cyrilzakka/clinical-trials huggingface dataset:
Antepartum Etonogestrel Contraceptive Implant Insertion at Term

Short-interval pregnancy (SIP) or rapid, repeat pregnancy is defined as a pregnancy within one year of prior delivery. These pregnancies are often unintended and are associated with adverse risks. Low contraceptive initiation during the postpartum period is a contributing factor to SIP. This study will be the first to investigate the initiation of a highly-effective, immediately active contraceptive device during the antepartum period. The antepartum period serves as an ideal time for postpartum contraception counseling, due to patients' active involvement with the healthcare system. The pharmacokinetic analysis proposed in this study will be the first to investigate whether and to what extent ENG hormone crosses the placenta. This data will enrich understanding of the pharmacology of exogenous progestins administered during pregnancy and provide information that can be incorporated into future patient counseling regarding the risks of fetal exposure with exogenous progestin use.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (ages 18-34 years) ≥37 weeks gestational age who are interested in using an ENG contraceptive implant for their postpartum birth control method.
* Women with a history of at least one uncomplicated vaginal delivery at term who have received routine prenatal care (at least five visits) including an anatomy ultrasound with confirmed dating.

Exclusion Criteria:

* Women outside the gestational age outlined above.
* Women who are seen outside of the enrolling clinics.
* Women 35 years and older at the time of anticipated delivery, as these women meet the clinical definition of advanced maternal age which has been associated with increased adverse events in pregnancy.
* Women with any condition that necessitates a medically indicated delivery (e.g. diabetes mellitus, any hypertensive disorder), multiple gestations, fetal anomalies, Class III obesity (body mass index \>40), concurrent use of either an injectable or vaginal progestin, and any concerns related to ENG implant use based on the US Medical Eligibility Criteria for Contraceptive Use (defined as a class 3 or 4 recommendation).
Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy.

The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.

* Design: randomized multiple center clinical trial, open label
* Arms: intravenous 4.2% Sodium Bicarbonate vs no additional treatment
* Inclusion: age of 18 yo or above, critically ill patient with a SOFA score of 4 or above, lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below
* Exclusion: single respiratory disorder (PaCO2 \> 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24 ; acute diarrhea, ileostomy or biliary drainage ; stage IV kidney failure or chronic dialysis ; tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol) ; PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)
* Randomization: website randomization with stratification on age, presence of sepsis at inclusion, renal failure
* Intervention: experimental arm: intravenous 4.2% Sodium Bicarbonate 125 to 250ml in 30min up to 1000ml/24h. The target is a plasma pH of 7.30 or above.
* An interim statistical analysis is planned when 200 patients will be included

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 yo or above,
* Critically ill patient with a SOFA score of 4 or above,
* Lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below

Exclusion Criteria:

* Administration of Sodium Bicarbonate 24 hours before inclusion
* Single respiratory disorder (PaCO2 \> 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24
* Acute diarrhea, ileostomy or biliary drainage
* Stage IV kidney failure or chronic dialysis
* Tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol)
* PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)
Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy

This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male Chinese subjects aged ≤ 70 years
* Subjects with documented severe or moderately severe hemophilia B (FIX activity of ≤ 2%)
* Subjects have received FIX products for ≥ 150 exposure days (EDs) (subjects aged ≥ 6 years) or ≥ 50 EDs (subjects aged \< 6 years)
* Subjects have no confirmed prior history of FIX inhibitor formation

Exclusion Criteria:

* Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein.
* Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
* Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
* Currently receiving a long-acting recombinant FIX treatment such as coagulation factor IX (recombinant), Fc fusion protein (Alprolix®).
* Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the subject's participation in the study.
Cardiovascular Disease (CVD) in Haemophilia

Life expectancy of hemophilia patients has improved considerably during the past decades and is approaching that of the general population. Hemophilia patients are therefore likely to be confronted with age-related disorders in addition to their primary illness and related diseases. Little is known about the occurrence of age-related co-morbidity, especially cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD risk factors has been made so far.

The aim of our study is to assess the occurrence of CVD and its risk factors in a large cohort of haemophilia patients.

In this prospective multicenter cohort study in a group of 700-800 male patients with haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD history and CVD risk factors will be collected at baseline and compared with the general age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated and also compared with the general population. During a follow-up period of 5 and 10 years the occurrence of CVD events will be recorded and compared with the expected occurrence based on the QRISK2 scores and with data from the general population.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A or B (mild, moderate or severe)
* Male gender
* Age 30 years or older
* Treated at participating haemophilia treatment center

Exclusion Criteria:

* No specific exclusion criteria
Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve

According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.

Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling.

The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Introduction:

According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.

The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Patients and Method:

All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled.

Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection.

Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate .

Thirty patients will be included over 18 months.

Eligibility Criteria:
Inclusion Criteria:

Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.

Exclusion Criteria:

Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO \> II Suspected Indocyanine Green allergy
Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure

Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres.

Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .

Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.

Eligibility Criteria:
Inclusion Criteria:

* • Patient with disburbed thyroid function and candidate for for thyroidectomy

Exclusion Criteria:

* Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.
Prevention and Treatment of Patient Before, During, and After Covid-19 Infection

AntiCov-220 prevents and treats before, during, and after infection with SARS-Cov-2. The composition is fractionally extracted from herbs, using flavonoids, isoflavonoids, and pregnenolone in combination with ascorbic acid as the key compounds in preventing and killing SARS-CoV-2; increase antibodies and protect cells; supplementing precursors to help the body strengthen antibodies and reduce the risk of infection; destroy spike protein, toxic protein, help prevent blood clots causing stroke; restore the physiological function of cells after virus infection; helps the body to stabilize the amount of cortisol in the blood as well as stabilize the production of specific antibodies. The composition participates in anti-inflammatory and cells protecting process, bringing blood cortisol, B-lymphocytes, Cyfra 21-1, WBC, CRP, fever, dyspnea, and other signs of respiratory tract inflammation to a normal state and normal limit.

AntiCov-220 can eliminate COVID-19 and its variants at a very early stage when they have not had enough time to multiply and cause disease. AntiCov-220 contains precursors, flavonoids, special enzymes responsible for protecting human cell membranes and destroying cell membranes of some viruses, especially, COVID-19 cannot replicate in the presence of AntiCov-220 in the body.

AntiCov-220 contains precursors of cortisol. As the investigators know, cortisol has a cell anti-inflammatory, blood pressure regulation, blood sugar regulation, energy booster, and anti-stress role. It provides precursors to help direct and balance the amount of cortisol in the body that has been imbalanced before.

AntiCov-220 contains flavonoids and Isoflavonoids that are cytoprotective antioxidants, clinically proven to destroy SARS-CoV-2, HBV, HIV, HCV, viruses, reduce complications after COVID-19 infection, prevent neurological sequelae, stroke, cardiovascular sequelae, respiratory sequelae, ...

The anti-inflammatory, stress-reducing, cell-protective, anti-viral, and immunosuppressive process are performed by an in vivo method that has proven its effectiveness more than ten years ago. AntiCov-220 is an innovative product that can fight against COVID-19 and its variants in the current epidemic situation.

AntiCov-220 is committed to protecting the community of people infected with HBV, HIV, HCV, SARS-CoV-2 against the risk of the COVID-19 pandemic and its mutations.

AntiCov-220 easy to implement, highly effective, and helps reduce public health costs, which is essential in protecting human health.

AntiCov-220 can be used alongside with current standard treatment regimens prescribed by the World Health Organization.

Eligibility Criteria:
Inclusion Criteria:

* All patients with underlying medical conditions who have been taking medications for these conditions.
* Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
* The cancer patients are stable.
* Patients with congenital or acquired immunodeficiency.

Exclusion Criteria:

* Unstable cancer patients.
DELIVER Evaluation in Nigeria

The DEcent LIVelihoods for small-scale producers delivered through Economic \& Resilient food systems in Nigeria (DELIVER) (2024-2027) project is designed to address the low per capita consumption of vegetables and variety of vegetable consumption in northern Nigeria by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption among farmers and their neighbors. The objective of this evaluation is to assess the effectiveness of GAIN's DELIVER program for increasing the quantity and variety of vegetables consumed by smallholder farmer households participating in the program and by neighbor households. This evaluation will use a quasi-experimental design to assess the impact of GAIN's DELIVER programs on the quantity and diversity of vegetables consumed by smallholder farmers and non-farming neighbor households. The evaluation will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. RE-AIM is a framework that is useful for evaluating the program impact of multifaceted and multilevel interventions.


Eligibility Criteria:
Inclusion Criteria:

* Farmer household member or neighbor household recruited by DELIVER farmer
* Located within the intervention LGA
* Farmer must be a member who is participating in the DELIVER project
* Adult who is ≥ 18 years old
* Able to speak English or Hausa
* Provide informed consent to participate in the study
Curing Atrial Fibrillation in Heart Failure

Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Persistent atrial fibrillation (AF)
* New York Heart Association (NYHA) II, III and IV chronic heart failure (CHF) despite optimal medical therapy for at least 3 months
* left ventricular ejection fraction (LVEF) \<35% - as measured by radionuclide ventriculography (RNVG)
* Patients with CHF secondary to ischaemic and non-ischaemic aetiology

Exclusion Criteria:

* QRS duration \>150ms (or QRS 120-150 with evidence of mechanical cardiac dysynchrony)
* Magnetic resonance imaging (MRI) - incompatible metallic (ferrous) prosthesis
* Primary valvular disease as a cause of CHF
* Reversible causes of CHF
* Acute myocarditis
* Patients aged 18 or less
* Patients having undergone revascularisation procedures within 6 months
* Paroxysmal AF
* Pregnancy
* Expected cardiac transplantation within 6 months
Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions

The purpose of this study is to evaluate the changes in clinical and imaging outcomes following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or Mechanical Debridement in subjects 18-50 years of age.

This is a non-inferiority, prospective, single blinded, randomized, single-center study design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study). The sample size of 82 participants was calculated from a power analysis. The study was powered to detect at least a seven point change in KOOS pain score based on achieving 80% statistical power to detect a non-inferiority margin. Study duration will be until the last subject enrolled reaches 52 weeks post-operative.

The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand treatment group or mechanical debridement treatment group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy, the blinded assignment will be revealed to the subject.

Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent on the IRB approved consent form specific to the study, prior to study participation
* 18-50 years old
* Male or Female
* Suspected chondral damage in the following locations where debridement is indicated:

  * Medial femoral condyle
  * Lateral femoral condyle
  * Trochlea
  * Patella
* \< 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg)
* 1 or more chondral lesion(s) as noted on MRI

Exclusion Criteria:

* Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable)
* Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI, MACI, OATs)
* Concomitant procedures that are not allowed:

  * Lateral retinacular release
  * Excision of osteophytes
  * Subchondroplasty
  * Manipulation under anesthesia
  * ACL reconstruction
  * Quad tendon repair
  * Patellar tendon repair
  * Patellar tendon debridement
  * Multiligament reconstruction
* Pregnant and/or intending to become pregnant during this study period
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors

Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
* Agree to use a barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have hepatitis.
* Have any other serious medical condition besides HIV infection.
* Are allergic to indinavir, nelfinavir, or efavirenz.
* Have ever taken NNRTIs or protease inhibitors.
* Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)
* Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.
* Are enrolled or plan to enroll in another anti-HIV drug study during this study.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
The Impact of Chiropractic Activator Adjustments on Mental Rotation and Line Judgment Reaction Time

The purpose of this pilot study will be to assess the impact of chiropractic Activator adjustments on spatial cognitive abilities through initial assessment and testing in a healthy population aged 18 to 35.

This study seeks to assess the impact of chiropractic on cognition. Participants must be between 18 and 35 years of age. Within the past six months individuals may not participate if they have had any broken bones, accidents, or surgeries to their spine. Additionally, participants cannot have any mental disabilities, be pregnant, or have other conditions of the spine such as bone mineral loss.

Patients will receive a chiropractic exam and will be randomized to a sham (simulated chiropractic adjustment) or chiropractic adjustment intervention group. Prior to receiving either the sham or chiropractic adjustment, the participants will sit in front of a computer screen and will be asked to follow instructions and press a button on a keypad. There will be three different types of computer assessments that will take approximately fifteen minutes total. After the computer assessments the participant will receive either the sham or chiropractic adjustment. The chiropractic adjustment and the sham will both utilize a handheld instrument called an Activator. After the adjustment or sham the participant will take the computer assessments again. The total time this may take is ninety minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35
* In good health

Exclusion Criteria:

* pregnant
* medically diagnosed cognitive deficits
* medically diagnosed learning disabilities
* fractures, traumas, or surgeries to the spine within the past six months
* diagnosed osteoporosis, articular instability