is stored as a \*.vital file.

A laptop is connected to 4-6 anesthesia devices at the same time via serial connections. Patients enrolled (all of the surgical patients who undergo surgery at our hospital) receive routine anesthesia and surgery. Due to the program's automatic function, the program identifies the start and end of a case then automatically records the vital signs of every patient 24/365, once the program starts.

Patient information is additionally gathered from the electronic medical recording system (EMR). Data from the EMR are as follows: sex, age, weight, height, diagnosis, operation, anesthesia and surgery times, premedical history, perioperative lab data and medication.

List of vital files and patient information is integrated in an encrypted spreadsheet file.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery

Exclusion Criteria:

* N/A
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.

Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2, d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2, 400mg on day 3-14

28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.

Eligibility Criteria:
Inclusion Criteria:

* Known and written informed consent voluntarily
* Age ≥ 18 years
* Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:

  * ≥75 years or
  * Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \<= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \<= 65% or Forced Expiratory Volume in 1 second (FEV1) \<= 65%; Creatinine clearance \>= 30 mL/min to \< 45 ml/min; Moderate hepatic impairment with total bilirubin \> 1.5 to \<= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .
* patients who are suitable for intensive chemotherapy but refuse it
* Liver function meets the following criteria:

aspartate aminotransferase (AST) ≤ 3.0×ULN\*; alanine aminotransferase (ALT) ≤ 3.0×ULN\*; Bilirubin≤1.5×ULN\*; For subjects \<75 years old, the bilirubin level can be ≤3.0×ULN;

* Unless due to leukemic organ involvement.

  * Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)
  * Life expectancy ≥ 4 weeks

Exclusion Criteria:

* History of any malignancies prior to study entry with exception noted in the protocol.
* Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
* Participant has known active central nervous system (CNS) involvement with AML.
* Must not have received prior anti-AML treatment except for hydroxyurea
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices

Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.

This pilot study will be a prospective, randomized, controlled, open label, trial of HeartMate 3 (HM3) LVAD patients with 1:1 randomization to either apixaban or warfarin. All patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions for use (IFU).

Eligibility Criteria:
Inclusion Criteria:

1. Patients implanted with a HeartMate 3 LVAD
2. Age 18 or greater and able to provide written informed consent
3. Females of childbearing age must agree to adequate contraception

Exclusion Criteria:

1. History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding
2. Patients who are bridge to transplant and a current UNOS status 1-3
3. Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine)
4. Permanent right ventricular assist device at the time of LVAD implant
5. Patients with a mechanical heart valve
6. Patients with end-stage renal disease on dialysis
7. Pregnant patients
8. Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months
9. Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system.
10. Recent (\<48 hours) or planned spinal or epidural anesthesia or puncture
11. Prior history of known thrombophilia (e.g., factor V Leiden, prothrombin gene mutation, protein C or S deficiency, antithrombin 3 deficiency, hyperhomocysteinemia, antiphospholipid antibody syndrome) or indication for higher INR goal (\>2.5) with warfarin.
12. Thrombolysis within the previous 7 days
13. Patients with an allergy or contraindication to aspirin, warfarin, or apixaban
14. Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)
15. Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)
16. Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
17. Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)
18. Patients with active bleeding or a hemoglobin \< 8.0 g/dl
19. Total bilirubin \> 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis
20. INR \> 2.0 not due to anticoagulation therapy
21. Platelet count \<100,000 cells/mm3
Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments

This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

Abstract Objective: Evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge.

Methods: A randomized controlled effectiveness trial comparing single-dose tinidazole plus fluconazole (TF) to seven days of metronidazole plus three days of vaginal clotrimazole (MC) among 1570 women presenting with vaginal discharge in primary health care institutions of Ghana, Togo, Guinea and Mali. Participants were randomly allocated to one of the two treatments by research nurses or physicians using pre-coded envelopes. Effectiveness was assessed by symptomatic response on day 14.

Findings: The two treatment regimens had similar effectiveness: complete resolution was seen in 66% (TF) and 64% (MC) and partial resolution in 33% (TF) and 34% (MC) of participants (p=0.26). Effectiveness was similar among subgroups with vulvovaginal candidiasis, T. vaginalis vaginitis or bacterial vaginosis. The two treatment regimens had a similar effectiveness among HIV-infected (TF: n=76, 71% complete resolution, 28% partial; MC: n=83, 72% complete, 25% partial, p=0.76) and HIV-uninfected women (TF: n=517, 68% complete, 32% partial; MC: n=466, 65% complete, 33% partial, p=0.20). Cervical infections with N. gonorrhoeae, C. trachomatis and M. genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or T. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. Four fifths of women not relieved by single-dose TF had a favourable response when MC was administered as second-line treatment.

Conclusion: Single-dose TF is as effective as multiple-dose MC in the syndromic management of vaginal discharge, even among the HIV-infected. Given its low price and easier compliance, tinidazole/fluconazole should be considered as a first-line treatment of the vaginal discharge syndrome.

Eligibility Criteria:
Inclusion Criteria:

* women consulting for vaginal discharge
* local resident
* willingness and ability to consent

Exclusion Criteria:

* sex worker consulting for active screening
* main complaint of lower abdominal pain
* allergy to one of the study drugs
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:

1. Arthroscopy to collect cartilage;
2. Implantation following arthrotomy about 6 weeks following arthroscopy.

Both groups will follow the same rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* isolated femoral osteochondral lesion
* aged 18 to 45
* grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
* lesion depth under 10mm
* IKDC score below 55
* no prior surgical treatment

Exclusion Criteria:

* pregnancy or breastfeeding
* allergy
* arthrosis
* varus or valgus angle greater than 6°
* kissing lesion
* affection of the patella
* excessive laxity
* meniscal pathology history
* severe chronic disease
* BMI \> 30
* HIV, Hepatitis B, C, HTLV, Syphilis