bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Condition: Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder NOS; Adjustment Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Adjustment Disorders; Dysthymic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim of this study is to examine whether adolescent depression and the family
      context in which it develops is best treated using an individual adolescent intervention or
      an intervention that includes both the adolescent and the parents. This will be accomplished
      by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for
      Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed
      Adolescents and Parents (IPT-AP).
    

Detailed description: 
      The primary aim of this project is to examine whether adolescent depression and the family
      context within which it develops is best treated using an individual adolescent intervention
      or an intervention that includes both the adolescent and the parents. This will be
      accomplished by conducting a randomized controlled pilot study of Interpersonal Psychotherapy
      for Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed
      Adolescents and Parents (IPT-AP). Twenty-two families with adolescents (ages 12-17) who meet
      criteria for major depressive disorder, dysthymic disorder, depressive disorder NOS, or
      adjustment disorder with depressed mood and also report elevated levels of parent-adolescent
      relationship problems will be randomized to receive IPT-A or IPT-AP. Assessments will be
      administered at screening, baseline, week 4, week 8, week 12, week 16 (post-treatment), and 4
      months post-treatment. Outcome measures will include depression symptoms, quality of
      parent-adolescent relationships, parents' and adolescents' communication skills (assessed
      through observational coding of a parent-adolescent conflict negotiation task), and
      adolescents' physiological stress responses to negotiating conflict with a parent (assessed
      through collection of salivary cortisol). Identifying the best approach to treating both the
      adolescent's depression and the family environment in which it develops and is maintained
      would have significant implications for the long-term outcomes of depressed adolescents and
      their families.
    

Intervention name(s): Interpersonal Psychotherapy for Depressed Adolescents; Interpersonal Psychotherapy for Depressed Adolescents and Parents
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 psychotherapy sessions delivered over 16 weeks; 12 psychotherapy sessions delivered over 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow
Condition: Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)
MeSH terms: Ulnar Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Ulnar nerve compression at the elbow is a common problem and can significantly affect hand
      function in severe cases. The current, standard treatment is Ulnar nerve decompression with
      or without transposition (moving the ulnar nerve to a site where there is less compression).
      In severe compression, the clinical results after this surgery are typically poor. Distal
      transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve
      (anterior interosseous nerve to ulnar motor fascicles) have been suggested to "supercharge"
      or augment hand muscles while nerve axons regenerate from the level of the elbow after
      decompression/transposition. In fact, this treatment is becoming widely adopted without clear
      evidence that it changes outcomes. The investigators propose to prospectively compare the
      effectiveness of ulnar nerve decompression/transposition versus decompression/transposition
      and distal nerve transfer.
    

Detailed description: 
      The purpose of this study is to prospectively compare the outcomes of patients with severe
      (intrinsic hand muscle dysfunction) compressive ulnar neuropathy at the elbow treated with
      ulnar nerve decompression and subcutaneous transposition alone versus ulnar nerve
      decompression with subcutaneous transposition and AIN to ulnar nerve reverse end-to-side
      transfer. The study objectives of this project are the following: 1. To prospectively compare
      the clinical outcomes of patients with severe ulnar neuropathy at the elbow who receive ulnar
      nerve decompression with subcutaneous transposition and AIN to ulnar motor reverse
      end-to-side nerve transfer versus decompression and subcutaneous transposition alone. 2. To
      prospectively compare the electrophysiologic outcomes (nerve conduction studies and EMG) of
      patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with
      subcutaneous transposition and AIN to ulnar motor reverse end-to-side nerve transfer versus
      decompression and subcutaneous transposition alone.
    

Intervention name(s): Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer; Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.
Intervention type(s): Procedure; Procedure
Other intervention name(s): experimental; standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is not being conducted in the United States.

      To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.)
      versus once daily (o.d.) in preventing the progression to disease "relapse".
    


Intervention name(s): Pimecrolimus; Pimecrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Pimecrolimus cream 1 % applied twice daily (b.i.d.); Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
Other intervention name(s): Elidel b.i.d.; Elidel o.d.
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis, children, infants, pimecrolimus, bid, od
Online Intervention for Depression: MOOD
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The study aims to examine the efficacy and acceptance of a self-help internet intervention
      "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive
      symptomatology decreases in the intervention group compared to a wait-list control group.
      Further aims are to ascertain changes in self-worth and quality of life, to assess subjective
      evaluation of the program and to examine whether expectations of the program's helpfulness
      would predict symptom reduction.
    

Detailed description: 
      The study aims to examine the efficacy and acceptance of a self-help internet intervention
      "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive
      symptomatology decreases in the intervention group compared to a wait-list control group.
      Secondary aims are to ascertain changes in self-worth and quality of life, to assess
      subjective evaluation of the program and to examine whether expectations of the program's
      helpfulness would predict symptom reduction. During the intervention period of six weeks,
      participants of the intervention group have access to the online program MOOD. Prior and
      following this period both groups complete a pre- and post-assessment. Participants of the
      wait-list control group receive access to MOOD following the post-assessment.
    

Intervention name(s): MOOD
Intervention type(s): Behavioral
Intervention description(s): MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury
      priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell
      costimulatory molecules in patients with a metastatic or unresectable locally advanced
      malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime
      doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The
      study will last approximately 104 weeks before starting long term follow up (FU).
    


Intervention name(s): MVA-BN-Brachyury/ FPV-Brachyury
Intervention type(s): Biological
Intervention description(s): Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 months
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subtotal Versus Total Thyroidectomy for Benign Goiter
Condition: Goiter
MeSH terms: Thyroid Diseases; Goiter
Study type: Interventional

Summary: 
      The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT
      over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of
      operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However,
      these potential advantages should outweigh the risk of morbidity associated with more radical
      thyroid resection.

      The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total
      thyroidectomy (TT) for benign bilateral thyroid disease.
    

Detailed description: 
      The extent of thyroid resection in bilateral multinodular non-toxic goiter remains
      controversial. Surgeons still continue to debate whether the potential benefits of total
      thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform
      total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal
      nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of
      total thyroidectomies are currently performed in high-volume endocrine surgery units, and the
      indication for this procedure include thyroid cancer, Graves disease and multinodular goiter.
      Recently there has been increasing acceptance for performing total thyroidectomy for
      bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers
      local recurrence rate and avoids the substantial risk of reoperative surgery, and involves
      only a minimal risk of morbidity. This common perception is based largely on
      single-institution retrospective data, a few multi-institutional retrospective experiences,
      and only a few small prospective studies comparing the outcomes of total vs. subtotal
      thyroidectomy.
    

Intervention name(s): thyroid resection
Intervention type(s): Procedure
Intervention description(s): bilateral subtotal versus total thyroidectomy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: benign thyroid disease; incidental thyroid cancer; recurrent goiter; revision thyroid surgery
A Phase 1 Study Comparing AVP-786 With AVP-923
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide
      [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady
      state.
    


Intervention name(s): AVP-786; AVP-923
Intervention type(s): Drug; Drug
Other intervention name(s): deuterated (d6)-dextropmethorphan/quindine sulfate; dextromethorphan/quinidine
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Pharmacokinetics; Healthy Volunteers; deuterated dextromethorphan; deuterated dextromethorphan with quinidine
CAM in Hospice Palliative Care in Taiwan
Condition: Cancer
Study type: Interventional

Summary: 
      The study aims to explore the effects of silver spike point (SSP) treatment on common
      symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer
      patients.
    

Detailed description: 
      The study aims to explore the effects of silver spike point treatment on common symptoms
      including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients.
      We will conducted a pilot study to evaluate the effects on different symptoms and then a
      prospective study will be conducted after validation of major effects.
    

Intervention name(s): SSP treatment
Intervention type(s): Device
Intervention description(s): SSP treatment 5 times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Complementary and alternative medicine; Hospice Palliative Care
Safety Study of Gene Therapy in Treating Lower Leg Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and preliminary efficacy
      of intramuscular injections of VM202 for subjects with critical limb ischemia.

      Subjects selected for this study will have critical limb ischemia that has not responded to
      standard therapy with symptoms including pain at rest and/or ischemic ulcers.
    

Detailed description: 
      The study will consist of four (4) cohorts with a total of 3 subjects enrolled in each cohort
      to VM202.For each dose cohort, VM202 will be administered as a local intramuscular injection
      in 2 divided doses with a 2-week interval between the injections. Preliminary efficacy
      (hemodynamic assessments), safety and tolerability will be evaluated at Baseline (screening)
      and at designated time points throughout the study.

      After all subjects in the first dose cohort have completed the 30-day (+ 2 days) follow-up
      visit following the first dose of the study drug, an interim safety evaluation will be
      performed with the submission of safety data to the Data Safety Monitoring Committee (DSMC).
      If the DSMC recommends continuing the study, the second dose cohort will be treated. This
      process will be repeated between the second and third dose cohort and between the third and
      fourth dose cohort.

      All four dose cohorts will be followed for up to 5 years from the time of the first dose of
      study drug administration.
    

Intervention name(s): VM202 2mg; VM202 4mg; VM202 8mg; VM202 16mg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 2mg intramuscular injection with the first half of the total dose given on Day 1 and the second half on Day 15; 4mg intramuscular injection, with half of the total dose given on Day 1 and the second half given on Day 15; 8mg intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.; 16mg dose intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lower leg ischemia; peripheral artery disease
Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the
      pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.
    

Detailed description: 
      This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate
      Drug-Drug Interaction of CG100650 in healthy volunteers.

      Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14
      days (13 subjects each).

      [Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol

      Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline;

      Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and
      collecting AE, CM by different Group.
    

Intervention name(s): Polmacoxib and Tramadol combination; Polmacoxib; Tramadol hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tramadol hydrochloride , Polmacoxib; Polmacoxib; Tramadol hydrochloride (HCl)
Other intervention name(s): Tramadol
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
Masking: None (Open Label)
Primary purpose: Treatment
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      In an era of delayed fertility plans, there is an increasing need for a reliable method to
      predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B,
      Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and
      number of antral follicles are non-specific and with questionable reliability. The
      biochemical tests represent the function of production of androgens, as a predictor of
      ovarian reserve, has not been tested yet.

      Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of
      theca cells for estimating the ovarian reserve, and by that to calculate better the chance
      for IVF cycle success
    

Detailed description: 
      20 women >40 years old and 20 women <35 years old, attended to our IVF unit were included in
      the study. Another 20 other young women (<35 years) with poor response in previous IVF cycles
      will be participate. All participants received a single hCG 10000 IU injection on cycle day
      2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken
      prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be
      compared with IVF results
    

Intervention name(s): s.c. human chorionic gonadotropin (Pregnyl)
Intervention type(s): Drug
Intervention description(s): S.C. Pregnyl 10000 IU once
Intervention MeSH terms: Chorionic Gonadotropin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IVF; ovarian reserve; androgens; thecal cells; Fertility Agents, Female
Does Metabolic Syndrome Exist in Anorexia Nervosa?
Condition: Anorexia Nervosa; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to examine whether body fat distribution changes that occur with
      weight gain in women recovering from anorexia nervosa are transient or persistent, and if
      they are associated with other features of Metabolic Syndrome.
    


Intervention name(s): Calorie controlled diet
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Keywords: eating disorders; anorexia nervosa; body fat distribution; metabolic syndrome; visceral adipose tissue
Treatment of Gingival Recession Using Mesenchymal Stem Cells
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of patients with gingival recession by injection of autologous adipose-derived
      mesenchymal stem cells mixed with collagen gel
    

Detailed description: 
      Treatment of patients with gingival recession by injection of autologous adipose-derived
      mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). The volume of the mixture
      is divided into 4 equal injections in the gingival region of one tooth (one place injection
      volume is 0.05 ml of mixture).
    

Intervention name(s): mesenchymal stem cells; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): autologous mesenchymal stem cells; standard treatment according to clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gingival Recession