cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

Background

Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety.

Aim of the study

The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety.

Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of severe health anxiety (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* At least 18 years old
* Able to read and write in Swedish

Exclusion Criteria:

* Other primary axis-I disorder
* Ongoing substance abuse or addiction
* Current or previous episode of psychosis or bipolar disorder
* Severe major depressive disorder
* Higher than 5 on the suicidality scale of the Mini International diagnostic Interview
* Non-stable antidepressant medication (changed during the last 2 months) or not agreeing to keep dosage constant throughout the study
* Ongoing concurrent psychological treatment for severe health anxiety
* Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy during the recent year
* Ongoing serious somatic disorder
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)

Eligibility Criteria:
Inclusion Criteria:

1. Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
2. Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)

Exclusion Criteria:

1. Unalbe to undergo upper GI endoscopy
2. H. pylori positive
3. Those who cannot write a clinical trial subject diary
4. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy
Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
* HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
* Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
* 18-70 years old;
* ECOG PS 0-1;
* Life expectancy is not less than 12 weeks;
* At least one measurable lesion according to RECIST 1.1;
* ANC ≥ 2.0×10\^9/L, PLT ≥ 100×10\^9/L, Hb ≥ 90 g/L; TBIL≤1.5ULN; ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis); BUN and Cr≤1.5×ULN;
* LVEF ≥ 50% and QTc≤470 ms.

Exclusion Criteria:

* Patients with symptomatic brain metastasis;
* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
* patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period;
* Participated in other drug clinical trials within 4 weeks before admission;
* Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past;
* Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years;
* A history of immunodeficiency, including HIV positive, HCV, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known;
* Has suffered from any heart disease;
* Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
* According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.);
* Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever(\> 38.5 ℃) of unknown origin occurs during the screening period/before the first administration;
* Researchers believe that patients are not suitable for any other situation in this study.
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Eligibility Criteria:
Inclusion Criteria :

* Subject vaccinated and who completed the Phase II VVL04 trial.
* Informed consent form signed.
* Subject able to comply with all trial procedures.
* Subject entitled to national social security.

Exclusion Criteria :

* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse

A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 6 months of age or older
* Subject must have a head lice infestation present at baseline
* Subject/caregiver must read English or Spanish at a 7th grade level
* Subject must have an appropriately signed Informed Consent agreement
* Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
* Subject agreement to not use any other form of lice treatment during the course of the study
* Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits

Exclusion Criteria:

* Individuals with a history of irritation or sensitivity to pediculicides or hair care products
* Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
* Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
* Individuals receiving systemic or topical drugs that may interfere with the study results
* Individuals who have participated in a clinical trial within 30 days of enrollment
* Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment
* Females who are pregnant or nursing
* Sexually-active females not using effective contraception
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptoms of PAD
* Scheduled for DSA

Exclusion Criteria:

* Critical leg ischemia manifested by ulcers, gangrene or leg amputation
* Laboratory evidence of iron overload, liver disease, pregnancy
* History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy
* Clinical concerns about co-morbidities, subject suitability
Early Ambulation to Reduce Hospital Length of Stay

Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also reduced adverse events such as venous thromboembolism (VTE). We will test if a patient wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation, decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable pedometer or usual care. Patients randomized to the study intervention will receive a wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study outcome measures to be compared between the pedometer and no pedometer group include hospital LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence of VTEs, patient experience, and costs (secondary outcomes).


Eligibility Criteria:
Inclusion Criteria:

1. Patients ages \> or equal to 18 years
2. Patient has capacity to undergo informed consent
3. Admitted to UF Health Jacksonville 8N progressive inpatient unit
4. Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission
5. Patient with a Fall Predictive Analytics score category of "low risk"
6. Patient with a Morse Fall Scale (MFS) of \< or equal to 50
7. No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

Exclusion Criteria:

1. Patient \< 18 years of age
2. Patient without capacity to undergo informed consent
3. Patient with a 'do not ambulate' order or has order for bed rest or other contraindication to ambulation (i.e., fall risk) or dependent on more than minimal assistance to ambulate
4. Patient with a Fall Predictive Analytics score category of "high risk"
5. Patient with MFS \> 50 or labelled by clinical team as fall risk
6. Non-English speaking
7. In law enforcement custody or ward of the state
8. Pregnancy
Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants

The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.

Objective:

Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.

Methods and material:

* Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial.
* Sample:

  * Patients with schizophrenia, schizoaffective disorder or schizophreniform disorder (DSM-IV); aged 18-40 years; less than 15 years since first psychotic symptoms;admitted to a psychiatric department within the previous 21 days before screening; speaks fluently a Scandinavian language;treated with antipsychotics; written informed consent;no known allergy to trial agents;no substance dependence (DSM-IV);no warfarin currently or anamnestic indicators of impaired haemostasis. Planned: 200 patients. Actually included: 99 intent-to-treat patients.
  * Healthy controls: aged 18-40 years;no mental disorder (DSM-IV). Included: 20 persons.
* Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive assessment battery. Niacin skin flush test. General medical assessment.
* Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration (ELISA technique), a range of other biochemical tests.
* Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364 mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
* Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and multivariate methods (SPSS 12.0 - PASW Statistics 18).

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia, schizophreniform disorder or schizoaffective disorder (DSM-IV)
* Admitted to a psychiatric hospital/department within the previous twenty-one days before screening
* Less than fifteen years, in retrospect, since first psychotic symptoms (DSM-IV 295, criteria A,1-4)
* Age 18-40 years
* Speaks fluently a Scandinavian language
* A written informed consent must be obtained before any trial-related activities

Exclusion Criteria:

* A diagnosis of substance dependence (DSM-IV)
* Known allergy to study medication
* Currently taking warfarin or having anamnestic indicators of impaired haemostasis (profuse bleeding, except epistaxis)
Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, dose of hyperbaric bupivacaine used, combination with adjuvants, hemodynamic management, and impact of these measures on maternal experience are not uniform. This study aims to describe practices of spinal anaesthesia for caesarean section in France to improve practices, guide new studies and establish protocols.

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, techniques of spinal anaesthesia are varied. Dose of hyperbaric bupivacaine used may shifted, varying intensity of sensor block but also hemodynamic side effect. Likewise, use of adjuvant is frequent and differs between centres. Management of the maternal hemodynamic is also discussed. While it is recognized that intraoperatively vascular filling alone is not effective, use of vasopressors is not unequivocal. For example, recent studies support the use of norepinephrine.

Finally, maternal experience is a hot topic. Although insufficient anaesthesia is rare, it is often overlooked. There are few recommendations on the intraoperative treatment of insufficient anaesthesia and to the management of post-traumatic stress that it lead to.

The objective of this study is to describe practices of spinal anaesthesia for scheduled or non-emergency caesarean section (also named "green code") in France by detailing several points:

Technique of spinal anaesthesia:

* The anaesthesia solution used (doses and adjuvants)
* Management of hemodynamic
* Management of insufficient anaesthesia
* Maternal experience It aims to make an inventory of practices, to orient future studies, guide practice and the realization of protocols.

It is an observational study unfolds from 2021 to 2022. It concerns 11 French centres and 600 women. Data are collected with an online questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Affiliation to social security system
* Scheduled or elective Caesarean section (green code) under spinal anesthesia

Exclusion Criteria:

* Refusal to participate in the study
* Code red Caesarean section or general anesthesia decision
* Complicated" Caesarean section or combined spinal-epidural technique
* Presence of an epidural catheter
* Performing a combined spinal-epidural technique (even if the epidural catheter is not used)
* Contraindication to spinal anaesthesia (coagulation disorder, vertebral-medullary pathologies)
* Patient under guardianship or curatorship
Minima Clinical Study

Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders
2. Age ≥ 18 years old
3. Life expectancy over 5 years
4. Any race
5. Ambulatory patients
6. Painful primary coxarthrosis
7. Painful secondary coxarthrosis
8. Avascular necrosis
9. Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits
10. Signed study-specific Informed Consent Form

Exclusion Criteria:

1. Body mass index over 28 kg/m2 for the modular version
2. Requiring revision of previous standard femoral stem
3. Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator
4. Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS\< 60 points
5. Significant proven or suspicious infection of the target hip
6. Any serious infectious disease before the study according to the Investigator
7. Muscular insufficiency that may compromise functional recovery
8. Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator
9. Known or suspicious hypersensitivity to the metal of the implant
10. Recurrent medical history of immune-mediated reactions or other systemic immune disorders
11. Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator
12. Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit
13. Previous organ transplant
14. Any intercurrent chronic disease or condition that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation
15. Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition
16. Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
17. Current alcoholism, and/or any known current addiction to pain medications or drugs
18. Any psychiatric illness that would prevent comprehension of the details and nature of the study
19. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit
20. Unwillingness or inability to comply with rehabilitation and to return for follow-up visits
21. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period