cyrilzakka/clinical-trials huggingface dataset:
Arresting Vertical Transmission of Hepatitis B Virus

The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

Hepatitis B virus (HBV) is a leading cause of chronic liver disease globally, with devastating complications such as cirrhosis, hepatocellular carcinoma and death. Vertical transmission (VT) of HBV is a worldwide public health concern because infected children are at high risk of developing chronic liver disease. It is a particular problem in the Democratic Republic of the Congo (DRC); preliminary data suggest that approximately 3% of children have HBV infection due to VT. However, VT is preventable. Pregnant women with risk factors can be identified and treatments given which can virtually eliminate transmission. Unfortunately, despite the high burden of HBV, neither HBV testing of pregnant women nor interventions to prevent HBV VT are routinely performed in the DRC and elsewhere in sub-Saharan Africa. This pilot feasibility study will address this healthcare gap by identifying women with HBV early in their pregnancies and intervening to prevent VT by (1) treating mothers with high-risk HBV (defined as HBeAg positivity and/or HBV viremia \>10\^6) with tenofovir and (2) providing HBV vaccine to HBV-exposed infants within 24 hours of birth. This pilot study will piggyback onto an existing study that is evaluating the DRC's HIV Prevention of Maternal-to-Child Transmission Option B+ (PMTCT+) strategy. Combining programs to prevent VT of HBV and HIV enables using the same personnel and infrastructure to implement both interventions. Furthermore, tenofovir, used to treat HBV infections, is already used in the DRC to treat HIV. Researchers hypothesize that utilizing the existing PMTCT+ infrastructure in the DRC will provide a cost-effective platform to prevent HBV VT. If effective, this model of treatment will inform future public health efforts and wider policy recommendations that can be applied in the DRC and throughout the Sub-Saharan African region to reduce the burden of HBV.

Eligibility Criteria:
Inclusion criteria:

* Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation
* Infants born to HBV-positive women

Exclusion criteria:

* Participants who are severely sick and who require prolonged hospitalization.
* Any women who do not intend to stay in Kinshasa for prenatal care through delivery
Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur

This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.

Number of 120 diagnosed with heel spur patients, will be allocated randomly into one of three treatment groups or into the control group. Assignment to a group is random, but before that happens patients will be questioned about inclusion and exclusion criteria of the study. Depending on group allocation, patients in treatment groups will receive one of the following physical therapy treatments:

* ESWT (once a week for 10 weeks)
* ultrasound (three times a week for 5 weeks)
* electric field diathermy (three times a week for 5 weeks).

Patients allocated in control group, will receive a sham laser therapy (only the timer on the machine activated) three times a week for 5 weeks.

Regardless of affiliation to the group, each patient will also receive kinesiotherapy treatment.

At the beginning of the study, each patient receives the "Information for the patient," describing the exact course of each stage of the study, then signs a "Form of informed consent to participate in the study.". The next stage of the study is to fill in the participant survey questionnaire and physical examination provided by the researcher.

Assessment of improvements will be made twice: right after the therapy and two months later. Every stage of the study is carried out by one and the same investigator.

Eligibility Criteria:
Inclusion Criteria:

* heel spur (calcaneal spur) diagnosed by a doctor based on X-ray examination, diagnostic ultrasonography or MR
* signed informed consent
* heel pain for at least one month

Exclusion Criteria:

* pregnancy
* generalized acute infection (fever, cough, runny nose)
* local infection in the treated leg (wound, swelling)
* cancer
* injections of corticosteroids in the last six weeks
* pacemaker
* acute inflammation of the joints of the lower limbs
* inflammation of the veins
* Fresh fractures, post-traumatic
* osteoporosis
* Reynaud's disease
* Burger disease
* atherosclerosis
* after surgery condition before removing stitches
* High blood pressure
* after CT with contrast condition in the last two weeks
* The state of the lumbar puncture
* Strong imbalance
* Condition after myocardial infarction in the last six weeks
* Rheumatoid arthritis
* Ankylosing spondylitis
* Significant leg ulcers
* diabetes
* The risk of bleeding in the muscle tissue
* Thromboangiitis
* Hypersensitivity skin in the treated section
* A tendency to hemorrhage
* Pathological arrogance bone under the skin in the treated section
* Metal implants and surgical implants in the area of the lower limb subjected to therapy
Study of DC-CTL Combined With CIK for Advanced Solid Tumor

Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors.

Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with treatment-refractory advanced colorectal cancer can not accept operation .
2. Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months;
3. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
4. Without any other malignant disease;
5. With more than one scalable lesions
6. Patients Voluntary attempt, and informed consent.
7. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating;
3. ECOG perform status ≥ 2;
4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..
Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy

The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal and postmenopausal women
* Indication for in-office operative hysteroscopy

Exclusion Criteria:

* Denied consent
* Use of analgesic drugs before the procedure
Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control

feasibility and Site selection has been completed in the US and India

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of one or both knees
* on stable NSAID or none due to intolerance
* women either post menopausal or on stable birth control
* no clinically significant disease or or abnormal laboratory values
* signed informed consent, communicate effectively, understand and comply with all study requirements

Exclusion Criteria:

* serious or unstable medical or psychological condition
* known sensitivity to honeybee venom, histamine or lidocaine
* history of asthma
* any clinically significant ECG abnormalities
* any clinically significant laboratory values OOR
* history of drug or alcohol abuse
* history of joint injury and forms of inflammatory arthritis
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain

The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.

Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age or older
* Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.
* Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.
* Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
* Written informed consent.

Exclusion Criteria:

* Known allergy or significant reaction to opioids.
* History of chronic opioid use or opioid abuse within 6 months prior to study entry.
* History of alcohol or substance abuse within the last 3 years.
* Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
* Have been a previous participant in an oxymorphone clinical trial.
* Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) drug within 2 weeks prior to study entry.
* Are currently taking or have taken St. John's Wort \>1000 mg/day within 2 days prior to study entry.
* Use of long-acting oral and parenteral analgesics (opioid, non-opioid or non-steroidal anti-inflammatory drug \[NSAID\]) within 12 hours (at least 24 hours for cyclooxygenase-2 \[COX 2\] analgesics) prior to receiving study medication.
* Are not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs; serotonin reuptake inhibitors; amphetamines used for attention-deficit hyperactivity disorder (ADHD)
* Have a history of seizure.
Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres?

Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily shake. The DBS surgical procedure involves implanting an electrode deep within the brain which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the vocal manifestation of ET and a number of individuals have both ET and EVT, and when these patients are implanted for their ET, their EVT symptoms are often also mitigated. This study aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition to this, we hope to determine which hemisphere of the brain is responsible for larynx control: left or right.

Essential Tremor (ET) is the most common movement disorder in adults, affecting approximately 5% of individuals over the age of 65. Of this 5%, roughly 20% of these patients suffer from Essential Voice Tremor (EVT): the phonatory manifestation of ET. Patients with EVT lose their ability to speak due to a tremor in the muscles of the larynx, pharynx, palate, and tongue. Because of this, an individual's quality of life is limited because they can no longer communicate effectively.

The purpose of this study is to quantify to what degree Deep Brain Stimulation improves Essential Voice Tremor. In addition to this, we hope to examine which brain hemisphere is responsible for these positive results: right, left, or both, in a prospective, randomized, double-blinded manner. By finding out more about the subcortical control underpinning speech, we will be able to improve our treatments and understanding of EVT and other neurological speech disorders.

Eligibility Criteria:
Inclusion Criteria:

* Participant has been implanted with the DBS for ET
* Participant has significant voice tremor as determined by our laryngology/speech-language pathology team

Exclusion Criteria:

* Participant does not have history of aphasia or other speech/language deficits
* Participant does not have history of stroke or multiple sclerosis
A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma

The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.

Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years or older
2. Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
3. Subjects in general good health
4. Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
5. Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion Criteria:

1. Subjects under 18 years of age
2. Subjects who are pregnant and/or lactating
3. Subjects who are unable to understand the protocol or to give informed consent
4. Subjects diagnosed with mental illness
5. Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
6. Subjects who have had a chemical peel in the past 3 months
7. Subjects who have used a prescribed retinoid in the past 3 months
8. Subjects with a bleeding disorder
9. Subjects with a history of abnormal wound healing
10. Subjects with a history of abnormal scarring
Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia

In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) may be effective in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60 years, schedule for elective abdominal hysterectomy surgery under general anesthesia.

In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) would be effective in reducing intraoperative isoflurane requirement needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for elective abdominal hysterectomy surgery under general anaesthesia.

The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements) in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, aged 18-60 year scheduled for elective abdominal hysterectomy surgery under general anaesthesia.
* American Society of Anaesthesiology (ASA) physical status I or II.

Exclusion Criteria:

* American Society of Anaesthesiology (ASA) physical status ≥ III.
* Allergy or hypersensitivity to pregabalin.
* Patient on calcium channel blocker or anticonvulsant.
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Currently taking an approved HBV oral antiviral medication
* Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months)
* Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year)

Key Exclusion Criteria:

* Cirrhosis
* Inadequate liver function
* Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)
* Evidence of hepatocellular carcinoma
* Significant cardiovascular, pulmonary, or neurological disease
* Females who are pregnant or may wish to become pregnant during the study
* Received solid organ or bone marrow transplant
* Use of another investigational agents within 3 months of screening
* Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
* History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease
* Known hypersensitivity to study drug, metabolites or formulation excipients
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Second Survey of Intensive Care in India

INDICAPS was the first large scale, multicentre survey launched by the ISCCM. The aim was to gather information about ICUs, organizational characteristics, patient casemix, the types and severity of illness, monitoring and therapeutic modalities used, types of infections, and other such data. This was performed between July 2010 and April 2011 and published in 2016.\[1\] Over the last 8 years, there has been a significant difference in the delivery of intensive care services, critical care education, socioeconomic indicators, antibiotic resistance patterns and other aspects of practices in Indian ICUs. It is therefore necessary to revisit and resurvey the current trends in intensive care practices in India, and to reflect the vast spectrum of critical care illness, services and practices.

Similar to INDICAPS, which was a point-prevalence study of all patients present in the ICU on four different days over a one-year period, INDICAPS II will record data of all patients admitted to the ICU on 4 different days.

INDICAPS II will record data of all patients admitted to the ICU on 4 different days (August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019) in a cross-sectional design. Data collection includes:

1. On admission: demographic characteristics, comorbidities, source of admission, primary and secondary admission diagnoses,
2. Baseline data (on the study day), including parameters used to calculate SAPS II score and SOFA score and infections,
3. Information on monitoring modalities, mechanical ventilation, nutrition, fluid therapy, other routine ICU practices

c. Outcome at ICU and hospital discharge d. Organisation of ICU services

Eligibility Criteria:
Inclusion Criteria:

* All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019

Exclusion Criteria:

* None
Invasives Aspergillosis in Acute Myeloid Leukemia

Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.

Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* acute myeloid leukemia
* intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)

Exclusion Criteria:

* \< 18 years
* pregnancy
* no intensive chemotherapy (palliative treatment, azacytidine...)